12 Apr Novel, Once Weekly GLP-RA For Diabetes Reduced HbA1c and Weight in 30 Week Trial
MedicalResearch.com Interview with:
Dr. Christopher Sorli
Christopher Sorli, MD
SUSTAIN 1 investigator and
Chair of the Department of Diabetes, Endocrinology and Metabolism
Billings Clinic, Billings, Montana
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Sorli: GLP-1 receptor agonists (GLP-1 RAs) have been found to be useful in the treatment of Type 2 diabetes with potent effects on blood glucose lowering while minimizing the risk of hypoglycemia and weight gain often seen with other classes of hypoglycemic agents.
Semaglutide is a novel GLP-1RA that is currently in clinical development. The molecule shares 94% amino acid homology with native GLP-1 and has a half-life of approximately one week allowing for once weekly dosing.
SUSTAIN 1 was designed to demonstrate superiority of semaglutide 0.5 mg and 1.0 mg once weekly over placebo in lowering HbA1c after 30 weeks of treatment. Additional secondary endpoints included weight loss versus placebo, percent of patients achieving HbA1c goals, percent of patients achieving 5% and 10% weight loss, and safety and tolerability.
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Sorli: Both doses of semaglutide were significantly more effective at improving glycaemic control after 30 weeks of treatment compared with placebo. The HbA1c reduction was 1.5% and 1.6% for semaglutide 0.5 mg and 1.0 mg, respectively, compared with 0.02% for placebo.
The HbA1c target of < 7.0% was reached by 74% and 72% of subjects treated with semaglutide 0.5 and 1.0 mg, respectively, compared with 25% treated with placebo.
The more stringent HbA1c target of ≤6.5% was reached by 59% and 60% of subjects treated with semaglutide 0.5 mg and 1.0 mg, respectively, compared with 13% treated with placebo.
Subjects in both semaglutide treatment arms experienced significantly more weight loss compared with placebo. The weight reduction was 3.7 kg and 4.5 kg for semaglutide 0.5 mg and 1.0 mg, respectively, compared with 1.0 kg for placebo.
A weight loss greater than 5% was achieved by 37% and 45% of subjects treated with semaglutide 0.5 mg and 1.0 mg, respectively, compared with 7% for placebo.
No unexpected adverse events were reported. Rates of gastrointestinal adverse events were similar to those reported with other GLP-1RAs.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Sorli: Semaglutide is a novel, once weekly GLP-RA that showed robust reductions in HbA1c over 30 weeks as compared to placebo. HbA1c goals of 7.0% and 6.5% were met by approximately three quarters and three fifths of patients respectively with no cases of severe hypoglycemia reported and weight loss of up to 4.5 kg in the 1.0 mg treatment arm. Semaglutide was well tolerated with no unexpected adverse events reported and rates of gastroinstestinal adverse events similar to other GLP-1RAs. Rates of subjects discontinuing treatment due to gastrointestinal adverse events were low.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Sorli: The semaglutide clinical development program (SUSTAIN) is an extensive program designed to assess the efficacy and safety of semaglutide in a broad range of patients with Type 2 diabetes. Additional results from these trials will help to establish the clinical efficacy and safety of semaglutide and help to guide clinicians in appropriate patient use.
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Citation: Abstract presented at April 2016 ENDO Meeting
Sorli C, Harashima S, Tsoukas G, et al. SUSTAIN 1: efficacy and safety of once-weekly semaglutide monotherapy versus placebo in subjects with type 2 diabetes. Abstract number OR15-1. Endocrine Society’s 98th Annual Meeting (ENDO), Boston, MA, US; April 1-4, 2016
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Last Updated on April 12, 2016 by Marie Benz MD FAAD