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

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
  Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
• liraglutide — DRUG
  Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
• placebo — DRUG
  Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

Study Details

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.

Key Dates

Start date

Jun 1, 2011

Status verified

Dec 2017

Primary completion

Jan 1, 2013

Completion

Jan 25, 2013

Study Design

Enrollment

846 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lira 3.0 mg
• Experimental: Lira 1.8 mg
• Experimental: Placebo

Primary Outcome Measure

Change (%) From Baseline in Body Weight (Fasting) [ Time Frame: Week 0, week 56 ]

Locations (67)

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