Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: liraglutide
* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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 7.0-10.0% (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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lira 3.0 mg<br> | Drug: liraglutide<br>* Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.<br>|
| Experimental: Lira 1.8 mg<br> | Drug: liraglutide<br>* Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.<br>|
| Experimental: Placebo<br> | Drug: placebo<br>* Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (%) From Baseline in Body Weight (Fasting) | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. | Week 0, week 56 | 
| Proportion of Subjects Losing at Least 5% of Baseline Body Weight | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. | at 56 weeks | 
| Proportion of Subjects Losing More Than 10% of Baseline Body Weight | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. | at 56 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c) | Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56. | Week 0, week 56 | 
| Proportion of Subjects Reaching Target HbA1c Below 7% |  | at 56 weeks | 
| Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% |  | at 56 weeks | 
| Change From Baseline in Waist Circumference |  | Week 0, week 56 | 
| Change (%) From Baseline in Body Weight (Fasting) | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. | Week 0, week 68 | 
| Change (%) From Week 56 to 68 in Body Weight (Fasting) | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. | Week 56, week 68 | 
| Change From Baseline in Waist Circumference |  | Week 0, week 68 | 
| Change From Week 56 to 68 in Waist Circumference |  | Week 56, week 68 | 
| Incidence of Hypoglycaemic Episodes | Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]). | Weeks 0-56 |