Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme

J. Hans Devries, Cyrus V Desouza, Srikanth Bellary, Jeffrey Unger, Oluf K.H. Hansen, Jeppe Zacho, Vincent Woo

Research output: Contribution to journalArticle

Abstract

Aim: To evaluate the potential for semaglutide to help people with type 2 diabetes (T2D) achieve glycated haemoglobin (HbA1c) targets while avoiding unwanted outcomes, such as weight gain, hypoglycaemia and gastrointestinal (GI) side effects. Materials and methods: Data from the phase IIIa SUSTAIN 1 to 5 clinical trials were analysed. Participants had inadequately controlled T2D and were drug-naïve (SUSTAIN 1) or on a range of background treatments (SUSTAIN 2 to 5). The main protocol-specified composite endpoint was the proportion of participants achieving HbA1c <53 mmol/mol (7.0%) at end of treatment (30 or 56 weeks) without weight gain and with no severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia. A post hoc composite endpoint was the proportion of participants achieving the primary composite endpoint without moderate or severe GI adverse events (AEs). Results: Across the SUSTAIN trials 1 to 5, 3918 participants with T2D were randomized to once-weekly subcutaneous semaglutide 0.5 mg, 1.0 mg, or comparators (placebo, sitagliptin 100 mg, exenatide extended release 2.0 mg or insulin glargine). The proportion of participants achieving HbA1c <53 mmol/mol (7.0%) with no weight gain and no severe/BG-confirmed symptomatic hypoglycaemia was 47% to 66% (semaglutide 0.5 mg) and 57% to 74% (semaglutide 1.0 mg) vs 7% to 19% (placebo) and 16% to 29% (active comparators; all P <.0001). More participants achieved the primary composite endpoint with no moderate or severe GI AEs with semaglutide vs comparators (all P <.0001). Conclusion: Semaglutide helped more people with T2D achieve HbA1c targets than did comparators in the SUSTAIN 1 to 5 trials, while avoiding unwanted outcomes such as weight gain, hypoglycaemia and GI side effects.

Original languageEnglish (US)
Pages (from-to)2426-2434
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number10
DOIs
StatePublished - Oct 1 2018

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Hypoglycemia
Type 2 Diabetes Mellitus
Weight Gain
Clinical Trials
Blood Glucose
Placebos
Glycosylated Hemoglobin A
semaglutide
Therapeutics
Pharmaceutical Preparations

Keywords

  • GLP-1
  • glycaemic control
  • hypoglycaemia
  • type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. / Devries, J. Hans; Desouza, Cyrus V; Bellary, Srikanth; Unger, Jeffrey; Hansen, Oluf K.H.; Zacho, Jeppe; Woo, Vincent.

In: Diabetes, Obesity and Metabolism, Vol. 20, No. 10, 01.10.2018, p. 2426-2434.

Research output: Contribution to journalArticle

Devries, J. Hans ; Desouza, Cyrus V ; Bellary, Srikanth ; Unger, Jeffrey ; Hansen, Oluf K.H. ; Zacho, Jeppe ; Woo, Vincent. / Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. In: Diabetes, Obesity and Metabolism. 2018 ; Vol. 20, No. 10. pp. 2426-2434.
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