Evidence map›Paper›PMID 28449320›Full record

Trial reportInternational journal of clinical practice2017

A randomised, double-blind, trial of the safety and efficacy of omarigliptin (a once-weekly DPP-4 inhibitor) in subjects with type 2 diabetes and renal impairment.

Antonio Chacra, Ira Gantz, Geraldine Mendizabal, Lucila Durlach, Edward A O'Neill, Zachary Zimmer, Shailaja Suryawanshi, Samuel S Engel, Eseng Lai

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical practice, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01698775 (A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control.), which is not on this map. Cited by 15 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 9 pooled it
1.1field-weighted citation impact, top 22% 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.

NCT01698775 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control.

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2012 to 2016Enrolled213ConditionsType 2 Diabetes MellitusArmsOmarigliptin, Placebo to omarigliptin, Glipizide, Placebo to glipizide, Insulin
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 9 syntheses or guidelines pooled it, 19 citations in OpenAlex.

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  14. Renoprotective Effects of DPP-4 Inhibitors.Antioxidants (Basel, Switzerland) · 2021
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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 at 2 institutions in 2 countries.

Antonio ChacraDiabetes Center, Federal University of Sao Paulo, Sao Paulo, Brazil.
Ira GantzMerck & Co., Inc., Kenilworth, NJ, USA.ORCID http://orcid.org/0000-0002-6565-7113
Geraldine MendizabalMerck & Co., Inc., Kenilworth, NJ, USA.
Lucila DurlachMerck & Co., Inc., Kenilworth, NJ, USA.
Edward A O'NeillMerck & Co., Inc., Kenilworth, NJ, USA.
Zachary ZimmerMerck & Co., Inc., Kenilworth, NJ, USA.
Shailaja SuryawanshiMerck & Co., Inc., Kenilworth, NJ, USA.
Samuel S EngelMerck & Co., Inc., Kenilworth, NJ, USA.
Eseng LaiMerck & Co., Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USUniversidade Federal de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2DM) and chronic renal impairment (RI).

methodsPatients with T2DM with moderate RI (estimated glomerular filtration rate [eGFR] ≥30 to <60 mL/min/1.73 m

resultsAfter 24 weeks, from a mean baseline HbA1c of 8.4% in the omarigliptin group and 8.3% in the placebo group, the least squares mean (95% CI) change from baseline in HbA1c in the overall population (all renal strata combined) was -0.77% (-1.00 to -0.54) in the omarigliptin group and -0.44% (-0.67 to -0.21) in the placebo group; between-group difference of -0.33% (-0.63 to -0.02); P=0.035. After 24 weeks, the incidences of subjects with symptomatic hypoglycaemia, one or more adverse event (AE), drug-related AE, serious AE and discontinuation due to an AE were similar in the omarigliptin and placebo groups.

conclusionsIn this study in subjects with T2DM and RI, relative to placebo, omarigliptin provided clinically meaningful reductions in HbA1c, had a similar incidence of symptomatic hypoglycaemia and was generally well tolerated.

Indexed as

AgedDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug Administration ScheduleFemaleGlomerular Filtration RateGlycated HemoglobinHeterocyclic Compounds, 2-RingHumansHypoglycemic AgentsKidney Failure, ChronicMaleMiddle AgedPyrans2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amineDipeptidyl-Peptidase IV InhibitorsGlycated HemoglobinHeterocyclic Compounds, 2-RingHypoglycemic AgentsPyrans

Identifiers

PMID28449320
PMCPMC6681174
OpenAlexW2609722039

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.