Phase 3
Completed N=846
Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
Metabolism and Nutrition Disorder · Obesity
Source: ClinicalTrials.gov NCT01272232 ↗
Enrolled (actual)
846
Serious AEs
8.1%
Results posted
Feb 2015
Primary outcomePrimary: Change (%) From Baseline in Body Weight (Fasting) — -5.9; -4.6; -2.0 percent change — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (%) From Baseline in Body Weight (Fasting) |
-4.7; -3.6; -2.7 | 0.0002 sig |
| PRIMARY Proportion of Subjects Losing at Least 5% of Baseline Body Weight |
49.9; 35.6; 13.8; 50.1; 64.4; 86.2 | <0.0001 sig |
| PRIMARY Proportion of Subjects Losing More Than 10% of Baseline Body Weight |
23.4; 14.4; 4.3; 76.6; 85.6; 95.7 | <0.0001 sig |
| SECONDARY Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c) |
-1.3; -1.1; -0.3 | <0.0001 sig |
| SECONDARY Proportion of Subjects Reaching Target HbA1c Below 7% |
69.2; 66.7; 27.2; 30.8; 33.3; 72.8 | <0.0001 sig |
| SECONDARY Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% |
56.5; 45.6; 15.0; 43.5; 54.4; 85.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Waist Circumference |
-5.7; -4.4; -3.2 | <0.0001 sig |
| SECONDARY Change (%) From Baseline in Body Weight (Fasting) |
-4.7; -3.6; -2.7 | 0.0002 sig |
| SECONDARY Change (%) From Week 56 to 68 in Body Weight (Fasting) |
2.3; 2.0; -0.1 | — |
| SECONDARY Change From Baseline in Waist Circumference |
-5.7; -4.4; -3.2 | <0.0001 sig |
| SECONDARY Change From Week 56 to 68 in Waist Circumference |
1.21; 1.02; -0.22 | — |
| SECONDARY Incidence of Hypoglycaemic Episodes |
34; 46; 13; 1; 2; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01272232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.