Evidence map›Paper›PMID 26367281›Full record

Trial reportPloS one2015

A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Metformin Therapy in Overweight/Obese Youth with Type 1 Diabetes.

Benjamin Udoka Nwosu, Louise Maranda, Karen Cullen, Lisa Greenman, Jody Fleshman, Nancy McShea, Bruce A Barton, Mary M Lee

Registry-linked trialOpen access · goldFull text readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01334125. Cited by 31 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 8 pooled it
5.4field-weighted citation impact, top 4% 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.

NCT01334125 phase3completed

Glycemic Control in Children and Adolescents With Double Diabetes: Trial of Optimized Insulin-Metformin Regimen

Ran2011Enrolled28Registered outcomes4Posted comparisons5ConditionsDiabetes MellitusArmsMetformin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 8 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Drug interventions for the treatment of obesity in children and adolescents.The Cochrane database of systematic reviews · 2016
    Pooled it
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Mechanisms and early patterns of dyslipidemia in pediatric type 1 and type 2 diabetes.Journal of pediatric endocrinology & metabolism : JPEM · 2020
    Article
  20. 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

8 authors at 1 institution in 1 country.

Benjamin Udoka NwosuDivision of Pediatric Endocrinology, Department of Pediatrics, University of Massachusetts Medical School, 55 Lake Avenue N, Worcester, Massachusetts, 01655, United States of America.
Louise MarandaDepartment of Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Avenue N, Worcester, Massachusetts, 01655, United States of America.
Karen CullenDivision of Pediatric Endocrinology, Department of Pediatrics, University of Massachusetts Medical School, 55 Lake Avenue N, Worcester, Massachusetts, 01655, United States of America.
Lisa GreenmanDivision of Pediatric Endocrinology, Department of Pediatrics, University of Massachusetts Medical School, 55 Lake Avenue N, Worcester, Massachusetts, 01655, United States of America.
Jody FleshmanDivision of Pediatric Endocrinology, Department of Pediatrics, University of Massachusetts Medical School, 55 Lake Avenue N, Worcester, Massachusetts, 01655, United States of America.
Nancy McSheaDivision of Pediatric Endocrinology, Department of Pediatrics, University of Massachusetts Medical School, 55 Lake Avenue N, Worcester, Massachusetts, 01655, United States of America.
Bruce A BartonDepartment of Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Avenue N, Worcester, Massachusetts, 01655, United States of America.
Mary M LeeDivision of Pediatric Endocrinology, Department of Pediatrics, University of Massachusetts Medical School, 55 Lake Avenue N, Worcester, Massachusetts, 01655, United States of America.
University of Massachusetts Chan Medical School · US

Funding

PILOT AND FEASIBILITY PROGRAMP30DK032520 · UNIV OF MASSACHUSETTS MED SCH WORCESTER · 1986 to 2005
$7.6M
NCATS NIH HHS UL1 TR000161NCATS NIH HHS UL1 TR001453NIDDK NIH HHS P30 DK032520
6 · The paper itself

Abstract

contextInsulin resistance has been proposed as one of the causes of poor glycemic control in overweight/obese youth with type 1 diabetes (T1D). However, the role of adjunctive metformin, an insulin sensitizer, on glycemic control in these patients is unclear.

objectiveTo compare the effect of metformin vs. placebo on hemoglobin A1c (HbA1c), total daily dose (TDD) of insulin, and other parameters in overweight/obese youth with T1D. HYPOTHESIS: Adjunctive metformin therapy will improve glycemic control in overweight/obese youth with T1D. DESIGN, SETTING, AND

participantsA 9-mo randomized, double-blind, placebo controlled trial of metformin and placebo in 28 subjects (13m/15f) of ages 10-20years (y), with HbA1c >8% (64 mmol/mol), BMI >85%, and T1D > 12 months was conducted at a university outpatient facility. The metformin group consisted of 15 subjects (8 m/ 7f), of age 15.0 ± 2.5 y; while the control group was made up of 13 subjects (5m/ 8f), of age 14.5 ± 3.1y. All participants employed a self-directed treat-to-target insulin regimen based on a titration algorithm of (-2)-0-(+2) units to adjust their long-acting insulin dose every 3rd day from -3 mo through +9 mo to maintain fasting plasma glucose (FPG) between 90-120 mg/dL (5.0-6.7 mmol/L). Pubertal maturation was determined by Tanner stage.

resultsOver the course of the 9 months of observation, the between-treatment differences in HbA1c of 0.4% (9.85% [8.82 to 10.88] for placebo versus 9.46% [8.47 to 10.46] for metformin) was not significant (p = 0.903). There were non-significant reduction in fasting plasma glucose (189.4 mg/dL [133.2 to 245.6] for placebo versus 170.5 mg/dL [114.3 to 226.7] for metformin), (p = 0.927); total daily dose (TDD) of short-acting insulin per kg body weight/day(p = 0.936); and the TDD of long-acting insulin per kg body weight per day (1.15 units/kg/day [0.89 to 1.41] for placebo versus 0.90 units/kg/day [0.64 to 1.16] for metformin) (p = 0.221). There was no difference in the occurrence of hypoglycemia between the groups.

conclusionsThis 9-month RCT of adjunctive metformin therapy in overweight and obese youth with T1D resulted in a 0.4% lower HbA1c value in the metformin group compared to the placebo group.

trial registrationClinicalTrial.gov NCT01334125.

Indexed as

AdolescentAdultBlood GlucoseChemotherapy, AdjuvantChildDiabetes Mellitus, Type 1Double-Blind MethodFemaleGlycated HemoglobinHumansInsulinMaleMetforminObesityBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanInsulinMetformin

Identifiers

PMID26367281
PMCPMC4569440
OpenAlexW1666877893

What Socratic holds

Textfull text, public
LicenceCC BY
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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 Socratic graph.