Evidence map›Paper›PMID 19478198›Full record

Trial reportDiabetes care2009

The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone.

Ralph A DeFronzo, Miguel N Hissa, Alan J Garber, Jorge Luiz Gross, Raina Yuyan Duan, Shoba Ravichandran, Roland S Chen, Saxagliptin 014 Study Group

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

Trial report in Diabetes care, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00121667. Cited by 131 papers, 24 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
131citing papers in PubMed, 24 pooled it
37.3field-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.

NCT00121667 phase3completed

"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"

Ran2005Enrolled1,462Registered outcomes22Posted comparisons12ConditionsDiabetes Mellitus, Type 2ArmsPioglitazone, Placebo + Metformin, Saxagliptin + Metformin
Open the trial in the graph
3 · Its place in the literature

Who cites it

131 citing papers in PubMed, 24 syntheses or guidelines pooled it, 415 citations in OpenAlex.

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

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 5 institutions in 3 countries.

Ralph A DeFronzoUniversity of Texas Health Science Center at San Antonio, San Antonio, Texas, USA. albarado@uthscsa.edu
Miguel N Hissa
Alan J Garber
Jorge Luiz Gross
Raina Yuyan Duan
Shoba Ravichandran
Roland S Chen
Saxagliptin 014 Study Group
Bristol-Myers Squibb (Germany) · DEBaylor College of Medicine · USBristol-Myers Squibb (United States) · USHospital Universitário Walter Cantídio · BRThe University of Texas Health Science Center at San Antonio · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis 24-week trial assessed the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes with inadequate glycemic control with metformin alone. RESEARCH DESIGN AND

methodsThis was a randomized, double-blind, placebo-controlled study of saxagliptin (2.5, 5, or 10 mg once daily) or placebo plus a stable dose of metformin (1,500-2,500 mg) in 743 patients (A1C > or =7.0 and < or =10.0%). Efficacy analyses were performed using an ANCOVA model using last observation carried forward methodology on primary (A1C) and secondary (fasting plasma glucose [FPG] and postprandial glucose [PPG] area under the curve [AUC]) end points.

resultsSaxagliptin (2.5, 5, and 10 mg) plus metformin demonstrated statistically significant adjusted mean decreases from baseline to week 24 versus placebo in A1C (-0.59, -0.69, and -0.58 vs. +0.13%; all P < 0.0001), FPG (-14.31, -22.03, and -20.50 vs. +1.24 mg/dl; all P < 0.0001), and PPG AUC (-8,891, -9,586, and -8,137 vs. -3,291 mg . min/dl; all P < 0.0001). More than twice as many patients achieved A1C <7.0% with 2.5, 5, and 10 mg saxagliptin versus placebo (37, 44, and 44 vs. 17%; all P < 0.0001). beta-Cell function and postprandial C-peptide, insulin, and glucagon AUCs improved in all saxagliptin treatment groups at week 24. Incidence of hypoglycemic adverse events and weight reductions were similar to those with placebo.

conclusionsSaxagliptin once daily added to metformin therapy was generally well tolerated and led to statistically significant improvements in glycemic indexes versus placebo added to metformin in patients with type 2 diabetes inadequately controlled with metformin alone.

Indexed as

AdamantaneAdolescentAdultAgedBlood GlucoseDiabetes Mellitus, Type 2DipeptidesDouble-Blind MethodFemaleHumansHypoglycemic AgentsMaleMetforminMiddle AgedPlacebosTreatment OutcomeAdamantaneBlood GlucoseDipeptidesHypoglycemic AgentsMetforminPlacebossaxagliptin

Identifiers

PMID19478198
PMCPMC2732156
OpenAlexW2103058881

What Socratic 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 Socratic graph.