Obesity and Prediabetes Trial - SCALE

Jun 07, 2017
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Novo Nordisk
Date Published:
04/08/2017
Original Posted Date:
06/07/2017
References

Contribution To Literature:

The SCALE trial showed that liraglutide was superior to placebo at preventing the onset of diabetes.

Description:

The goal of the trial was to evaluate the glucagon-like peptide-1 receptor antagonist liraglutide compared with placebo among patients with prediabetes.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Blinded
  • Stratification

Obese patients with prediabetes continued randomized treatment to subcutaneous liraglutide 3 mg (n = 1,505) versus placebo (n = 749) for 2 years after completion of enrollment in a 56-week related trial that examined liraglutide compared with placebo for weight loss.

  • Total number of enrollees: 2,254
  • Duration of follow-up: 3 years
  • Mean patient age: 47.5 years
  • Percentage female: 76%

Inclusion criteria:

  • Prediabetes
  • Obesity, or body mass index (BMI) ≥27 kg/m2 and hypertension or dyslipidemia

Exclusion criteria:

  • Diabetes type 1 or 2
  • Medications causing significant weight loss or gain
  • Bariatric surgery
  • History of pancreatitis
  • History of major depression or other severe psychiatric disorder
  • Family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma

Other salient features/characteristics:

  • 53% of the liraglutide group completed 160 weeks of additional treatment compared with 45% of the placebo group

Principal Findings:

The primary outcome, incidence of type 2 diabetes, occurred in 2% of the liraglutide group versus 6% of the placebo group (p < 0.0001).

Secondary outcomes:

  • Change in bodyweight: -6.1% for liraglutide vs. -1.9% for placebo (p < 0.0001)
  • Change in glycated hemoglobin: -0.35% for liraglutide vs. -0.14% for placebo (p < 0.0001)

Interpretation:

Among patients with prediabetes, liraglutide appeared to be beneficial at preventing the development of type 2 diabetes. Liraglutide compared with placebo was also associated with greater reduction in bodyweight and glycated hemoglobin. A limitation of the trial is that a large proportion of individuals in both treatment arms withdrew from follow-up.

References:

le Roux CW, Astrup A, Fujioka K, et al. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet 2017;389:1399-409.

Keywords: Body Mass Index, Body Weight, Diabetes Mellitus, Type 2, Dyslipidemias, Glycated Hemoglobin A, Hypertension, Metabolic Syndrome, Obesity, Prediabetic State, Primary Prevention, Risk Reduction Behavior, Weight Loss


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