Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program
Open accessAbstract
OBJECTIVE: This analysis of 3,375 adults with overweight/obesity across the Semaglutide Treatment Effect in People with obesity (STEP) 1, 3, and 4 trials evaluated whether more participants with prediabetes had normoglycemia after 68 weeks’ treatment with once-weekly semaglutide 2.4 mg plus lifestyle intervention versus placebo and assessed changes in glucose metabolism in participants with prediabetes. RESEARCH DESIGN AND METHODS: STEP 1, 3, and 4 were phase 3, 68-week, randomized, placebo-controlled, multinational trials; STEP 4 had a 20-week semaglutide run-in and 48-week randomized period. Analyses included changes (week 0–68; before the washout period) in glycemic status (prespecified: STEP 1 and 3; post hoc: STEP 4), and in HbA1c, fasting plasma glucose (FPG), and HOMA insulin resistance (HOMA-IR) among participants with prediabetes (post hoc). RESULTS: Significantly more participants with baseline (week 0) prediabetes (n = 1,536) had normoglycemia at week 68 with semaglutide versus placebo (STEP 1, 84.1% vs. 47.8%; STEP 3, 89.5% vs. 55.0%; STEP 4, 89.8% vs. 70.4%; all P < 0.0001). Fewer participants with baseline normoglycemia had prediabetes at week 68 with semaglutide versus placebo (STEP 1, 2.9% vs. 10.9%; STEP 3, 3.2% vs. 5.8%; STEP 4, 1.1% vs. 5.0%). Semaglutide resulted in greater improvements in HbA1c, FPG, and HOMA-IR than placebo among participants with baseline prediabetes (all P < 0.01). CONCLUSIONS: STEP 1, 3, and 4 collectively provide a robust assessment of the effects of semaglutide on glucose metabolism and prediabetes in a large cohort of adults with overweight/obesity while on treatment. Among participants with baseline prediabetes, 68 weeks’ treatment with semaglutide versus placebo led to significant improvements in glucose metabolism and a higher likelihood of normoglycemia.
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The proportion of patients developing prediabetes among patients with baseline normoglycemia was 1.1-3.2% with semaglutide and 5.0-10.9% with placebo.
“The proportion of patients developing prediabetes among patients with baseline normoglycemia was 1.1–3.2% and 5.0–10.9% with semaglutide and placebo, respectively73”
From Incretin-based therapies for the treatment of obesity-related diseases (2024) · cites this paper as [73]
Semaglutide 2.4 mg appeared as even more beneficial on glucose metabolism than liraglutide.
“As for BW reduction, semaglutide 2.4 mg appeared as even more beneficial on glucose metabolism73”
From Incretin-based therapies for the treatment of obesity-related diseases (2024) · cites this paper as [73]
Across STEP 1, STEP 3 and STEP 4, treatment with semaglutide 2.4 mg was associated with a significant ∼30% HOMA-IR reduction.
“Across STEP 1, STEP 3 and STEP 4, treatment with semaglutide 2.4 mg was associated with a significant ∼30% HOMA-IR reduction73”
From Incretin-based therapies for the treatment of obesity-related diseases (2024) · cites this paper as [73]
A significantly greater proportion of patients with baseline prediabetes reverted to normoglycemia in the semaglutide vs. placebo group (84.1-89.8% vs. 47.8-70.4%).
“a significantly greater proportion of patients with baseline prediabetes reverted to normoglycemia in the semaglutide vs. placebo group (84.1–89.8% vs. 47.8–70.4%)73”
From Incretin-based therapies for the treatment of obesity-related diseases (2024) · cites this paper as [73]
T2D was reported in up to 1% patients on semaglutide vs. 0.9-3% in those on placebo at 68 weeks.
“T2D was reported in up to 1% patients on semaglutide vs. 0.9–3% in those on placebo at 68 weeks73”
From Incretin-based therapies for the treatment of obesity-related diseases (2024) · cites this paper as [73]
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References 35 · Cited by 87
- Authors
- Perreault, L., Davies, M., Frias, J. P., Laursen, P. N., Lingvay, I., Machineni, S., Varbo, A., Wilding, J. P. H., Wallenstein, S. O. R., & le Roux, C. W.
- Affiliations
- University of Colorado Anschutz (US)
- University of Leicester (GB)
- 3National Research Institute, Los Angeles, CA
- 4Novo Nordisk A/S, Søborg, Denmark
- The University of Texas Southwestern Medical Center (US)
- University of North Carolina at Chapel Hill (US)
- Novo Nordisk (Denmark) (DK)
- University of Liverpool (GB)
- 8Diabetes Complications Research Centre, Conway Institute, University College, Dublin, Ireland
- Corresponding author
- Perreault, Leigh
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2022-06-20
- Volume
- 45
- Issue
- 10
- Pages
- 2396-2405
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC9862484
- OpenAlex
- W4283161220
- Cited by
- 87
- References
- 35
- Citations by year
- 2026: 24 · 2025: 20 · 2024: 25 · 2023: 11 · 2022: 7
- FWCI
- 11.68
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Figshare (submittedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- semaglutide, prediabetes, glucose metabolism, glycemic status, insulin resistance, HbA1c, fasting blood glucose, obesity, overweight, lifestyle intervention, GLP-1 receptor agonists, STEP trial, normoglycemia, weight loss, type 2 diabetes prevention, GIP/GLP-1 dual agonist, SGLT2 inhibitors
- MeSH terms
- Semaglutide, Adult, Blood Glucose, Diabetes Mellitus, Type 2, Double-Blind Method, Glucagon-Like Peptides, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin Resistance, Obesity, Prediabetic State, Overweight
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