Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes

Size: px
Start display at page:

Download "Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes"

Transcription

1 Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period. Scientific Title Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: A 56 week randomised, double-blind, placebo-controlled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period Trial IDs and acronym(s) Novo Nordisk Trial ID NN Clinical Trials.gov Registration NCT Other Identifier(s) EudraCT Number: Other Identifier: U Condition Obesity Metabolism and nutrition disorder Trial dates Start date: 01.Jun.2011 Primary completion date: 01.Jan.2013 Completion date: 01.Jan.2013 Trial phase Phase 3 Treatment liraglutide placebo Arm Information with Assigned Treatment No. of arms: 3 Lira 3.0 mg (Experimental): Page 1

2 Drug: liraglutide Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks. Lira 1.8 mg (Experimental): Drug: liraglutide Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks. Placebo (Experimental): Drug: placebo Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks. Trial status Completed No. of trial participants 846 Age eligible for trial participation 18 Years and above Genders eligible for trial participation Both Inclusion criteria Informed consent obtained Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds HbA1c % (both inclusive) Body Mass Index (BMI) at least 27.0 kg/m^2 Stable body weight Preceding failed dietary effort Exclusion criteria Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months Known proliferative retinopathy or maculopathy History of acute or chronic pancreatitis Obesity induced by drug treatment Use of approved weight lowering pharmacotherapy Previous surgical treatment of obesity History of major depressive disorder or suicide attempt Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmhg and/or diastolic blood pressure above or equal to 100 mmhg) Screening calcitonin of 50 ng/l or above Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) Personal history of non-familial medullary thyroid carcinoma Page 2

3 Trial type Interventional Trial design Purpose: Treatment Allocation: Randomized Masking: Double blind Control: Placebo Control Assignment: Parallel Assignment Endpoint: Safety/Efficacy Study Primary outcome Change (%) from baseline in body weight (fasting) Proportion of subjects losing at least 5% of baseline body weight Proportion of subjects losing more than 10% of baseline body weight Secondary outcome(s) Change (%-points) from baseline in HbA1c (glycosylated haemoglobin A1c) Proportion of subjects reaching target HbA1c below 7% Proportion of subjects reaching target HbA1c below or equal to 6.5% Change from baseline in waist circumference Change (%) from baseline in body weight (fasting) Time frame: Week 0, week 68 Change (%) from week 56 to 68 in body weight (fasting) Time frame: Week 56, week 68 Change from baseline in waist circumference Time frame: Week 0, week 68 Change from week 56 to 68 in waist circumference Time frame: Week 56, week 68 Incidence of hypoglycaemic episodes Time frame: Weeks 0-56 Participating countries France: Completed Germany: Completed Israel: Completed South Africa: Completed Spain: Completed Sweden: Completed Turkey: Completed United Kingdom: Completed United States: Completed Health authority approval obtained from Page 3

4 France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Israel: Israeli Health Ministry Pharmaceutical Administration South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Central contact information Trial sponsored by: Novo Nordisk A/S Contact: For trials conducted in the US: (+1) Study director Name: Global Clinical Registry (GCR, 1452) Novo Nordisk affiliation: Novo Nordisk A/S Scientific trial publications Liraglutide 3.0 mg for weight management in obese/overweight adults with type 2 diabetes: Results from the SCALE Diabetes 56-week randomized, double-blind, placebo-controlled trial. Diabetes 2014; (Suppl 1) (63): Abstract 97-OR Ard J, Cannon A, Lewis C E, Lofton H, Vang Skjøth T, Stevenin B, Pi-Sunyer X. The efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: Subgroup analysis across SCALE and phase 2 randomized trials. Diabetes, obesity & metabolism 2016; Davies Melanie J, Bergenstal Richard, Bode Bruce, Kushner Robert F, Lewin Andrew, Skjøth Trine Vang, Andreasen Arne Haahr, Jensen Christine Bjørn, DeFronzo Ralph A. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA 2015; 314 (7): McEvoy Bradley W. Missing data in clinical trials for weight management. Journal of biopharmaceutical statistics 2015; Wilding J P H, Overgaard R V, Jacobsen L Vestergård, Jensen Christine Bjørn, le Roux Carel W. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes, obesity & metabolism 2016; Labeling information EU: url=menus/medicines/medicines.jsp&mid=wc0b01ac058001d125 US: Information provided by Novo Nordisk A/S Protocol Information Published: 06.Jan.2011 Protocol Information Last Updated: 07.Apr Page 4

5 PDF generation date: 13.Jul Page 5

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE - Obesity and Prediabetes

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE - Obesity and Prediabetes Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE - Obesity and Prediabetes This trial is conducted in Africa, Asia, Europe, Oceania,

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

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

GLP-1 Receptor Agonists (Byetta /Victoza ) Step Therapy Criteria

GLP-1 Receptor Agonists (Byetta /Victoza ) Step Therapy Criteria GLP-1 Receptor Agonists (Byetta /Victoza ) Step Therapy Criteria Brand Generic Dosage Form Byetta exenatide subcutaneous injection Victoza liraglutide subcutaneous injection PROGRAM OBJECTIVES The intent

More information

SHORT CLINICAL GUIDELINE SCOPE

SHORT CLINICAL GUIDELINE SCOPE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SHORT CLINICAL GUIDELINE SCOPE 1 Guideline title Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes 1.1 Short title Type 2

More information

Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety

Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety Anders Svensson MD, PhD Head of Global Clinical Development Metabolism, F Hoffmann LaRoche Ltd. Basel, Switzerland Overview of

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

linagliptin, 5mg film-coated tablet (Trajenta ) SMC No. (746/11) Boehringer Ingelheim / Eli Lilly and Company Ltd

linagliptin, 5mg film-coated tablet (Trajenta ) SMC No. (746/11) Boehringer Ingelheim / Eli Lilly and Company Ltd linagliptin, 5mg film-coated tablet (Trajenta ) SMC No. (746/11) Boehringer Ingelheim / Eli Lilly and Company Ltd 09 December 2011 The Scottish Medicines Consortium (SMC) has completed its assessment of

More information

NDA 206321 SAXENDA (liraglutide [rdna origin] injection) Novo Nordisk Inc. 800 Scudders Mill Road, Plainsboro, NJ 08536 Phone: 609-786-4690

NDA 206321 SAXENDA (liraglutide [rdna origin] injection) Novo Nordisk Inc. 800 Scudders Mill Road, Plainsboro, NJ 08536 Phone: 609-786-4690 Initial REMS approval: 12/2014 NDA 206321 SAXENDA (liraglutide [rdna origin] injection) Novo Nordisk Inc. 800 Scudders Mill Road, Plainsboro, NJ 08536 Phone: 609-786-4690 RISK EVALUATION AND MITIGATION

More information

The Correlation Between Blood omega3 and ADHD

The Correlation Between Blood omega3 and ADHD The Correlation Between Blood omega3 and ADHD This study is not yet open for participant recruitment. (see Contacts and Locations) Verified March 2015 by Ziv Hospital Sponsor: Ayelet Omer Armon Information

More information

CASE B1. Newly Diagnosed T2DM in Patient with Prior MI

CASE B1. Newly Diagnosed T2DM in Patient with Prior MI Newly Diagnosed T2DM in Patient with Prior MI 1 Our case involves a gentleman with acute myocardial infarction who is newly discovered to have type 2 diabetes. 2 One question is whether anti-hyperglycemic

More information

ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes

ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes Effects of a fixed combination of the ACE inhibitor, perindopril,

More information

Liraglutide for the treatment of type 2 diabetes

Liraglutide for the treatment of type 2 diabetes DOI: 10.3310/hta15suppl1/09 Health Technology Assessment 2011; Vol. 15: Suppl. 1 77 Liraglutide for the treatment of type 2 diabetes D Shyangdan, 1 * E Cummins, 2 P Royle 1 and N Waugh 1 1 Department of

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

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

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research Institute University of Miami Miller

More information

Understanding Diseases and Treatments with Canadian Real-world Evidence

Understanding Diseases and Treatments with Canadian Real-world Evidence Understanding Diseases and Treatments with Canadian Real-world Evidence Real-World Evidence for Successful Market Access WHITEPAPER REAL-WORLD EVIDENCE Generating real-world evidence requires the right

More information

NEW CLASS OF TREATMENT FOR OVERACTIVE BLADDER DEMONSTRATES EFFICACY AND TOLERABILITY ACROSS THREE SEPARATE STUDIES

NEW CLASS OF TREATMENT FOR OVERACTIVE BLADDER DEMONSTRATES EFFICACY AND TOLERABILITY ACROSS THREE SEPARATE STUDIES NEW CLASS OF TREATMENT FOR OVERACTIVE BLADDER DEMONSTRATES EFFICACY AND TOLERABILITY ACROSS THREE SEPARATE STUDIES Paris, February 24th 2012. ASTELLAS PHARMA EUROPE Ltd., European subsidiary of Tokyo-based

More information

Jill Malcolm, Karen Moir

Jill Malcolm, Karen Moir Evaluation of Fife- DICE: Type 2 diabetes insulin conversion Article points 1. Fife-DICE is an insulin conversion group education programme. 2. People with greater than 7.5% on maximum oral therapy are

More information

Guideline on clinical evaluation of medicinal products used in weight management

Guideline on clinical evaluation of medicinal products used in weight management 23 June 2016 Committee for Medicinal Products for Human Use (CHMP) Guideline on clinical evaluation of medicinal products used in weight management Draft agreed by Cardiovascular Working Party 26 March

More information

Clinical Research on Lifestyle Interventions to Treat Obesity and Asthma in Primary Care Jun Ma, M.D., Ph.D.

Clinical Research on Lifestyle Interventions to Treat Obesity and Asthma in Primary Care Jun Ma, M.D., Ph.D. Clinical Research on Lifestyle Interventions to Treat Obesity and Asthma in Primary Care Jun Ma, M.D., Ph.D. Associate Investigator Palo Alto Medical Foundation Research Institute Consulting Assistant

More information

Workshop A Tara Kadis

Workshop A Tara Kadis Workshop A Tara Kadis Considerations/barriers in decision making about insulin verses GLP-1 use in people with type 2 diabetes Which Insulin regimes should we consider? Diabetes is a progressive multi-system

More information

Insulin or GLP1 How to make this choice in Practice. Tara Kadis Lead Nurse - Diabetes & Endocrinology Mid Yorkshire Hospitals NHS Trust

Insulin or GLP1 How to make this choice in Practice. Tara Kadis Lead Nurse - Diabetes & Endocrinology Mid Yorkshire Hospitals NHS Trust Insulin or GLP1 How to make this choice in Practice Tara Kadis Lead Nurse - Diabetes & Endocrinology Mid Yorkshire Hospitals NHS Trust Workshop Over View Considerations/barriers to treatments in type 2

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

Prevalence and Characteristics of Low Serum Testosterone Levels in Men with Type 2 Diabetes Mellitus Naïve to Injectable Therapy

Prevalence and Characteristics of Low Serum Testosterone Levels in Men with Type 2 Diabetes Mellitus Naïve to Injectable Therapy Prevalence and Characteristics of Low Serum Testosterone Levels in Men with Type 2 Diabetes Mellitus Naïve to Injectable Therapy International Society for Sexual Medicine 2014 Presenter: Felipe Borges

More information

REF/2011/03/002226 CTRI Website URL - http://ctri.nic.in

REF/2011/03/002226 CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 14 Jul 2016 15:20:58 GMT) CTRI Number Last Modified On 28/01/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

Research Study Protocol Template

Research Study Protocol Template Research Study Protocol Template (For clinical trials) Instructions This protocol template is a tool to facilitate the development of a research study protocol specifically designed for the investigator

More information

Diabetes and Obesity in Women of Childbearing Age. Dr Ketan Dhatariya Consultant in Diabetes and Endocrinology, NNUH

Diabetes and Obesity in Women of Childbearing Age. Dr Ketan Dhatariya Consultant in Diabetes and Endocrinology, NNUH Diabetes and Obesity in Women of Childbearing Age Dr Ketan Dhatariya Consultant in Diabetes and Endocrinology, NNUH A Few Perceptions What causes obesity? Your lifestyle has changed thus you have put on

More information

Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide)

Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide) EMA/467911/2014 Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide) This is a summary of the risk management plan (RMP) for Xultophy, which details the measures to be

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

Measuring and Improving the Quality of Diabetes care in General Practice. Dr M Grixti. Dr C Scalpello, Dr C Mercieca, Dr P Mangion, Dr T O Sullivan

Measuring and Improving the Quality of Diabetes care in General Practice. Dr M Grixti. Dr C Scalpello, Dr C Mercieca, Dr P Mangion, Dr T O Sullivan Measuring and Improving the Quality of Diabetes care in General Practice Dr M Grixti. Dr C Scalpello, Dr C Mercieca, Dr P Mangion, Dr T O Sullivan Outline of presentation Statistics Diabetes care,as the

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

Insulin Degludec (Type 2 Diabetes) - Analysis and Forecasts to 2020

Insulin Degludec (Type 2 Diabetes) - Analysis and Forecasts to 2020 Brochure More information from http://www.researchandmarkets.com/reports/2075322/ Insulin Degludec (Type 2 Diabetes) - Analysis and Forecasts to 2020 Description: Insulin Degludec (Type 2 Diabetes) Analysis

More information

Which drugs should be used to treat diabetes in cirrhotic patients?

Which drugs should be used to treat diabetes in cirrhotic patients? Which drugs should be used to treat diabetes in cirrhotic patients? Frankfurt am Main 10-12 September 2015 Jörg Bojunga Medizinische Klinik I Johann Wolfgang Goethe-Universität Frankfurt am Main Significance

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

2. Background This drug had not previously been considered by the PBAC.

2. Background This drug had not previously been considered by the PBAC. PUBLIC SUMMARY DOCUMENT Product: Ambrisentan, tablets, 5 mg and 10 mg, Volibris Sponsor: GlaxoSmithKline Australia Pty Ltd Date of PBAC Consideration: July 2009 1. Purpose of Application The submission

More information

Do we need alternative routes of insulin administration (inhaled insulin) in Type 2 diabetes? Cons: Suad Efendic Karolinska Institutet, Sweden

Do we need alternative routes of insulin administration (inhaled insulin) in Type 2 diabetes? Cons: Suad Efendic Karolinska Institutet, Sweden Do we need alternative routes of insulin administration (inhaled insulin) in Type 2 diabetes? Cons: Suad Efendic Karolinska Institutet, Sweden The Diabetes Management Situation Today Diabetes is a growing

More information

REF/2011/08/ CTRI Website URL -

REF/2011/08/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 23 Jul 2016 17:36:46 GMT) CTRI Number Last Modified On 21/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

CLINICAL PRACTICE GUIDELINE

CLINICAL PRACTICE GUIDELINE CLINICAL PRACTICE GUIDELINE Procedure: Diabetes Guideline Review Cycle: Biennial Reviewed By: Amish Purohit, MD, MHA, CPE, FACHE Review Date: November 2014 Committee Approval Date: 11/12/2014 PURPOSE:

More information

A Study To Evaluate PF With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

A Study To Evaluate PF With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome A service of the U.S. National Institutes of Health Trial record 1 of 5 for: efficacy of PF-04449913 Previous Study Return to List Next Study A Study To Evaluate PF-04449913 With Chemotherapy In Patients

More information

New Medicine Recommendations Albiglutide (Eperzan ) and Dulaglutide (Trulicity ) For Type II Diabetes Mellitus

New Medicine Recommendations Albiglutide (Eperzan ) and Dulaglutide (Trulicity ) For Type II Diabetes Mellitus New Medicine Recommendations Albiglutide (Eperzan ) and Dulaglutide (Trulicity ) For Type II Diabetes Mellitus Albiglutide: Black Albiglutide is NOT recommended for use by the NHS in Lancashire. Data from

More information

Second- and Third-Line Approaches for Type 2 Diabetes Workgroup: Topic Brief

Second- and Third-Line Approaches for Type 2 Diabetes Workgroup: Topic Brief Second- and Third-Line Approaches for Type 2 Diabetes Workgroup: Topic Brief March 7, 2016 Session Objective: The objective of this workshop is to assess the value of undertaking comparative effectiveness

More information

East Anglian Retinal Society An Introduction to and Update in Diabetes

East Anglian Retinal Society An Introduction to and Update in Diabetes East Anglian Retinal Society An Introduction to and Update in Diabetes Dr Ketan Dhatariya MBBS MSc MD MS FRCP Consultant in Diabetes and Endocrinology Norfolk and Norwich University Hospital NHS Trust

More information

The Effect of the Change in the Definition of Type 2 Diabetes on Patient Demographics

The Effect of the Change in the Definition of Type 2 Diabetes on Patient Demographics Int J Endocrinol Metab 2009;2: 51-55 The Effect of the Change in the Definition of Type 2 Diabetes on Patient Demographics ORIGINAL ARTICLE Tildesley HD a,b, Wise JS b, Mazanderani AB a, Aydin CA b, Fraser

More information

Comparing Medications for Adults With Type 2 Diabetes Focus of Research for Clinicians

Comparing Medications for Adults With Type 2 Diabetes Focus of Research for Clinicians Clinician Research Summary Diabetes Type 2 Diabetes Comparing Medications for Adults With Type 2 Diabetes Focus of Research for Clinicians A systematic review of 166 clinical studies published between

More information

University of Warwick institutional repository:

University of Warwick institutional repository: University of Warwick institutional repository: http://go.warwick.ac.uk/wrap This paper is made available online in accordance with publisher policies. Please scroll down to view the document itself. Please

More information

trends in the treatment of Diabetes type 2 - New classes of antidiabetic drugs. IAIM, 2015; 2(4): 223-

trends in the treatment of Diabetes type 2 - New classes of antidiabetic drugs. IAIM, 2015; 2(4): 223- Review Article Pharmacological trends in the treatment of Diabetes type 2 - New classes of antidiabetic Silvia Mihailova 1*, Antoaneta Tsvetkova 1, Anna Todorova 2 1 Assistant Pharmacist, Education and

More information

Diabetes Subcommittee of PTAC meeting. held 18 June 2008. (minutes for web publishing)

Diabetes Subcommittee of PTAC meeting. held 18 June 2008. (minutes for web publishing) Diabetes Subcommittee of PTAC meeting held 18 June 2008 (minutes for web publishing) Diabetes Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology and Therapeutics

More information

abcdefghijklmnopqrstu

abcdefghijklmnopqrstu The Quality Unit Planning and Quality Division E: sara.davies@scotland.gsi.gov.uk Heather.knox@nhs.net T: 0131-244 2287 abcdefghijklmnopqrstu NHSScotland Board Chief Executives NHSScotland Board Medical

More information

Effect of Exercise on BMI and Biochemical Profile of Selected Obese Diabetic Women

Effect of Exercise on BMI and Biochemical Profile of Selected Obese Diabetic Women Effect of Exercise on BMI and Biochemical Profile of Selected Obese Diabetic Women Nazni, P. *, Poongodi Vijayakumar, T. ** & Angamuthu, K. *** * Lecturer, Department of Food Science, Periyar University,

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Pre-Authorisation Evaluation of Medicines for Human Use London, 24 July 2008 Doc. Ref. EMEA/CHMP/EWP/517497/2007 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE

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

Kardiovaskulär säkerhet vid behandling av typ 2-diabetes Vad säger senaste data?

Kardiovaskulär säkerhet vid behandling av typ 2-diabetes Vad säger senaste data? Kardiovaskulär säkerhet vid behandling av typ 2-diabetes Vad säger senaste data? Michael Alvarsson Kliniken för Endokrinologi, Metabolism och Diabetes Karolinska Universitetssjukhuset Solna Near-normal

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

Which diet is best for managing Type 2 Diabetes? Dr Rob Andrews Consultant Senior lecturer University of Bristol / Taunton NHS trust

Which diet is best for managing Type 2 Diabetes? Dr Rob Andrews Consultant Senior lecturer University of Bristol / Taunton NHS trust Taunton and Somerset NHS foundation trust NHS Which diet is best for managing Type 2 Diabetes? Dr Rob Andrews Consultant Senior lecturer University of Bristol / Taunton NHS trust If people let government

More information

Plantabetics Dietary supplement for dietetic treatment of diabetes mellitus type 2

Plantabetics Dietary supplement for dietetic treatment of diabetes mellitus type 2 Plantabetics Dietary supplement for dietetic treatment of diabetes mellitus type 2 Clinical study on efficacy and safety of Plantabetics according to GCP guidelines Protokoll ID : Trial register number:

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

Nutrition. Type 2 Diabetes: A Growing Challenge in the Healthcare Setting NAME OF STUDENT

Nutrition. Type 2 Diabetes: A Growing Challenge in the Healthcare Setting NAME OF STUDENT 1 Nutrition Type 2 Diabetes: A Growing Challenge in the Healthcare Setting NAME OF STUDENT 2 Type 2 Diabetes: A Growing Challenge in the Healthcare Setting Introduction and background of type 2 diabetes:

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

UNIVERSITY OF MEDICINE AND PHARMACY CRAIOVA DOCTORAL SCHOOL DOCTORATE THESIS. - Summary

UNIVERSITY OF MEDICINE AND PHARMACY CRAIOVA DOCTORAL SCHOOL DOCTORATE THESIS. - Summary UNIVERSITY OF MEDICINE AND PHARMACY CRAIOVA DOCTORAL SCHOOL DOCTORATE THESIS - Summary CHRONIC COMPLICATIONS IN PATIENTS WITH TYPE 1 DIABETES MELLITUS - Epidemiological study - PhD Manager: Professor PhD.

More information

Strengthening the Pharmacist Skills in Managing Diabetes Practice Based Program 27 Contact Hours

Strengthening the Pharmacist Skills in Managing Diabetes Practice Based Program 27 Contact Hours Strengthening the Pharmacist Skills in Managing Diabetes Practice Based Program 27 Contact Hours Presented by New York State Council of Health system Pharmacists October 18 19, 2013 St. John s University,

More information

Finding weight loss strategies that work in primary care

Finding weight loss strategies that work in primary care Finding weight loss strategies that work in primary care Article: Wilson C. Obesity: Finding weight loss strategies that work in primary care. Nat Rev Endocrinol. 2013;9(3):126. Review: In this Research

More information

Trends in Prescribing of Drugs for Type 2 Diabetes in General Practice in England (Chart 1) Other intermediate and long-acting insulins

Trends in Prescribing of Drugs for Type 2 Diabetes in General Practice in England (Chart 1) Other intermediate and long-acting insulins Type 2 Diabetes Type 2 diabetes is the most common form of diabetes, accounting for 90 95% of cases. 1 Charts 1 and 2 reflect the effect of increasing prevalence on prescribing and costs of products used

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

Treating Patients with PRE-DIABETES David Doriguzzi, PA-C First Valley Medical Group. Learning Objectives. Background. CAPA 2015 Annual Conference

Treating Patients with PRE-DIABETES David Doriguzzi, PA-C First Valley Medical Group. Learning Objectives. Background. CAPA 2015 Annual Conference Treating Patients with PRE-DIABETES David Doriguzzi, PA-C First Valley Medical Group Learning Objectives To accurately make the diagnosis of pre-diabetes/metabolic syndrome To understand the prevalence

More information

Type 2 Diabetes workshop notes

Type 2 Diabetes workshop notes Group 1 notes Abi / Nicole Type 2 Diabetes workshop notes 4.1 Population The group discussed the following sub groups that may need addressing: Men-as they tend to die earlier compared with women, their

More information

Riociguat Clinical Trial Program

Riociguat Clinical Trial Program Riociguat Clinical Trial Program Riociguat (BAY 63-2521) is an oral agent being investigated as a new approach to treat chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension

More information

Update on diabetes care and therapy. Tunde Peto Head of Reading Centre

Update on diabetes care and therapy. Tunde Peto Head of Reading Centre Update on diabetes care and therapy Tunde Peto Head of Reading Centre Case 1: 39 year old male, works as bricklayer Type 1 diabetes diagnosed 29 years ago BMI: 27 kg/m HbA1c: 8.5% Cholesterol: 6 mmol/l

More information

Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators

Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators Shaikha Al Naimi Doctor of Pharmacy Student College of Pharmacy Qatar University

More information

Clinical Study Report Synopsis. A psoriasis plaque test trial with LP0113 spray in patients with psoriasis vulgaris

Clinical Study Report Synopsis. A psoriasis plaque test trial with LP0113 spray in patients with psoriasis vulgaris This document has been downloaded from \VW'\V.leo-pharma.com subject to the terms of use state on the website. It contains data and results regarding approved and non-approved uses, formulations or treatment

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

Glucagon-like peptide-1 analogs in the treatment of Type 2 diabetes: a review of the Phase II and III trials

Glucagon-like peptide-1 analogs in the treatment of Type 2 diabetes: a review of the Phase II and III trials Review: Clinical Trial Outcomes Glucagon-like peptide-1 analogs in the treatment of Type 2 diabetes: a review of the Phase II and III trials Clin. Invest. (2011) 1(2), 327 343 Glucagon-like peptide-1 (GLP-1)

More information

from 5 September 2013

from 5 September 2013 Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII - Resolutions on the benefit assessment of pharmaceuticals with new active ingredients, in

More information

Insulin myths and facts

Insulin myths and facts london medicines evaluation network Insulin myths and facts Statement 1 Insulin is the last resort for patients with Type 2 diabetes After initial metformin and sulfonylurea therapy, NICE and SIGN suggest

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

Oral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial

Oral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial Oral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial Marcus R. Pereira A. Study Purpose Hepatic encephalopathy is a common complication

More information

Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients with Multiple Sclerosis

Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients with Multiple Sclerosis Your contact News Release Barbara Fry Phone +1 905 919 0163 April 29/30, 2009 Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients with Multiple

More information

Prevention of and the Screening for Diabetes Part I Insulin Resistance By James L. Holly, MD Your Life Your Health The Examiner January 19, 2012

Prevention of and the Screening for Diabetes Part I Insulin Resistance By James L. Holly, MD Your Life Your Health The Examiner January 19, 2012 Prevention of and the Screening for Diabetes Part I Insulin Resistance By James L. Holly, MD Your Life Your Health The Examiner January 19, 2012 In 2002, SETMA began a relationship with Joslin Diabetes

More information

ESCMID Online Lecture Library. by author

ESCMID Online Lecture Library. by author Do statins improve outcomes of patients with sepsis and pneumonia? Jordi Carratalà Department of Infectious Diseases Statins for sepsis & community-acquired pneumonia Sepsis and CAP are major healthcare

More information

Evaluation of: The Local Enhanced Service provision of for Managing Diabetes Injectable Therapies

Evaluation of: The Local Enhanced Service provision of for Managing Diabetes Injectable Therapies Evaluation of: The Local Enhanced Service provision of for Managing Diabetes Injectable Therapies Two CCGs have asked the WSYBCSU to evaluate the current Local Enhanced Service (LES) provision in this

More information

PEER REVIEW HISTORY ARTICLE DETAILS

PEER REVIEW HISTORY ARTICLE DETAILS PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Clinical Trials Glossary

Clinical Trials Glossary Clinical Trials Glossary ADME: an acronym for absorption, distribution, metabolism and elimination. ADME studies determine how a drug is absorbed by the body, the chemical changes that it may undergo and

More information

Why do we Need an Artificial Pancreas?

Why do we Need an Artificial Pancreas? Pediatric Diabetes in the US 2013 Why do we Need an Artificial Pancreas? Georgeanna J Klingensmith, MD Barbara Davis Center Georgeanna Keystone J Klingensmith, 2010 MD Barbara Davis Center Keystone 2013

More information

Type 2 Diabetes. Tabinda Dugal GP Day 4/05/16

Type 2 Diabetes. Tabinda Dugal GP Day 4/05/16 Type 2 Diabetes Tabinda Dugal GP Day 4/05/16 Diabetes Diabetes.a growing health crisis in Britain 869m per year 10% of NHS budget Projections.. 5 million by 2025 Youngest patient? T2DM Type 2 diabetes

More information

DIABETES FACT SHEET IN KOREA 2013

DIABETES FACT SHEET IN KOREA 2013 DIABETES FACT SHEET IN KOREA 2013 DIABETES FACT SHEET IN KOREA 2013 SUMMARY Among adults aged 30 years and older, about 4 million Koreans (12.4%) had diabetes in 2011. 20% of Korean adults were diagnosed

More information

Participating in Alzheimer s Disease Clinical Trials and Studies

Participating in Alzheimer s Disease Clinical Trials and Studies Participating in Alzheimer s Disease Clinical Trials and Studies FACT SHEET When Margaret was diagnosed with earlystage Alzheimer s disease at age 68, she wanted to do everything possible to combat the

More information

Ask Us About Clinical Trials

Ask Us About Clinical Trials Ask Us About Clinical Trials Clinical Trials and You. Our specialists and researchers are at the forefront of their fields and are leading the way in developing new therapies and procedures for diagnosing

More information

YOUR GUIDE TO. Lowering The Risk of Heart Attack and Stroke

YOUR GUIDE TO. Lowering The Risk of Heart Attack and Stroke YOUR GUIDE TO Lowering The Risk of Heart Attack and Stroke The Mercy Health Heart Institute team is focused on helping you keep your heart healthy. As part of this effort, it s important for you to know

More information

Clinical Study Report Synopsis

Clinical Study Report Synopsis Clinical Study Report Synopsis A Phase 1, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults with Mild to Moderate Atopic

More information

Comparative Review of Oral Hypoglycemic Agents in Adults

Comparative Review of Oral Hypoglycemic Agents in Adults SECTION 18.5 Comparative Review of Oral Hypoglycemic Agents in Adults Harinder Chahal For WHO Secretariat Table of Contents Acronyms:... 3 I. Background and Rationale for the review:... 4 II. Medications

More information

Slide 1. Obesity market update and Saxenda performance. Christian Kanstrup SVP Marketing, Medical Affairs and Stakeholder Engagement

Slide 1. Obesity market update and Saxenda performance. Christian Kanstrup SVP Marketing, Medical Affairs and Stakeholder Engagement Slide 1 Obesity market update and Saxenda performance Christian Kanstrup SVP Marketing, Medical Affairs and Stakeholder Engagement Obesity market update and Saxenda performance Slide 2 Forward-looking

More information

Blood Pressure Classification. Blood Pressure Classification

Blood Pressure Classification. Blood Pressure Classification Blood Pressure Classification Blood Pressure Classification BP Classification SBP mmhg DBP mmhg Normal

More information

Cochrane Quality and Productivity topics

Cochrane Quality and Productivity topics Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus NICE has developed the Cochrane Quality and Productivity (QP) topics to help the NHS identify practices

More information

About the RECORD Clinical Trial Program

About the RECORD Clinical Trial Program About the RECORD Clinical Trial Program Fast facts RECORD was a global program of four trials in more than 12,500 patients, comparing Xarelto (rivaroxaban) and enoxaparin in the prevention of venous thromboembolism

More information

Correspondence should be addressed to Farid Saad; farid.saad@bayer.com

Correspondence should be addressed to Farid Saad; farid.saad@bayer.com International Journal of Endocrinology, Article ID 683515, 15 pages http://dx.doi.org/10.1155/2014/683515 Clinical Study Effects of Long-Term Testosterone Therapy on Patients with Diabesity : Results of

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Afrezza Page 1 of 6 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Afrezza (human insulin) Prime Therapeutics will review Prior Authorization requests Prior Authorization

More information

TYPE 2 DIABETES MELLITUS: NEW HOPE FOR PREVENTION. Robert Dobbins, M.D. Ph.D.

TYPE 2 DIABETES MELLITUS: NEW HOPE FOR PREVENTION. Robert Dobbins, M.D. Ph.D. TYPE 2 DIABETES MELLITUS: NEW HOPE FOR PREVENTION Robert Dobbins, M.D. Ph.D. Learning Objectives Recognize current trends in the prevalence of type 2 diabetes. Learn differences between type 1 and type

More information

Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872]

Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872] For public handouts Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872] 1 st Appraisal Committee meeting Clinical Effectiveness and

More information

Diabetes Medications in CKD. Dr Adam White, MD FRCPC Endocrinology and Metabolism UBC and SPH Division of Endocrinology

Diabetes Medications in CKD. Dr Adam White, MD FRCPC Endocrinology and Metabolism UBC and SPH Division of Endocrinology Diabetes Medications in CKD Dr Adam White, MD FRCPC Endocrinology and Metabolism UBC and SPH Division of Endocrinology Objectives Broadly review the current agents used for glycemic management in Type

More information

Sheffield Kidney Institute. Planning a Clinical Trial

Sheffield Kidney Institute. Planning a Clinical Trial Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase

More information