Evidence map›Paper›PMID 28449368›Full record

Trial reportDiabetes, obesity & metabolism2017

A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes.

Ira Gantz, Taro Okamoto, Yuka Ito, Kotoba Okuyama, Edward A O'Neill, Keith D Kaufman, Samuel S Engel, Eseng Lai, the Omarigliptin Study 020 Group

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01703221 (A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy), which is not on this map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT01703221 phase3completednot on this map

A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2012 to 2014Enrolled414ConditionsType 2 Diabetes MellitusArmsOmarigliptin, Sitagliptin, Placebo to omarigliptin, Placebo to sitagliptin
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines 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

9 authors.

Ira GantzMerck & Co., Inc., Kenilworth, New Jersey.ORCID 0000-0002-6565-7113
Taro OkamotoMSD K.K., Tokyo, Japan.
Yuka ItoMSD K.K., Tokyo, Japan.
Kotoba OkuyamaMSD K.K., Tokyo, Japan.
Edward A O'NeillMerck & Co., Inc., Kenilworth, New Jersey.
Keith D KaufmanMerck & Co., Inc., Kenilworth, New Jersey.
Samuel S EngelMerck & Co., Inc., Kenilworth, New Jersey.ORCID 0000-0002-4439-6356
Eseng LaiMerck & Co., Inc., Kenilworth, New Jersey.
the Omarigliptin Study 020 Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess the safety and efficacy of omarigliptin in Japanese patients with type 2 diabetes (T2D).

methodsIn a 24-week double-blind trial, 414 patients with T2D were randomized to omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo. The double-blind period was followed by a 28-week open-label extension during which all patients received omarigliptin 25 mg once weekly. Efficacy endpoints were glycated haemoglobin (HbA1c), 2-hour postprandial glucose (PPG) and fasting plasma glucose (FPG) levels.

resultsAfter 24 weeks, the least squares (LS) mean change from baseline in HbA1c was -0.66% for omarigliptin, -0.65% for sitagliptin and 0.13% for placebo. The difference in LS mean for omarigliptin vs placebo was -0.80% ( P  < .001). The difference in LS mean for omarigliptin vs sitagliptin was -0.02% (95% confidence interval -0.15, 0.12), which met the criterion for non-inferiority to sitagliptin. Both active treatments provided significant reductions in FPG and 2-hour PPG compared with placebo (P < .001). Over the 24-week double-blind period, there were no clinically meaningful differences in the incidence rates of adverse events among the treatment groups. There was 1 episode of symptomatic hypoglycaemia in the sitagliptin group and none in the omarigliptin or placebo groups. In the 28-week open-label period, omarigliptin provided persistent improvements in glycaemic control without notable change in safety profile compared with the double-blind period. Omarigliptin had no meaningful effect on body weight.

conclusionsIn Japanese patients with T2D, omarigliptin 25 mg once weekly provided significant glucose-lowering compared with placebo and was non-inferior to sitagliptin 50 mg once daily. Omarigliptin was generally well tolerated for up to 52 weeks.

Indexed as

AgedAsian PeopleDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHeterocyclic Compounds, 2-RingHumansHypoglycemic AgentsJapanMaleMiddle AgedPlacebosPyrans2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amineDipeptidyl-Peptidase IV InhibitorsHeterocyclic Compounds, 2-RingHypoglycemic AgentsPlacebosPyransSitagliptin PhosphateincretinsMK-3102oral antihyperglycaemic agent

Identifiers

PMID28449368
PMCPMC5655696

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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 OpenQuestion graph.