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: clinicaltrials@novonordisk.com 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

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