Evidence map›Paper›PMID 19614786›Full record

Trial reportInternational journal of clinical practice2009

Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial.

A R Chacra, G H Tan, A Apanovitch, S Ravichandran, J List, R Chen, CV181-040 Investigators

Erratum issued Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical practice, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT00313313. Cited by 72 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 11 pooled it
24.9field-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.

NCT00313313 phase3completed

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone

Ran2006Enrolled768Registered outcomes4Posted comparisons0ConditionsDiabetesArmsglyburide, Metformin, Placebo, Saxagliptin
Open the trial in the graph
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 11 syntheses or guidelines pooled it, 238 citations in OpenAlex.

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  20. DPP-4 Inhibition and the Path to Clinical Proof.Frontiers in endocrinology · 2019
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12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

7 authors at 3 institutions in 3 countries.

A R ChacraDiabetes Center, Federal University of São Paulo, São Paulo, Brazil.
G H Tan
A Apanovitch
S Ravichandran
J List
R Chen
CV181-040 Investigators
Bristol-Myers Squibb (United States) · USUniversidade Federal de São Paulo · BRCebu Doctors' University · PH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsAssess the efficacy and safety of saxagliptin added to a submaximal sulphonylurea dose vs. uptitration of sulphonylurea monotherapy in patients with type 2 diabetes and inadequate glycaemic control with sulphonylurea monotherapy. METHODS AND PATIENTS: A total of 768 patients (18-77 years; HbA(1c) screening >or= 7.5 to <or= 10.0%) were randomised and treated with saxagliptin 2.5 or 5 mg in combination with glyburide 7.5 mg vs. glyburide 10 mg for 24 weeks. Blinded uptitration glyburide was allowed in the glyburide-only arm to a maximum total daily dose of 15 mg. Efficacy analyses were performed using ANCOVA and last-observation-carried-forward methodology.

resultsAt week 24, 92% of glyburide-only patients were uptitrated to a total glyburide dose of 15 mg/day. Saxagliptin 2.5 and 5 mg provided statistically significant adjusted mean decreases from baseline to week 24 vs. uptitrated glyburide, respectively, in HbA(1c) (-0.54%, -0.64% vs. +0.08%; both p < 0.0001) and fasting plasma glucose (-7, -10 vs. +1 mg/dl; p = 0.0218 and p = 0.002). The proportion of patients achieving an HbA(1c) < 7% was greater for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide (22.4% and 22.8% vs. 9.1%; both p < 0.0001). Postprandial glucose area under the curve was reduced for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide (-4296 and -5000 vs. +1196 mg.min/dl; both p < 0.0001). Adverse event occurrence was similar across all groups. Reported hypoglycaemic events were not statistically significantly different for saxagliptin 2.5 (13.3%) and 5 mg (14.6%) vs. uptitrated glyburide (10.1%).

conclusionSaxagliptin added to submaximal glyburide therapy led to statistically significant improvements vs. uptitration of glyburide alone across key glycaemic parameters and was generally well tolerated.

Indexed as

AdamantaneAdolescentAdultAgedAnalysis of VarianceBlood GlucoseDiabetes Mellitus, Type 2DipeptidesDouble-Blind MethodDrug Therapy, CombinationHumansHypoglycemic AgentsMiddle AgedSulfonylurea CompoundsTreatment OutcomeYoung AdultAdamantaneBlood GlucoseDipeptidesHypoglycemic AgentssaxagliptinSulfonylurea Compounds

Identifiers

PMID19614786
PMCPMC2779994
OpenAlexW2048728983

What Socratic holds

Textmetadata
LicenceCC BY
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.