Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials

J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.

Abstract

Context: Variations in the prevalence and etiology of type 2 diabetes (T2D) across race and ethnicity may affect treatment responses. Semaglutide is a glucagon-like peptide-1 analog approved for once-weekly, subcutaneous treatment of T2D.

Objective: To compare semaglutide efficacy and safety in race and ethnicity subgroups across the SUSTAIN trials.

Design: Post hoc analysis of data from phase 3 randomized SUSTAIN 1-5 and 7 (pooled), and SUSTAIN 6 trials.

Participants: 3074 subjects (SUSTAIN 1-5 and 7) and 1648 subjects (SUSTAIN 6).

Interventions: Semaglutide 0.5 or 1.0 mg, placebo, or active comparator (sitagliptin 100 mg, exenatide extended release 2.0 mg, insulin glargine 100IU/ml and dulaglutide 0.75 or 1.5 mg).

Main outcome measures: Change in hemoglobin A1C (HbA1c) and body weight from baseline to weeks 30, 40 and 104, and other efficacy and safety endpoints.

Results: HbA1c was reduced from baseline by 1.0 to 1.5 percentage points and 1.3 to 2.0 percentage points, and body weight was reduced by 2.3 to 4.7 kg and 3.6 to 6.1 kg with semaglutide 0.5 and 1.0 mg, respectively, across race and ethnicity subgroups. Minor changes in blood pressure and lipid profiles were observed. Adverse events (AEs) were reported in similar proportions of subjects across trials. More Asian versus other race subgroups discontinued treatment prematurely due to AEs. The most commonly reported AEs were gastrointestinal disorders.

Conclusions: In this SUSTAIN trials post hoc analysis, semaglutide was associated with consistent and clinically relevant reductions in HbA1c and body weight in subjects with T2D, with minor variations in efficacy and safety outcomes associated with race or ethnicity.

Trial registration: ClinicalTrials.gov NCT02054897 NCT01930188 NCT01885208 NCT02128932 NCT02305381 NCT01720446 NCT02648204.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Blood Glucose / drug effects
  • Body Weight / drug effects
  • Body Weight / ethnology
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / ethnology
  • Ethnicity / statistics & numerical data*
  • Female
  • Glucagon-Like Peptides / administration & dosage*
  • Glucagon-Like Peptides / analogs & derivatives
  • Glycated Hemoglobin A / drug effects
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Immunoglobulin Fc Fragments / administration & dosage
  • Insulin Glargine / administration & dosage
  • Male
  • Middle Aged
  • Racial Groups / statistics & numerical data*
  • Recombinant Fusion Proteins / administration & dosage
  • Treatment Outcome

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Immunoglobulin Fc Fragments
  • Recombinant Fusion Proteins
  • hemoglobin A1c protein, human
  • Insulin Glargine
  • semaglutide
  • Glucagon-Like Peptides
  • dulaglutide

Associated data

  • ClinicalTrials.gov/NCT02054897
  • ClinicalTrials.gov/NCT01930188
  • ClinicalTrials.gov/NCT01885208
  • ClinicalTrials.gov/NCT02128932
  • ClinicalTrials.gov/NCT02305381
  • ClinicalTrials.gov/NCT01720446
  • ClinicalTrials.gov/NCT02648204