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

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1 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 trial is to assess and compare the effect on blood sugar control of insulin detemir and insulin aspart or insulin detemir alone administered by a insulin pen PDS290 (FlexTouch ) versus a Novo Nordisk marketed insulin pen (FlexPen ) in subjects with type 1 or type 2 diabetes mellitus. Furthermore, the subject's preference of the devices will be investigated by the use of questionnaires. Scientific Title A Multi-centre, Randomised, Open-label, Cross-over Study to Explore Effectiveness, Safety, and Preference of a New Disposable Pen PDS290 versus FlexPen in Subjects with Type 1 or Type 2 Diabetes Trial IDs and acronym(s) Novo Nordisk Trial ID PDS Clinical Trials.gov Registration NCT Other Identifier(s) Condition Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery systems Trial dates Start date: 29.Sep.2008 Primary completion date: 22.Jun.2009 Completion date: 22.Jun.2009 Trial phase Phase 3 Treatment FlexTouch FlexPen Arm Information with Assigned Treatment No. of arms: 2 PDS290 --> FlexPen (Experimental): Arm description: Subjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen for 12 weeks (treatment sequence 2) Device: FlexTouch Page 1

2 Device: FlexPen FlexPen --> PDS290 (Experimental): Arm description: Subjects will receive trial drug with FlexPen for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2) Device: FlexTouch Device: FlexPen Trial status Completed No. of trial participants 242 Age eligible for trial participation 18 Years and above Genders eligible for trial participation Both Inclusion criteria Informed consent obtained before any trialrelated activities Subjects diagnosed with type 1 or type 2 diabetes. If type 2 diabetics, treatment with or without oral anti diabetic medication is allowed Current users of vial/syringe (pen naïve) treated with short-acting insulin (insulin aspart, glulisine or lispro) and once daily long-acting insulin (detemir or glargine) or once daily long-acting insulin (detemir or glargine) alone Treatment with insulin (i.e. aspart, glulisine, lispro, detemir or glargine) for at least 6 months Body Mass Index (BMI) less than 45.0 kg/m^2 HbA1c less than or equal to 9.0% at Exclusion criteria Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or inadequate contraceptive techniques during the trial period (adequate contraceptive measures are considered as intrauterine device, oral contraceptives and barrier methods) Previous participation in this trial (screening visit) Systemic drugs that may influence glycaemic control (e.g., corticosteroids) Known or suspected allergy to trial product(s) or related products Known or suspected abuse of alcohol or drug abuse Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Page 2

3 screening visit based on analysis from central laboratory Able and willing to adhere to the trialspecific insulin regimen for the entire trial period Previous treatment with sitagliptin Clinically significant, active (or over the past 12 months) disease of the gastrointestinal, neurological, genitourinary, or haematological systems Cardiac disease defined as: Decompensated heart failure (New York Heart class III or IV, unstable angina pectoris within the past 6 months of study enrolment, myocardial infarction within the past 12 months and a clinically significant history of arrhythmias or conduction delays on electrocardiogram (ECG) over the past 12 months Any other severe acute or chronic illness as judged by the Investigator Recurrent major hypoglycaemia (defined as severe central nervous system dysfunction associated with hypoglycaemia, requiring the assistance of another person) or hypoglycaemia unawareness (defined as a condition in which subjects no longer experience the usual warning signs of hypoglycaemia; the symptoms of hypoglycaemia may be different, less pronounced or even absent) or hospitalisation for diabetic ketoacidosis during the previous six months Any other conditions that the Investigator judges would interfere with trial participation or evaluation of results (i.e. planned any diagnostic or therapeutic medical intervention such as surgery) Participated in another clinical trial and received an investigational drug within the last 4 weeks Trial type Interventional Trial design Purpose: Treatment Allocation: Randomized Masking: Open label Control: Active Control Assignment: Crossover Assignment Endpoint: Safety/Efficacy Study Primary outcome Secondary outcome(s) HbA1c (glycosylated haemoglobin) for Percentage of subject having preference for Page 3

4 participants treated with PDS290 and FlexPen Time frame: Week 12 of each treatment sequence PDS290 versus FlexPen in terms of convenience and ease of use Summary score for treatment satisfaction Score for treatment impact measure for diabetes Clinical technical complaints (CTC/week) Time frame: Weeks 0-24 (whole trial period) Number of hypoglycaemic episodes Time frame: Weeks 0-12 (first treatment) and (second treatment) Number of adverse device effects Time frame: From randomisation (week 0) and until 7 days after Week 24 (Visit 16) Hypoglycaemic episodes, number of events per subject day Time frame: Weeks 0-12 (first treatment) and (second treatment) Participating countries United States: Completed Health authority approval obtained from 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 Nadeau Daniel A, Campos Carlos, Niemeyer Marcus, Bailey Timothy. Healthcare professional and patient assessment of a new prefilled insulin pen versus two widely available prefilled insulin pens for ease of use, teaching and learning. Current medical research and opinion 2011; 28 (1): 3-13 Hemmingsen H, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. A Prefilled Insulin Pen with a Novel Injection Mechanism and a Lower Injection Force than Other Prefilled Insulin Pens. Diabetes technology & therapeutics 2011; 13 (12) Bailey T, Thurman J, Niemeyer M, Schmeisl G. Usability and preference evaluation of a prefilled insulin pen with a novel injection mechanism by people with diabetes and healthcare professionals. Current medical research and opinion 2011; 27 (10): Page 4

5 Oyer David, Narendran Parth, Qvist Marianne, Niemeyer Marcus, Nadeau Daniel A. Ease of use and preference of a new versus widely available prefilled insulin pen assessed by people with diabetes, physicians and nurses. Expert opinion on drug delivery 2011; 8 (10): Wielandt Jakob O, Niemeyer Marcus, Hansen Marianne R, Bucher Ditlef, Thomsen Niels B. An assessment of dose accuracy and injection force of a novel prefilled insulin pen: comparison with a widely used prefilled insulin pen. Expert opinion on drug delivery 2011; 8 (10): Garg S, Bailey T, Deluzio T, Pollom D. Preference for a new prefilled insulin pen compared with the original pen. Current medical research and opinion 2011; 27 (12): Labeling information EU: No EMA specific device labelling information available US: No US specific device labelling information available Information provided by Novo Nordisk A/S Protocol Information Published: 14.Oct.2008 Protocol Information Last Updated: 05.Jan.2016 PDF generation date: 16.Jun Page 5

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