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Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.

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

Author information

1
Department of Endocrinology, Academic Medical Centre, Amsterdam, The Netherlands.
2
Profil Institute for Metabolic Research, Neuss, Germany.
3
Division of Diabetes Endocrinology & Metabolism, University of Nebraska Medical Center, Omaha, Nebraska.
4
School of Life and Health Sciences, Aston University, Birmingham, UK.
5
Director, Metabolic Studies, Catalina Research Institute, Chino, California.
6
Novo Nordisk A/S, Søborg, Denmark.
7
Novo Nordisk Pharma Ltd., Tokyo, Japan.
8
Section of Endocrinology and Metabolism, Health Sciences Centre, University of Manitoba, Winnipeg, Canada.

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.

KEYWORDS:

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

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