Humulin (LY041001) Page 1 of 1

Size: px
Start display at page:

Download "Humulin (LY041001) Page 1 of 1"

Transcription

1 (LY041001) These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or other approved labeling. The approved drug label can be found at Therapeutic Area Alias Indication Trial ID Trial Title Trial Phase Endocrinology B5K-EW-IBHA Diabetes Comparative Pharmacokinetics and Pharmacodynamics of Common Clinical Doses of Human Regular U-500 Insulin versus Human Regular U-100 Insulin in Healthy Obese Subjects 1 Page 1 of 1

2 Return to list of studies Page 1 Summary ID# Clinical Study Summary: Study B5K-EW-IBHA Comparative Pharmacokinetics and Pharmacodynamics of Common Clinical Doses of Human Regular U-500 Insulin versus Human Regular U-100 Insulin in Healthy Obese Subjects Approval Date: 15-Nov-2010 GMT

3 Return to list of studies Page 2 Title of Study: Comparative Pharmacokinetics and Pharmacodynamics of Common Clinical Doses of Human Regular U-500 Insulin versus Human Regular U-100 Insulin in Healthy Obese Subjects Investigator(s): This single-center study included 1 principal investigator. Study Center(s): This study was conducted at 1 study center in 1 country. Phase of Development: 1 Length of Study: Date of first subject visit: 11 September 2009 Date of last subject visit: 04 December 2009 Objectives: The primary objective of this study was to evaluate the relative exposure (AUC0-t ) for human regular U-500 (U-500R, 500 units [U]/mL) versus human regular U-100 (U-100R, 100 U/mL) insulin after subcutaneous administration of a 50-U dose of each to healthy obese subjects; and to evaluate the relative exposure (AUC0-t ) for both formulations after administration of a 100-U dose. The secondary objectives of the study were: to evaluate the relative exposure AUC0-t' and the overall effect (Gtot) of the subcutaneous administration of a 100-U dose versus a 50-U dose of each formulation to healthy obese subjects; to compare other pharmacokinetic (PK) and pharmacodynamic (PD) parameters between formulations and dose levels after administration of 50- and 100-U subcutaneous doses of U-500R and U-100R insulins to healthy obese subjects; to assess safety and tolerability of the 2 treatments, at the respective doses, in healthy obese subjects. Study Design: Phase 1 (postmarketing), single-center, randomized, 4-period, 4-sequence crossover, investigator- and subject-blinded, euglycemic clamp study. Number of Subjects: Planned: 28 Randomized: 24 Completed: 21 Main Criteria for Inclusion: Healthy subjects, male or female, aged between 21 and 65 years, inclusive, with screening body mass index (BMI) 30 to 40 kg/m2, inclusive (weight 125 kg), participated in this study. Subjects who had a history of diabetes, impaired fasting glucose, or impaired glucose tolerance; significant cardiac, renal, gastrointestinal, or hepatic disease; chronic or recent exposure to glucocorticoid therapy; or known hypersensitivity or allergy to any of the study insulins or recipients of the study insulins were excluded. Test Product, Dose, and Mode of Administration: Human regular U-500 insulin (U-500R, 500 U/mL) at doses of 50 U and 100 U, given by subcutaneous injection on 2 different occasions according to randomized sequence. Reference Therapy, Dose, and Mode of Administration: Human regular U-100 insulin (U-100R, 100 U/mL) at doses of 50 U and 100 U, given by subcutaneous injection on 2 different occasions according to randomized sequence.

4 Return to list of studies Page 3 Duration of Treatment: Subjects were admitted and randomized to 1 of 4 sequences. Each sequence had a 4-period crossover. In each period, each subject received a single dose of 50 U or 100 U of either formulation of human regular insulin (U-500R or U-100R) and underwent a euglycemic clamp procedure for a period of up to 24 hours. There was a minimum and maximum interval of 7 and 21 days, respectively, between study periods. A follow-up visit was performed between 7 and 28 days after the subject s last dose of study medication. Variables: Bioanalytical: Blood samples were obtained during the euglycemic glucose clamp procedure for analysis of whole blood glucose to adjust glucose infusion rates to maintain euglycemia. Blood samples were collected for the determination of serum immunoreactive insulin (IRI) concentrations for up to 24 hours after dose administration. Pharmacokinetics: The PK parameters included area under the concentration-time curve from time zero to return to baseline (AUC0-t ), from time zero to the last time point with a measurable concentration (AUC0-tlast), maximum serum insulin concentration (Cmax), and the time to maximum insulin concentration (tmax). Pharmacodynamics: The PD parameters included the cumulative amount of glucose infused from dosing until clamp cessation (Gtot) and the maximum glucose infusion rate (Rmax). Other parameters included the time of maximum glucose infusion rate (trmax), time of half maximal glucose infusion rate before or after Rmax (early trmax50 or late trmax50), and times of first measured glucose infusion rate (tonset) and cessation of glucose infusion/clamp (trlast). Safety: Physical examination, vital signs, adverse event (AE) monitoring, and clinical laboratory testing. Evaluation Methods: Bioanalytical: Blood samples collected were analyzed immediately for whole blood glucose concentrations using an automated glucose analyzer. The serum concentrations of IRI were measured by a validated conventional competitive binding radioimmunoassay method. Pharmacokinetic: Pharmacokinetic parameters were evaluated by standard noncompartmental methods of PK analysis using PKS/WinNonlin Enterprise version Pharmacodynamic: Pharmacodynamic parameters were derived from the glucose clamp data using S-PLUS 7.0 Professional Developer (TIBCO software, Inc.). Statistical: The main PK and PD parameters (AUC0-t, Cmax, Gtot and Rmax) were log-transformed prior to analysis. The model included subject as a random effect, with period, sequence, and treatment as fixed effects. The estimated difference in tmax between the U-100 and U-500 groups for each of the doses together with the associated 90% confidence interval (CI) were analyzed using the nonparametric Wilcoxon signed-rank test. Analyses of trmax, early and late trmax50, tonset and trlast, were performed using similar linear mixed effects model without log-transforming the data. Safety: Summary statistics were tabulated for each safety parameter; AEs were listed and summarized. Summary: The current study was a Phase 1 (postmarketing), single-center, randomized, 4-period, 4-sequence crossover, investigator- and subject-blinded, euglycemic clamp study comparing PK and PD parameters of human regular U-100 (U-100R) insulin versus human regular insulin U-500 (U-500R) in healthy obese subjects. Of the 50 subjects who entered the study, 24 were randomly assigned to treatment and all 24 subjects received at least 1 dose of study drug; 21 subjects completed the study. Table IBHA.1 presents subject demographics.

5 Return to list of studies Page 4 Table IBHA.1. Patient Characteristics Enrolled N=24 Male n=14 Female n=10 Age range (y) 23 to 59 Primary Analysis: The primary objective of this study was to evaluate the relative exposure (the area under the IRI concentration versus time curve from time 0 to return to baseline [AUC0-t ]) for U-500R versus U-100R insulins after subcutaneous administration of a 50-U dose of each to healthy obese subjects; and to evaluate the relative exposure (AUC0-t ) for both formulations after administration of a 100-U dose. Overall insulin exposure, as assessed by AUC0-t, was not statistically significantly different between formulations at both the 50-U and 100-U doses. Other Pharmacokinetic Evaluations The U-500R peak insulin concentration (Cmax) was statistically significantly lower than that for U-100R at both doses. The time-to-peak insulin concentration (tmax) was statistically significantly longer for U-500R at the 100-U dose only. Pharmacodynamic Evaluations Overall effect (G tot ) for U-500R was not statistically significantly different from U-100R at both doses. Peak effect (R max ) was statistically significantly lower for U-500R versus U-100R at both doses. Time of peak effect (tr max ) was shown to be statistically significantly prolonged for U-500R versus U-100R at the 100-U dose only. Time variables reflective of duration of action (early and late tr max50, tr last ) were statistically significantly prolonged for U-500R versus U-100R at both doses. Table IBHA.2 presents PK and PD parameters.

6 Return to list of studies Table IBHA.2. Summary of Key Noncompartmental Pharmacokinetic and Pharmacodynamic Parameters [Geometric Mean (CV%)] of Immunoreactive Insulin Following Administration of 50 U and 100 U of U-100R and U-500R Insulin 90% CI U-100R (N=22) 6960 (27%) 50-U Dose Ratio ( ) or Difference U-500R ( ) of LS (N=21) Means 6430 (24%) 0.94 (0.88, 1.00) (22%) 809 (32%) 548 (22%) 0.69 (0.63, 0.75) 1400a (28%) 3.00 ( ) 4.00 ( ) 419 (28%) 628 (42%) 0.00 (0.00, 4.00) 3.00a ( ) (1.00,1.16) (0.80,0.96) 586 (23%) 966 (22%) PK Parameters U-100R (N=22) AUC0-t (pmol h/l) Cmax (pmol/l) tmax (h) Gtot (g) Rmax (mg/min) trmax (h) Early trmax50 (h) Late trmax50 (h) tonset (h) 387 (33%) 709 (50%) 621 (33%) 826 (37%) PD Parameters 6.17 (20%) 0.78 (0.11,1.45) 5.32 (22%) 6.37 (25%) 2.33 (40%) 0.68 (0.41,0.94) 1.51 (41%) 2.02 (59%) 14.1 (21%) 3.50 (2.64,4.37) 11.7 (16%) 15.1 (16%) (-0.10, 0.10) (78%) (77%) (96%) trlast (h) 18.3 (22%) 19.7 (18%) 1.38 (0.43, 2.34) 18.3 (15%) 21.5 (11%) Abbreviations: CI = confidence interval; CV = coefficient of variance; PD = pharmacodynamics; PK = pharmacokinetics; U = unit. Parameters are expressed as geometric means (CV%), except for tmax, expressed as median (range). a N=23; bn=24 *p<0.05; Ratio of LS means; Difference of LS means; Median difference 5.30 (25%) 1.69 (33%) 10.5 (25%) (64%) 100-U Dose Ratio ( ) or Difference U-500R ( ) of LS (N=23) Means (19%) 1020b 0.72 (31%) 8.00b 2.50 ( ) 90% CI (0.92, 1.05) (0.66, 0.78) (0.00, 4.00) (1.01, 1.17) (0.80, 0.95) (0.38, 1.70) (0.34, 0.87) (2.54, 4.25) (-0.06, 0.14) 3.24 (2.29, 4.19) Page 5

7 Return to list of studies Page 6 Safety: No death or serious adverse events occurred during this study. No subject discontinuation due to AE occurred during this study. The most common AEs were headache (17 instances reported by 12 subjects) and nausea (5 instances reported by 2 subjects). Most AEs were of mild or moderate severity. No clinically significant alterations in laboratory values were observed during the course of the study.

Sponsor / Company: Sanofi Drug substance(s): HOE901 (insulin glargine)

Sponsor / Company: Sanofi Drug substance(s): HOE901 (insulin glargine) These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):

More information

Sponsor. Novartis Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Investigational.

Sponsor. Novartis Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Investigational. Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Investigational Study Number CLAF237A2386 Title A single-center,

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Diabetes Care 34:2496 2501, 2011

Diabetes Care 34:2496 2501, 2011 Clinical Care/Education/Nutrition/Psychosocial Research O R I G I N A L A R T I C L E Pharmacokinetics and Pharmacodynamics of High-Dose Human Regular U-500 Insulin Versus Human Regular U-100 Insulin in

More information

NCT00272090. sanofi-aventis HOE901_3507. insulin glargine

NCT00272090. sanofi-aventis HOE901_3507. insulin glargine These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:

More information

2.0 Synopsis. Vicodin CR (ABT-712) M05-765 Clinical Study Report R&D/07/095. (For National Authority Use Only) to Part of Dossier: Volume:

2.0 Synopsis. Vicodin CR (ABT-712) M05-765 Clinical Study Report R&D/07/095. (For National Authority Use Only) to Part of Dossier: Volume: 2.0 Synopsis Abbott Laboratories Name of Study Drug: Vicodin CR Name of Active Ingredient: Hydrocodone/Acetaminophen Extended Release (ABT-712) Individual Study Table Referring to Part of Dossier: Volume:

More information

Solomon S. Steiner, Lutz Heinemann, Roderike Pohl, Frank Flacke, Andreas Pfützner, Patrick V. Simms, Marcus Hompesch. EASD September 18, 2007

Solomon S. Steiner, Lutz Heinemann, Roderike Pohl, Frank Flacke, Andreas Pfützner, Patrick V. Simms, Marcus Hompesch. EASD September 18, 2007 Pharmacokinetics and Pharmacodynamics of Insulin VIAject TM, Insulin Lispro and Regular Human Insulin When Injected Subcutaneously Immediately Before a Meal in Patients with Type 1 Diabetes. Solomon S.

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

SYNOPSIS. Risperidone: Clinical Study Report CR003274

SYNOPSIS. Risperidone: Clinical Study Report CR003274 SYNOPSIS Protocol No: CR003274 Title of Study: An Open-Label, Long-Term Trial of Risperidone Long-Acting Microspheres in the Treatment of Subjects Diagnosed with Schizophrenia Coordinating Investigator:

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational

Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational Clinical Trial Results Database Page 2 Sponsor Novartis Generic Drug Name Secukinumab Therapeutic Area of Trial Psoriasis Approved Indication investigational Clinical Trial Results Database Page 3 Study

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

A Peak at PK An Introduction to Pharmacokinetics

A Peak at PK An Introduction to Pharmacokinetics Paper IS05 A Peak at PK An Introduction to Pharmacokinetics Hannah Twitchett, Roche Products Ltd, Welwyn Garden City, UK Paul Grimsey, Roche Products Ltd, Welwyn Garden City, UK ABSTRACT The aim of this

More information

Active centers: 2. Number of patients/subjects: Planned: 20 Randomized: Treated: 20 Evaluated: Efficacy: 13 Safety: 20

Active centers: 2. Number of patients/subjects: Planned: 20 Randomized: Treated: 20 Evaluated: Efficacy: 13 Safety: 20 These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov

More information

Application for a Marketing Authorisation: Requirements and Criteria for the Assessment of QT Prolonging Potential

Application for a Marketing Authorisation: Requirements and Criteria for the Assessment of QT Prolonging Potential Application for a Marketing Authorisation: Requirements and Criteria for the Assessment of QT Prolonging Potential Bundesinstitut für Arzneimittel Dr. med. Clemens Mittmann Bundesinstitut für Arzneimittel

More information

Objective: To investigate the hepatic clearance of NRL972 in patients undergoing alcohol withdrawal therapy

Objective: To investigate the hepatic clearance of NRL972 in patients undergoing alcohol withdrawal therapy Title of the Study: A multi-centre, open, short term follow-up Phase II study to evaluate the clearance of NRL972 in patients undergoing alcohol withdrawal commencing in a controlled clinical setting Short

More information

Statistics and Pharmacokinetics in Clinical Pharmacology Studies

Statistics and Pharmacokinetics in Clinical Pharmacology Studies Paper ST03 Statistics and Pharmacokinetics in Clinical Pharmacology Studies ABSTRACT Amy Newlands, GlaxoSmithKline, Greenford UK The aim of this presentation is to show how we use statistics and pharmacokinetics

More information

Phase of development:

Phase of development: Title of study: A randomised, placebo-controlled, double-blind, double-dummy, four-way crossover, single-centre study to investigate the effects of 2 mg and 10 mg intravenously administered NRL972 on the

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website. It is provided for patients and healthcare professionals to increase the transparency of

More information

PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) STUDY IN THE ESTABLISHED STATUS EPILEPTICUS TREATMENT TRIAL. Lisa Coles, MS, PhD

PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) STUDY IN THE ESTABLISHED STATUS EPILEPTICUS TREATMENT TRIAL. Lisa Coles, MS, PhD PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) STUDY IN THE ESTABLISHED STATUS EPILEPTICUS TREATMENT TRIAL Lisa Coles, MS, PhD Key Personnel Personnel Institution Role James Cloyd, PharmD UMN Pharmacology

More information

GT-020 Phase 1 Clinical Trial: Results of Second Cohort

GT-020 Phase 1 Clinical Trial: Results of Second Cohort GT-020 Phase 1 Clinical Trial: Results of Second Cohort July 29, 2014 NASDAQ: GALT www.galectintherapeutics.com 2014 Galectin Therapeutics inc. Forward-Looking Statement This presentation contains, in

More information

Adaptive and Innovative Study Designs to Accelerate Drug Development from First-In- Human to First-In-Patient

Adaptive and Innovative Study Designs to Accelerate Drug Development from First-In- Human to First-In-Patient Adaptive and Innovative Study Designs to Accelerate Drug Development from First-In- Human to First-In-Patient Michelle L. Combs, PhD Vice President, Clinical Pharmacology Sciences Definition of Adaptive

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Questions and Answers for Health Care Providers: Renal Dosing and Administration Recommendations for Peramivir IV

Questions and Answers for Health Care Providers: Renal Dosing and Administration Recommendations for Peramivir IV Questions and Answers for Health Care Providers: Renal Dosing and Administration Recommendations for Peramivir IV The purpose of this document is to provide additional clarification to the existing information

More information

2. The prescribing clinician will register with the designated manufacturer.

2. The prescribing clinician will register with the designated manufacturer. Clozapine Management Program Description Magellan of Arizona Pharmacy Program Background: Magellan Health Services of Arizona recognizes the importance of a clozapine program. Clozapine received increased

More information

Sponsor Novartis Pharmaceuticals

Sponsor Novartis Pharmaceuticals Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name Indacaterol Therapeutic Area of Trial Chronic Obstructive Pulmonary Disease (COPD) Indication studied: COPD Study

More information

Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes

Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes U.S. Department of Health and Human Services Food and Drug Administration Center

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

More information

Adocia reports positive results from phase IIa clinical study of ultra-fast acting BioChaperone Lispro

Adocia reports positive results from phase IIa clinical study of ultra-fast acting BioChaperone Lispro PRESS RELEASE Adocia reports positive results from phase IIa clinical study of ultra-fast acting BioChaperone Lispro BioChaperone Lispro is significantly faster than Humalog in type I diabetic patients;

More information

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd.

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd. The Clinical Trial Protocol Guide 2011 BioStrategics Consulting Ltd. BioStrategics Consulting Ltd THE CLINICAL TRIAL PROTOCOL The clinical trial protocol to test one s product, to confirm or reject a specific

More information

CHAPTER V DISCUSSION. normal life provided they keep their diabetes under control. Life style modifications

CHAPTER V DISCUSSION. normal life provided they keep their diabetes under control. Life style modifications CHAPTER V DISCUSSION Background Diabetes mellitus is a chronic condition but people with diabetes can lead a normal life provided they keep their diabetes under control. Life style modifications (LSM)

More information

Summary ID# 13614. Clinical Study Summary: Study F3Z-JE-PV06

Summary ID# 13614. Clinical Study Summary: Study F3Z-JE-PV06 CT Registry ID# Page 1 Summary ID# 13614 Clinical Study Summary: Study F3Z-JE-PV06 INSIGHTS; INSulin-changing study Intending to Gain patients insights into insulin treatment with patient-reported Health

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Efficacy, safety and preference study of a insulin pen PDS290 vs. a Novo Nordisk marketed insulin pen in diabetics

Efficacy, safety and preference study of a insulin pen PDS290 vs. a Novo Nordisk marketed insulin pen in diabetics Efficacy, safety and preference study of a insulin pen PDS290 vs. a Novo Nordisk marketed insulin pen in diabetics This trial is conducted in the United States of America (USA). The aim of this clinical

More information

Clinical Trial Results Database Page 1

Clinical Trial Results Database Page 1 Clinical Trial Results Database Page Sponsor Novartis Generic Drug Name BGT6 Therapeutic Area of Trial Advanced solid malignancies Approved Indication Investigational Study Number CBGT6A0 Title A phase

More information

Letter Date March 27, 2007 Stamp Date March 28, 2007 PDUFA Goal Date January 28, 2008

Letter Date March 27, 2007 Stamp Date March 28, 2007 PDUFA Goal Date January 28, 2008 CLINICAL REVIEW Application Type NDA Submission Number 22-157 Submission Code Letter Date March 27, 2007 Stamp Date March 28, 2007 PDUFA Goal Date January 28, 2008 Reviewer Name Review Completion Date

More information

Sanofi Reports Positive Phase 3 Results for Toujeo (insulin glargine [rdna origin] injection, 300 U/mL)

Sanofi Reports Positive Phase 3 Results for Toujeo (insulin glargine [rdna origin] injection, 300 U/mL) PRESS RELEASE Sanofi Reports Positive Phase 3 Results for Toujeo (insulin glargine [rdna origin] injection, 300 U/mL) Meta-analysis of three late-stage trials in people with type 2 diabetes shows decreases

More information

Initiate Atorvastatin 20mg daily

Initiate Atorvastatin 20mg daily Type 2 Diabetes Patient Objectives Stopping Smoking BMI > 25 kg m² Control BP to

More information

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background:

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background: 1.0 Abstract Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA Keywords Rationale and Background: This abbreviated clinical study report is based on a clinical surveillance

More information

on behalf of the AUGMENT-HF Investigators

on behalf of the AUGMENT-HF Investigators One Year Follow-Up Results from AUGMENT-HF: A Multicenter Randomized Controlled Clinical Trial of the Efficacy of Left Ventricular Augmentation with Algisyl-LVR in the Treatment of Heart Failure* Douglas

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

If several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form.

If several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form. General Remarks This template of a data extraction form is intended to help you to start developing your own data extraction form, it certainly has to be adapted to your specific question. Delete unnecessary

More information

Does Diabetes Control Matter?

Does Diabetes Control Matter? Does Diabetes Control Matter? Laurence Kennedy, MD, FRCP Endocrinology Department Cleveland Clinic, OH Disclosures None Does Diabetes Control Matter? Generality of patients Relative Risk Complications

More information

Regulatory decision-making for the assessment of ECG effects of new drugs: Exposure-response analyis

Regulatory decision-making for the assessment of ECG effects of new drugs: Exposure-response analyis Regulatory decision-making for the assessment of ECG effects of new drugs: Exposure-response analyis Kevin M. Krudys, Ph.D. Team Leader Division of Pharmacometrics Office of Clinical Pharmacology 1 Disclosures

More information

CLINICAL STUDY REPORT SYNOPSIS

CLINICAL STUDY REPORT SYNOPSIS CLINICAL STUDY REPORT SYNOPSIS Document No.: EDMS-PSDB-6511351:2.0 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Protocol No.: CR002353 Johnson & Johnson Pharmaceutical

More information

Elements for a Public Summary

Elements for a Public Summary VI.2 Elements for a Public Summary VI.2.1 Overview of Disease Epidemiology Hunter syndrome is a rare genetic disease which mainly affects males of all ethnicities. The incidence rate ranges from 0.6 to

More information

U.S. Scientific Update Aricept 23 mg Tablets. Dr. Lynn Kramer President NeuroScience Product Creation Unit Eisai Inc.

U.S. Scientific Update Aricept 23 mg Tablets. Dr. Lynn Kramer President NeuroScience Product Creation Unit Eisai Inc. U.S. Scientific Update Aricept 23 mg Tablets Dr. Lynn Kramer President NeuroScience Product Creation Unit Eisai Inc. Unmet Need in Moderate to Severe Alzheimer s Disease (AD) Ongoing clinical deterioration

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Subcutaneous Immunoglobulin Replacement Therapy with Hizentra, the First 20% SCIG Preparation: a Practical Approach

Subcutaneous Immunoglobulin Replacement Therapy with Hizentra, the First 20% SCIG Preparation: a Practical Approach SUMMARY SLIDE Subcutaneous Immunoglobulin Replacement Therapy with Hizentra, the First 20% SCIG Preparation: a Practical Approach Benefits of SCIG administration compared with IVIG include: avoidance of

More information

GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8

GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 Current

More information

Medical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South

Medical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South Medical management of CHF: A New Class of Medication Al Timothy, M.D. Cardiovascular Institute of the South Disclosures Speakers Bureau for Amgen Background Chronic systolic congestive heart failure remains

More information

Harmony Clinical Trial Medical Media Factsheet

Harmony Clinical Trial Medical Media Factsheet Overview Harmony is the global Phase III clinical trial program for Tanzeum (albiglutide), a product developed by GSK for the treatment of type 2 diabetes. The comprehensive program comprised eight individual

More information

Not All Clinical Trials Are Created Equal Understanding the Different Phases

Not All Clinical Trials Are Created Equal Understanding the Different Phases Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact

More information

Evaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients

Evaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients Evaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients Jennifer Kuhns, Pharm.D. Pharmacy Practice Resident Children s Hospital of Michigan **The speaker has no actual or potential

More information

Module 5 Hypotheses Tests: Comparing Two Groups

Module 5 Hypotheses Tests: Comparing Two Groups Module 5 Hypotheses Tests: Comparing Two Groups Objective: In medical research, we often compare the outcomes between two groups of patients, namely exposed and unexposed groups. At the completion of this

More information

Bioequivalence Clinical Endpoint Studies

Bioequivalence Clinical Endpoint Studies Bioequivalence Clinical Endpoint Studies GPhA/FDA Fall Technical Conference Bethesda, MD, USA Oct. 29 2013 Murray P. Ducharme, PharmD, FCCP, FCP President and CEO, Learn and Confirm Inc. And, Professeur

More information

ICH Topic E 8 General Considerations for Clinical Trials. Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95)

ICH Topic E 8 General Considerations for Clinical Trials. Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95) European Medicines Agency March 1998 CPMP/ICH/291/95 ICH Topic E 8 General Considerations for Clinical Trials Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95) TRANSMISSION

More information

Diabetic nephropathy is detected clinically by the presence of persistent microalbuminuria or proteinuria.

Diabetic nephropathy is detected clinically by the presence of persistent microalbuminuria or proteinuria. Kidney Complications Diabetic Nephropathy Diabetic nephropathy is detected clinically by the presence of persistent microalbuminuria or proteinuria. The peak incidence of nephropathy is usually 15-25 years

More information

Efficacy and Safety of Insulin Aspart in Patients with Type 1 Diabetes Mellitus

Efficacy and Safety of Insulin Aspart in Patients with Type 1 Diabetes Mellitus Clin Pediatr Endocrinol 2002; 11(2), 87-92 Copyright 2002 by The Japanese Society for Pediatric Endocrinology Original Efficacy and Safety of Insulin Aspart in Patients with Type 1 Diabetes Mellitus Toshikazu

More information

Management of Diabetes in the Elderly. Sylvia Shamanna Internal Medicine (R1)

Management of Diabetes in the Elderly. Sylvia Shamanna Internal Medicine (R1) Management of Diabetes in the Elderly Sylvia Shamanna Internal Medicine (R1) Case 74 year old female with frontal temporal lobe dementia admitted for prolonged delirium and frequent falls (usually in the

More information

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C SR in Combination with an ERA and/or a PDE-5 Inhibitor

More information

The Economic Benefit of Public Funding of Insulin Pumps in Prince Edward Island

The Economic Benefit of Public Funding of Insulin Pumps in Prince Edward Island The Economic Benefit of Public Funding of Insulin Pumps in Prince Edward Island Executive Summary Every day, Prince Edward Islanders living with type 1 diabetes take insulin to live. Many deliver insulin

More information

Plasma Drug Concentration Time Profile Plotting Data

Plasma Drug Concentration Time Profile Plotting Data UNIT 2 PHARMACOKINETICS-BASIC CONSIDERATIONS Plasma Drug Concentration Time Profile Plotting Data S. SANGEETHA., M.PHARM., (Ph.d) Department of Pharmaceutics SRM College of Pharmacy SRM University INTRODUCTION

More information

Brief Communications. Awad Mohamed Ahmed, MD. Abstract

Brief Communications. Awad Mohamed Ahmed, MD. Abstract Awad Mohamed Ahmed, MD Professor of Medicine, University of Bahr Elghazal, Khartoum, Sudan For correspondence Professor Awad Mohamed Ahmed E-mail: awad.sd@gmail.com Tel.: +249 912344936 Abstract Randomized

More information

M4E(R2): The CTD Efficacy

M4E(R2): The CTD Efficacy M4E(R2): The CTD Efficacy This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for

More information

Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence

Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence 1.0 Abstract Title Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients with Psoriasis Severe or Moderate with Adalimumab Treatment (TOGETHER). Keywords Psoriasis,

More information

IMPROVED METABOLIC CONTROL WITH A FAVORABLE WEIGHT PROFILE IN PATIENTS WITH TYPE 2 DIABETES TREATED WITH INSULIN GLARGINE (LANTUS ) IN CLINICAL

IMPROVED METABOLIC CONTROL WITH A FAVORABLE WEIGHT PROFILE IN PATIENTS WITH TYPE 2 DIABETES TREATED WITH INSULIN GLARGINE (LANTUS ) IN CLINICAL 464 IMPROVED METABOLIC CONTROL WITH A FAVORABLE WEIGHT PROFILE IN PATIENTS WITH TYPE 2 DIABETES TREATED WITH INSULIN GLARGINE (LANTUS ) IN CLINICAL PRACTICE STEPHAN A SCHREIBER AND ANIKA RUßMAN ABSTRACT

More information

Hypoglycemia (Technician-Paramedic) Protocol revised October 2008

Hypoglycemia (Technician-Paramedic) Protocol revised October 2008 Hypoglycemia (Technician-Paramedic) Protocol revised October 2008 Preamble Prolonged hypoglycemia may result in serious neurologic complications and death. Glucose and glucagon can be administered to correct

More information

The Economic Benefit of Public Funding of Insulin Pumps in. New Brunswick

The Economic Benefit of Public Funding of Insulin Pumps in. New Brunswick The Economic Benefit of Public Funding of Insulin Pumps in New Brunswick Introduction Diabetes is a chronic, often debilitating and sometimes fatal disease, in which the body either cannot produce insulin

More information

NCT Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety,

NCT Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety, NCT02020291 Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of Foxy-5 in Patients with Metastatic Breast, Colon or Prostate

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium insulin glulisine for subcutaneous injection 100 units/ml (Apidra ) No. (298/06) Sanofi Aventis 4 August 2006 The Scottish Medicines Consortium (SMC) has completed its assessment

More information

Avastin in Metastatic Breast Cancer

Avastin in Metastatic Breast Cancer Non-interventional study Avastin in Metastatic Breast Cancer ML 21165 / 2007 Clinical Study Report Synopsis ROCHE ML21165 / WiSP Project RH09 / V. 1.0 / 24.06.2013 ROCHE ML21165-2 - Name of Sponsor Roche

More information

Learn More About Product Labeling

Learn More About Product Labeling Learn More About Product Labeling Product label The product label is developed during the formal process of review and approval by regulatory agencies of any medicine or medical product. There are specific

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Cancer Drug and Biological Products Clinical Data in Marketing Applications U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and

More information

New Evidence reports on presentations given at EULAR 2012. Rituximab for the Treatment of Rheumatoid Arthritis

New Evidence reports on presentations given at EULAR 2012. Rituximab for the Treatment of Rheumatoid Arthritis New Evidence reports on presentations given at EULAR 2012 Rituximab for the Treatment of Rheumatoid Arthritis Report on EULAR 2012 presentations Long-term safety of rituximab: 10-year follow-up in the

More information

The first endoscopically-delivered device therapy for obese patients with type 2 diabetes

The first endoscopically-delivered device therapy for obese patients with type 2 diabetes DIABETES WEIGHT ENDOBARRIER THERAPY The first endoscopically-delivered device therapy for obese patients with type 2 diabetes Restore the metabolic health of your patients with EndoBarrier Therapy. Dual

More information

REACH Risk Evaluation to Achieve Cardiovascular Health

REACH Risk Evaluation to Achieve Cardiovascular Health Dyslipidemia and type 1 diabetes mellitus History: A 15-year-old girl is seen in the endocrinology clinic for a routine follow-up visit for type 1 diabetes. She was diagnosed with diabetes at 12 years

More information

GENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2):

GENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2): Make copies of the blank SAE report form as needed. Retain originals with confirmation of all information faxed to DMID Pharmacovigilance Group Clinical Research Operations and Management Support (CROMS

More information

to Part of Dossier: Name of Active Ingredient: Title of Study: Quality of life study with adalimumab in rheumatoid arthritis. ESCALAR.

to Part of Dossier: Name of Active Ingredient: Title of Study: Quality of life study with adalimumab in rheumatoid arthritis. ESCALAR. 2.0 Synopsis Abbott Laboratories Name of Study Drug: Individual Study Table Referring to Part of Dossier: Adalimumab (HUMIRA) (For National Authority Use Only) Name of Active Ingredient: Adalimumab Title

More information

Understanding diabetes Do the recent trials help?

Understanding diabetes Do the recent trials help? Understanding diabetes Do the recent trials help? Dr Geoffrey Robb Consultant Physician and Diabetologist CMO RGA UK Services and Partnership Assurance AMUS 25 th March 2010 The security of experience.

More information

tips Insulin Pump Users 1 Early detection of insulin deprivation in continuous subcutaneous 2 Population Study of Pediatric Ketoacidosis in Sweden:

tips Insulin Pump Users 1 Early detection of insulin deprivation in continuous subcutaneous 2 Population Study of Pediatric Ketoacidosis in Sweden: tips Top International Publications Selection Insulin Pump Users Early detection of insulin deprivation in continuous subcutaneous insulin infusion-treated Patients with TD Population Study of Pediatric

More information

A pharmacist s guide to Pharmacy Services compensation

A pharmacist s guide to Pharmacy Services compensation Alberta Blue Cross Pharmaceutical Services A pharmacist s guide to Pharmacy Services compensation 83443 (2015/12) GENERAL DESCRIPTION... 3 Details... 3 ASSESSMENT CRITERIA... 3 Assessment for a Prescription

More information

嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯

嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯 The Clinical Efficacy and Safety of Sodium Glucose Cotransporter-2 (SGLT2) Inhibitors in Adults with Type 2 Diabetes Mellitus 嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯 Diabetes Mellitus : A group of diseases characterized

More information

Investigation of the effect of isomaltulose (PalatinoseTM) on metabolic parameters in subjects with Type 2 Diabetes.

Investigation of the effect of isomaltulose (PalatinoseTM) on metabolic parameters in subjects with Type 2 Diabetes. PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Investigation of the effect of isomaltulose (PalatinoseTM) on metabolic parameters in subjects with Type 2 Diabetes.

More information

BIOAVAILABILITY & BIOEQUIVALENCE TRIALS

BIOAVAILABILITY & BIOEQUIVALENCE TRIALS BIOAVAILABILITY & BIOEQUIVALENCE TRIALS Shubha Rani,, Ph.D. Technical Director & Head-Biometrics and Data Management Synchron Research Services Pvt. Ltd. Ahmedabad 380 054 drshubha@synchronresearch.com

More information

IV solutions may be given either as a bolus dose or infused slowly through a vein into the plasma at a constant or zero-order rate.

IV solutions may be given either as a bolus dose or infused slowly through a vein into the plasma at a constant or zero-order rate. د.شيماء Biopharmaceutics INTRAVENOUS INFUSION: IV solutions may be given either as a bolus dose or infused slowly through a vein into the plasma at a constant or zero-order rate. The main advantage for

More information

Guidance for Industry Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations

Guidance for Industry Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations Guidance for Industry Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations DRAFT GUIDANCE This guidance document is being distributed

More information

New anticoagulants: Monitoring or not Monitoring? Not Monitoring

New anticoagulants: Monitoring or not Monitoring? Not Monitoring The 2 nd World Congress on CONTROVERSIES IN HEMATOLOGY (COHEM) Barcelona, Spain September 6 8, 2012 New anticoagulants: Monitoring or not Monitoring? Not Monitoring Anna Falanga, MD Immunohematology and

More information

Main Effect of Screening for Coronary Artery Disease Using CT

Main Effect of Screening for Coronary Artery Disease Using CT Main Effect of Screening for Coronary Artery Disease Using CT Angiography on Mortality and Cardiac Events in High risk Patients with Diabetes: The FACTOR-64 Randomized Clinical Trial Joseph B. Muhlestein,

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. Current Step 4 version

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. Current Step 4 version INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL

More information

Cost-effectiveness of dimethyl fumarate (Tecfidera ) for the treatment of adult patients with relapsing remitting multiple sclerosis

Cost-effectiveness of dimethyl fumarate (Tecfidera ) for the treatment of adult patients with relapsing remitting multiple sclerosis Cost-effectiveness of dimethyl fumarate (Tecfidera ) for the treatment of adult patients with relapsing remitting multiple sclerosis The NCPE has issued a recommendation regarding the cost-effectiveness

More information

Draft presentation: Summary of product characteristics

Draft presentation: Summary of product characteristics Draft presentation: Summary of product characteristics What is it and what does it contain? Olayinka Fasanya Medical information - Information compliance and consistency An agency of the European Union

More information

Donovan Victorine Pharm.D. BCACP Clinical Pharmacy Specialist Boise VA Medical Center. U-500 Insulin

Donovan Victorine Pharm.D. BCACP Clinical Pharmacy Specialist Boise VA Medical Center. U-500 Insulin Donovan Victorine Pharm.D. BCACP Clinical Pharmacy Specialist Boise VA Medical Center U-500 Insulin Understand differences between U-500 concentrated insulin and standard insulin formulations Recognize

More information

Trial Description. Organizational Data. Secondary IDs

Trial Description. Organizational Data. Secondary IDs Trial Description Title A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar etanercept (GP2015) and Enbrel in patients

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Clinical trials preclinical requirements. Clinical trials - legislation

Clinical trials preclinical requirements. Clinical trials - legislation Clinical trials preclinical requirements Mikael Andersson, PhD Senior Expert Medical Products Agency, Sweden Tallinn 9/10 2009 Clinical trials - legislation Directive 2001/20/EC Clinical trial directive

More information

North of Tyne Area Prescribing Committee

North of Tyne Area Prescribing Committee North of Tyne Area Prescribing Committee ANTIPSYCHOTICS IN PSYCHOSIS, BIPOLAR DISORDER AND AUGMENTATION THERAPY IN TREATMENT RESISTANT DEPRESSION Information for Primary Care Updated November 2013 This

More information

Combined Diet and Physical Activity Promotion Programs to Prevent Type 2 Diabetes Among People at Increased Risk

Combined Diet and Physical Activity Promotion Programs to Prevent Type 2 Diabetes Among People at Increased Risk Combined Diet and Physical Activity Promotion s to Prevent Type 2 Diabetes Among People at Increased Risk Results of Comparative Studies of Combined Diet & Physical Activity vs. Categorical Outcomes Author,

More information

Developing Innovative Therapeutics for People with Orphan Liver Disease

Developing Innovative Therapeutics for People with Orphan Liver Disease Developing Innovative Therapeutics for People with Orphan Liver Disease PIPELINE PROGRESS AND FIRST QUARTER 2015 EARNINGS UPDATE NASDAQ: OCRX Forward-Looking Statements Certain statements in this presentation

More information