Efficacy of Metformin in Patients with Non-Insulin-Dependent Diabetes Mellitus
Abstract
BACKGROUND: Sulfonylurea drugs have been the only oral therapy available for patients with non-insulin-dependent diabetes mellitus (NIDDM) in the United States. Recently, however, metformin has been approved for the treatment of NIDDM. METHODS: We performed two large, randomized, parallel-group, double-blind, controlled studies in which metformin or another treatment was given for 29 weeks to moderately obese patients with NIDDM whose diabetes was inadequately controlled by diet (protocol 1: metformin vs. placebo; 289 patients), or diet plus glyburide (protocol 2: metformin and glyburide vs. metformin vs. glyburide; 632 patients). To determine efficacy we measured plasma glucose (while the patients were fasting and after the oral administration of glucose), lactate, lipids, insulin, and glycosylated hemoglobin before, during, and at the end of the study. RESULTS: In protocol 1, at the end of the study the 143 patients in the metformin group, as compared with the 146 patients in the placebo group, had lower mean (+/- SE) fasting plasma glucose concentrations (189 +/- 5 vs. 244 +/- 6 mg per deciliter [10.6 +/- 0.3 vs. 13.7 +/- 0.3 mmol per liter], P < 0.001) and glycosylated hemoglobin values (7.1 +/- 0.1 percent vs. 8.6 +/- 0.2 percent, P < 0.001). In protocol 2, the 213 patients given metformin and glyburide, as compared with the 210 patients treated with glyburide alone, had lower mean fasting plasma glucose concentrations (187 +/- 4 vs. 261 +/- 4 mg per deciliter [10.5 +/- 0.2 vs. 14.6 +/- 0.2 mmol per liter], P < 0.001) and glycosylated hemoglobin values (7.1 +/- 0.1 percent vs. 8.7 +/- 0.1 percent, P < 0.001). The effect of metformin alone was similar to that of glyburide alone. Eighteen percent of the patients given metformin and glyburide had symptoms compatible with hypoglycemia, as compared with 3 percent in the glyburide group and 2 percent in the metformin group. In both protocols the patients given metformin had statistically significant decreases in plasma total and low-density lipoprotein cholesterol and triglyceride concentrations, whereas the values in the respective control groups did not change. There were no significant changes in fasting plasma lactate concentrations in any of the groups. CONCLUSIONS: Metformin monotherapy and combination therapy with metformin and sulfonylurea are well tolerated and improve glycemic control and lipid concentrations in patients with NIDDM whose diabetes is poorly controlled with diet or sulfonylurea therapy alone.
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Metformin decreases fasting plasma glucose concentration and hemoglobin A1c by conserving β-cell function or by decreasing liver glucose production (hepatic gluconeogenesis).
“A considerable number of studies have also found that metformin decreases fasting plasma glucose (PG) concentration and hemoglobin A1c by conserving the β-cell function or by decreasing liver glucose production (hepatic gluconeogenesis) (181–184).”
From Diabetes and Sarcopenic Obesity: Pathogenesis, Diagnosis, and Treatments (2020) · cites this paper as [182]
Typically, metformin monotherapy will lower A1C levels by approximately 1.5 percentage points.
“Typically, metformin monotherapy will lower A1C levels by ∼1.5 percentage points (27,49).”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [49]
Sulfonylureas appear to be similar to metformin in efficacy, lowering A1C levels by approximately 1.5 percentage points.
“In terms of efficacy, they appear to be similar to metformin, lowering A1C levels by ∼1.5 percentage points (26,49).”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [49]
In the Diabetes Prevention Program trial, mean weight loss was 0.1, 2.1, and 5.6 kg in the placebo, metformin, and lifestyle-intervention groups, respectively.
“During this time, the mean weight loss was 0.1, 2.1, and 5.6 kg in the placebo, metformin, and lifestyle-intervention groups, respectively.”
In the Diabetes Prevention Program trial, BP decreased in the lifestyle intervention group but not in the metformin group.
“BP decreased in the lifestyle intervention group but not in the metformin group.160,199,200”
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- Authors
- DeFronzo, R. A., & Goodman, A. M.
- Affiliations
- The University of Texas at San Antonio Health Science Center (US)
- ORCID
- DeFronzo, Ralph A.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1995-08-31
- Volume
- 333
- Issue
- 9
- Pages
- 541-549
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2324992560
- Cited by
- 1,368
- References
- 3
- Citations by year
- 2026: 12 · 2025: 29 · 2024: 56 · 2023: 41 · 2022: 30 · 2021: 41 · 2020: 34 · 2019: 33 · 2018: 22 · 2017: 54 · 2016: 32 · 2015: 33 · 2014: 43 · 2013: 51 · 2012: 67
- FWCI
- 25.80
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- metformin, type 2 diabetes, glibenclamide, sulfonylureas, oral antidiabetic therapy, fasting blood glucose, HbA1c, hypoglycemia, obesity, drug efficacy, lactate, lipids, insulin, diet control, glycemic control
- MeSH terms
- Blood Glucose, Body Weight, Cholesterol, Diabetes Mellitus, Diabetes Mellitus, Type 2, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Fasting, Female, Folic Acid, Glyburide, Glucose Tolerance Test, Glycated Hemoglobin, Humans, Insulin, Lactates, Male, Metformin, Middle Aged, Obesity, Vitamin B 12, Treatment Failure, Lactic Acid
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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