Evidence map›Paper›PMID 17300595›Full record

Trial reportDiabetes, obesity & metabolism2007

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial.

M A Nauck, G Meininger, D Sheng, L Terranella, P P Stein, Sitagliptin Study 024 Group

3 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 188 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
188citing papers in PubMed, 21 pooled it
52.0field-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.

NCT05032001 naunknown statusstarted 2021, after this paper: background citation

ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.

Ran2021Enrolled30Registered outcomes2Posted comparisons0ConditionsAbdominal Obesity, Type 2 DiabetesArmsBiguanide, DPP4 inhibitors, SGLT2 inhibitors
PMID 22238392PMID 17653063PMID 30953516PMID 29225209PMID 26694460PMID 26620129PMID 26092476other papers from this trial
Open the trial in the graph
NCT00094770 phase3completednot on this map

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2004 to 2007Enrolled1,172ConditionsDiabetes Mellitus, Type 2Armssitagliptin (MK0431), Comparator: glipizide
NCT01092663 nacompletednot on this mapstarted 2010, after this paper: background citation

The Effects of Co-administration of Colesevelam and Sitagliptin on Glucose Metabolism in Patients With Type 2 Diabetes

TypeinterventionalSponsorKineMedRan2010 to 2011Enrolled61ConditionsDiabetes Mellitus, Type 2ArmsColesevelam HCl, Sitagliptin
3 · Its place in the literature

Who cites it

188 citing papers in PubMed, 21 syntheses or guidelines pooled it, 663 citations in OpenAlex.

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  17. Guideline
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  19. 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
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  20. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2008
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128 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

6 authors at 3 institutions in 3 countries.

M A NauckDiabeteszentrum Bad Lauterberg im Harz, Bad Lauterberg, Germany.
G Meininger
D Sheng
L Terranella
P P Stein
Sitagliptin Study 024 Group
Merck & Co., Inc., Rahway, NJ, USA (United States) · USDiabeteszentrum Bad Lauterberg · DETiGenix (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [haemoglobin A(1c) (HbA(1c)) > or = 6.5 and < or = 10%] on metformin monotherapy.

methodsAfter a metformin dose titration/stabilization period (> or = 1500 mg/day), 1172 patients were randomized to the addition of sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (uptitrated to a potential maximum 20 mg/day) (N = 584) for 52 weeks. The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA(1c) changes from baseline at Week 52 using a per-protocol approach.

resultsFrom a mean baseline of 7.5%, HbA(1c) changes from baseline were -0.67% at Week 52 in both groups, confirming non-inferiority. The proportions achieving an HbA(1c) < 7% were 63% (sitagliptin) and 59% (glipizide). Fasting plasma glucose changes from baseline were -0.56 mmol/l (-10.0 mg/dl) and -0.42 mmol/l (-7.5 mg/dl) for sitagliptin and glipizide, respectively. The proportion of patients experiencing hypoglycaemia episodes was significantly (p < 0.001) higher with glipizide (32%) than with sitagliptin (5%), with 657 events in glipizide-treated patients compared with 50 events in sitagliptin-treated patients. Sitagliptin led to weight loss (change from baseline =-1.5 kg) compared with weight gain (+1.1 kg) with glipizide [between-treatment difference (95% confidence interval) =-2.5 kg (-3.1, -2.0); p < 0.001].

conclusionsIn this study, the addition of sitagliptin compared with glipizide provided similar HbA(1c)-lowering efficacy over 52 weeks in patients on ongoing metformin therapy. Sitagliptin was generally well tolerated, with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide.

Indexed as

AdolescentAdultAgedBlood GlucoseDiabetes Mellitus, Type 2Dipeptidyl Peptidase 4Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodFemaleGlipizideGlycated HemoglobinHumansHypoglycemic AgentsInsulinMaleMetforminBlood GlucoseDipeptidyl Peptidase 4Dipeptidyl-Peptidase IV InhibitorsDPP4 protein, humanGlipizideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinMetforminProtease InhibitorsPyrazinesSitagliptin PhosphateTriazoles

Identifiers

PMID17300595
OpenAlexW2018192866

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.