Evidence map›Paper›PMID 19309251›Full record

Trial reportCurrent medical research and opinion2009

Efficacy and safety of therapy with metformin plus pioglitazone in the treatment of patients with type 2 diabetes: a double-blind, placebo-controlled, clinical trial.

Kohei Kaku

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Current medical research and opinion, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01589445. Cited by 12 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 4 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT01589445 phase4completed

Modulation of Insulin Secretion and Insulin Sensitivity in Bangladeshi Type 2 Diabetic Subjects by an Insulin Sensitizer Pioglitazone and T2DM Association With PPARG Gene Polymorphism.

Ran2008Enrolled77Registered outcomes6Posted comparisons11ConditionsType 2 Diabetes MellitusArmsMetformin hydrochloride, pioglitazone hydrochloride
PMID 8013758PMID 16552630PMID 15677777PMID 20520962PMID 14984448PMID 20695906PMID 15579760PMID 7623902PMID 17145742PMID 15386821PMID 11118008PMID 17443551other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 4 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  4. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2010 · on this map
    Pooled it
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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

1 author at 1 institution in 1 country.

Kohei KakuDiabetes and Endocrine Division, Department of Medicine, Kawasaki Medical School, Okayama, Japan. kka@med.kawasaki-m.ac.jp
Kawasaki Medical School · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of combination therapy with pioglitazone and metformin in Japanese patients with type 2 diabetes. RESEARCH DESIGN AND

methodsDuring a 12-week observation period 236 patients were treated with metformin 500 or 750 mg/day. 169 patients with a confirmed HbA(1c) level >or= 6.5% were randomized (stratified according to metformin dosage) to receive pioglitazone 15 mg/day for 12 weeks then increased to 30 mg/day for a further 16 weeks (n = 83), or placebo (n = 86). Outcome measures included HbA(1c), fasting blood glucose (FBG), percentage of patients achieving HbA(1c) < 6.5%, lipid profile, and other metabolic parameters.

resultsMean HbA(1c) was reduced by 0.67% in patients receiving pioglitazone plus metformin versus an increase of 0.25% in those receiving metformin alone (p < 0.0001). After 8 weeks' treatment and until the end of the study, HbA(1c) was significantly lower with pioglitazone plus metformin and more patients in this group achieved an HbA(1c) < 6.5% (38.6% vs. 8.1%; p < 0.0001). FBG was also reduced by a significantly greater amount in patients receiving pioglitazone plus metformin compared with metformin monotherapy (-20.5 vs. 1.9 mg/dl; p < 0.0001). Combination therapy was associated with significantly increased HDL-cholesterol, total cholesterol, and adiponectin, and significantly decreased levels of fasting insulin, free fatty acids, and homeostasis model assessment insulin resistance (HOMA-R) compared with metformin monotherapy. Overall, combination therapy and monotherapy were equally well tolerated and the incidence of adverse effects 'possibly' related to therapy was 15.7% and 11.6% (p = 0.505), respectively. Edema occurred slightly more often in the combination group (6.0 vs. 1.2%).

conclusionPioglitazone plus metformin significantly improved glycemic control (HbA(1c) and FBG), and markers associated with increased insulin resistance and cardiovascular risk compared with metformin monotherapy. CLINICAL TRIAL REGISTRATION NUMBER: UMIN 000001110.

Indexed as

AdultAlgorithmsBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodDrug CombinationsFemaleGlycated HemoglobinHumansHypoglycemic AgentsLipidsMaleMetforminMiddle AgedPioglitazonePlacebosBlood GlucoseDrug CombinationsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLipidsMetforminPioglitazonePlacebosThiazolidinediones

Identifiers

PMID19309251
OpenAlexW2044802452

What Socratic 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 Socratic graph.