Evidence map›Paper›PMID 12502670›Full record

Trial reportDiabetes care2003

Metformin as an adjunct therapy in adolescents with type 1 diabetes and insulin resistance: a randomized controlled trial.

Jill Hamilton, Elizabeth Cummings, Vera Zdravkovic, Diane Finegood, Denis Daneman

Registry-linked trialOpen access · bronzeAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01881828 (A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents With Type 1 Diabetes), which is not on this map. Cited by 37 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 7 pooled it
11.3field-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.

NCT01881828 phase3completedstarted 2013, after this paper: background citation

A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents With Type 1 Diabetes

Ran2013Enrolled164Registered outcomes16Posted comparisons0ConditionsType 1 DiabetesArmsMetformin (glucophage), oral placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 7 syntheses or guidelines pooled it, 161 citations in OpenAlex.

  1. Pooled it
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  5. Drug interventions for the treatment of obesity in children and adolescents.The Cochrane database of systematic reviews · 2016
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  17. Management of diabetes complications in youth.Therapeutic advances in endocrinology and metabolism · 2019
    Review
  18. Prevalence and identification of type 1 diabetes in Chinese adults with newly diagnosed diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2019
    Article
  19. Article
  20. A Review of Insulin Resistance in Type 1 Diabetes: Is There a Place for Adjunctive Metformin?Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018 · on this map
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Jill HamiltonDivision of Endocrinology, Hospital for Sick Children, Toronto, Ontario, Canada. jill.hamilton@sickkids.ca
Elizabeth Cummings
Vera Zdravkovic
Diane Finegood
Denis Daneman
Hospital for Sick Children · CAIzaak Walton Killam Health Centre · CASimon Fraser University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate whether, in adolescents with type 1 diabetes, the addition of metformin to insulin and standard diabetes management results in 1) higher insulin sensitivity and 2) lower HbA1c, fasting glucose, insulin dosage (units per kilogram per day) and BMI. RESEARCH DESIGN AND

methodsThis was a randomized, placebo-controlled 3-month trial of metformin therapy in 27 adolescents with type 1 diabetes, high insulin dosage (>1 unit. kg(-1). day(-1)), and HbA1c >8%, with measurements of insulin sensitivity (by frequently sampled intravenous glucose tolerance test [FSIGT]), HbA1c, insulin dosage, and BMI at the onset and end of treatment.

resultsAt t = 0, HbA1c was 9.2 +/- 0.9%, insulin dosage was 1.2 +/- 0.2 units. kg(-1). day(-1), fasting glucose was 10.6 +/- 2.4 mmol/l, and BMI was 24.2 +/- 3.9 kg/m2 (means +/- SD), with no difference between the metformin and placebo groups. At the end of the study, HbA1c was 0.6% lower in the metformin group than in the placebo group (P < 0.05). This was achieved at lower daily insulin dosages (metformin group -0.14 +/- 0.1 vs. placebo group 0.02 +/- 0.2 units. kg(-1). day(-1); P < 0.05), with no significant change in BMI. Fasting glucose levels improved significantly in the metformin group (P < 0.05). Change in insulin sensitivity, measured by FSIGT, was not significantly different between the two groups at study end. Mild hypoglycemia occurred more frequently in the metformin-treated than in the placebo subjects (1.75 +/- 0.8 vs. 0.9 +/- 0.4 events. patient(-1). week(-1); P = 0.03). There were no differences in frequency of severe hypoglycemic episodes or gastrointestinal complaints between the two groups.

conclusionsMetformin treatment lowered HbA1c and decreased insulin dosage with no weight gain in teens with type 1 diabetes in poor metabolic control. Changes in insulin sensitivity were not documented in this study using the FSIGT. Long-term studies will determine whether these improvements are sustained and whether certain subgroups accrue greater benefit from this therapy.

Indexed as

Insulin ResistanceAdolescentDiabetes Mellitus, Type 1Drug Therapy, CombinationFemaleGlucose Tolerance TestGlycated HemoglobinHumansHypoglycemic AgentsInsulinMaleMetforminTreatment OutcomeWeight GainGlycated HemoglobinHypoglycemic AgentsInsulinMetformin

Identifiers

PMID12502670
OpenAlexW2164994583

What OpenQuestion holds

Texttitle and abstract
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.