The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-Term Pharmacokinetic and 12-Week Dose-Ranging Studies
Open accessAbstract
OBJECTIVE: Delayed-release metformin (Met DR) is formulated to deliver the drug to the lower bowel to leverage the gut-based mechanisms of metformin action with lower plasma exposure. Met DR was assessed in two studies. Study 1 compared the bioavailability of single daily doses of Met DR to currently available immediate-release metformin (Met IR) and extended-release metformin (Met XR) in otherwise healthy volunteers. Study 2 assessed glycemic control in subjects with type 2 diabetes (T2DM) over 12 weeks. RESEARCH DESIGN AND METHODS: Study 1 was a phase 1, randomized, four-period crossover study in 20 subjects. Study 2 was a 12-week, phase 2, multicenter, placebo-controlled, dose-ranging study in 240 subjects with T2DM randomized to receive Met DR 600, 800, or 1,000 mg administered once daily; blinded placebo; or unblinded Met XR 1,000 or 2,000 mg (reference). RESULTS: The bioavailability of 1,000 mg Met DR b.i.d. was ∼50% that of Met IR and Met XR (study 1). In study 2, 600, 800, and 1,000 mg Met DR q.d. produced statistically significant, clinically relevant, and sustained reductions in fasting plasma glucose (FPG) levels over 12 weeks compared with placebo, with an ∼40% increase in potency compared with Met XR. The placebo-subtracted changes from baseline in HbA1c level at 12 weeks were consistent with changes in FPG levels. All treatments were generally well tolerated, and adverse events were consistent with Glucophage/Glucophage XR prescribing information. CONCLUSIONS: Dissociation of the glycemic effect from plasma exposure with gut-restricted Met DR provides strong evidence for a predominantly lower bowel-mediated mechanism of metformin action.
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There are extra-hepatic sites of action of metformin with the gut being a major contributor to its clinical benefits as an anti-hyperglycemic drug via modulating glucagon-like peptide 1 levels by a duodenal AMPK-mediated pathway, as well as effects resulting from modulating the microbiota.
“We now know there are extra-hepatic sites of action of metformin with the gut being a major contributor to its clinical benefits as an anti-hyperglycemic drug via modulating glucagon-like peptide 1 (GLP-1) levels by a duodenal AMPK-mediated pathway, as well as effects resulting from modulating the microbiota (25–29).”
From A Critical Review of the Evidence That Metformin Is a Putative Anti-Aging Drug That Enhances Healthspan and Extends Lifespan (2021) · cites this paper as [26]
The release of GLP-1 contributes substantially to the antihyperglycemic effects of metformin.
“It is the release of GLP-1 that contributes substantially to the antihyperglycemic effects of metformin (26, 90, 91).”
From A Critical Review of the Evidence That Metformin Is a Putative Anti-Aging Drug That Enhances Healthspan and Extends Lifespan (2021) · cites this paper as [26]
Metformin enhances the release of glucagon-like peptide-1.
“In addition, and also via gut-mediated action, metformin enhances the release of glucagon-like peptide-1 (GLP-1).”
From A Critical Review of the Evidence That Metformin Is a Putative Anti-Aging Drug That Enhances Healthspan and Extends Lifespan (2021) · cites this paper as [26]
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- Authors
- Buse, J. B., DeFronzo, R. A., Rosenstock, J., Kim, T., Burns, C., Skare, S., Baron, A., & Fineman, M.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- The University of Texas at San Antonio Health Science Center (US)
- Dallas Diabetes and Endocrine Center, Dallas, TX
- Elcelyx Therapeutics, San Diego, CA
- Corresponding author
- Fineman, Mark
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2015-08-18
- Volume
- 39
- Issue
- 2
- Pages
- 198-205
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W1796267606
- Cited by
- 325
- References
- 42
- Citations by year
- 2026: 13 · 2025: 17 · 2024: 24 · 2023: 29 · 2022: 23 · 2021: 33 · 2020: 25 · 2019: 33 · 2018: 36 · 2017: 47 · 2016: 40 · 2015: 3
- FWCI
- 36.42
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- UNC Libraries
- Funders
- Elcelyx Therapeutics
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Metabolism, Diabetes, and Cancer
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- metformin, type 2 diabetes, glycemic control, bioavailability, fasting blood glucose, HbA1c, extended-release metformin, dose-ranging, pharmacokinetics
- MeSH terms
- Adolescent, Adult, Aged, Biological Availability, Blood Glucose, Delayed-Action Preparations, Diabetes Mellitus, Type 2, Female, Humans, Hyperglycemia, Hypoglycemic Agents, Male, Metformin, Middle Aged, Cross-Over Studies, Gastrointestinal Tract, Young Adult
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