Evidence map›Paper›PMID 22442396›Full record

Trial reportDiabetes care2012

Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study.

Diabetes Prevention Program Research Group

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 229 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
229citing papers in PubMed, 11 pooled it
16.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03477162 early_phase1terminatednot on this mapstarted 2018, after this paper: background citation

Metformin Pharmacology in Human Cancers

TypeinterventionalSponsorDartmouth-Hitchcock Medical CenterRan2018 to 2021Enrolled18ConditionsThoracic NeoplasmArmsMetformin
NCT04267809 phase2completednot on this mapstarted 2021, after this paper: background citation

Modulating Endoplasmic Reticulum Stress as a Prophylactic Approach Against Symptomatic Viral Infection

TypeinterventionalSponsorSingapore General HospitalRan2021 to 2023Enrolled32ConditionsEndoplasmic Reticulum Stress, Viral Infection, Yellow FeverArmsMetformin Hydrochloride, Calcium and Vitamin D
3 · Its place in the literature

Who cites it

229 citing papers in PubMed, 11 syntheses or guidelines pooled it, 485 citations in OpenAlex.

  1. Pooled it
  2. Guideline
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  4. Metformin for preventing the progression of chronic kidney disease.The Cochrane database of systematic reviews · 2024 · on this map
    Pooled it
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  10. Atencion primaria · 2018
    Guideline
  11. Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
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  20. Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease: A Feasibility Study.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2022
    Trial

169 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

1 author at 1 institution in 2 countries.

Diabetes Prevention Program Research GroupDiabetes Prevention Program Coordinating Center. dppmail@bsc.gwu.edu
Pennington Biomedical Research Center · US

Funding

Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · PI Julie Mathieu · 1986 to 2026
$41.4M
Primary and Tertiary Prevention of type 2 diabetesZIADK075078 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI HANSON, ROBERT · 2012 to 2025
$4.6M
Intramural NIH HHSNIDDK NIH HHS P30 DK017047
6 · The paper itself

Abstract

objectiveMetformin produced weight loss and delayed or prevented diabetes in the Diabetes Prevention Program (DPP). We examined its long-term safety and tolerability along with weight loss, and change in waist circumference during the DPP and its long-term follow-up. RESEARCH DESIGN AND

methodsThe randomized double-blind clinical trial of metformin or placebo followed by a 7-8-year open-label extension and analysis of adverse events, tolerability, and the effect of adherence on change in weight and waist circumference.

resultsNo significant safety issues were identified. Gastrointestinal symptoms were more common in metformin than placebo participants and declined over time. During the DPP, average hemoglobin and hematocrit levels were slightly lower in the metformin group than in the placebo group. Decreases in hemoglobin and hematocrit in the metformin group occurred during the first year following randomization, with no further changes observed over time. During the DPP, metformin participants had reduced body weight and waist circumference compared with placebo (weight by 2.06 ± 5.65% vs. 0.02 ± 5.52%, P < 0.001, and waist circumference by 2.13 ± 7.06 cm vs. 0.79 ± 6.54 cm, P < 0.001 in metformin vs. placebo, respectively). The magnitude of weight loss during the 2-year double-blind period was directly related to adherence (P < 0.001). Throughout the unblinded follow-up, weight loss remained significantly greater in the metformin group than in the placebo group (2.0 vs. 0.2%, P < 0.001), and this was related to the degree of continuing metformin adherence (P < 0.001).

conclusionsMetformin used for diabetes prevention is safe and well tolerated. Weight loss is related to adherence to metformin and is durable for at least 10 years of treatment.

Indexed as

AdultAgedAged, 80 and overDiabetes Mellitus, Type 2Double-Blind MethodFemaleFollow-Up StudiesHumansHypoglycemic AgentsMaleMetforminMiddle AgedPlacebosPrediabetic StateTime FactorsTreatment OutcomeHypoglycemic AgentsMetforminPlacebos

Identifiers

PMID22442396
PMCPMC3308305
OpenAlexW2096559770

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.