Evidence map›Paper›PMID 28116776›Full record

Trial reportDiabetes, obesity & metabolism2017

Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone.

Steven G Terra, Kristen Focht, Melanie Davies, Juan Frias, Giuseppe Derosa, Amanda Darekar, Gregory Golm, Jeremy Johnson, Didier Saur, Brett Lauring and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed 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 reports registered trial NCT01958671. Cited by 80 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 21 pooled it
14.3field-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.

NCT01958671 phase3completed

A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

Ran2013Enrolled461Registered outcomes12Posted comparisons18ConditionsType 2 Diabetes MellitusArmsErtugliflozin 10 mg, Ertugliflozin 5 mg, Glimepiride, Metformin, Placebo to Ertugliflozin
Open the trial in the graph
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 21 syntheses or guidelines pooled it, 144 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Pooled it
  19. Pooled it
  20. Pooled it

20 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

11 authors at 8 institutions in 4 countries.

Steven G TerraPfizer, Andover, Massachusetts.ORCID 0000-0002-5815-6193
Kristen FochtPfizer, Collegeville, Pennsylvania.
Melanie DaviesDiabetes Research Centre, University of Leicester, Leicester, UK.ORCID 0000-0002-9987-9371
Juan FriasNational Research Institute, Los Angeles, California.
Giuseppe DerosaUniversity of Pavia and IRCCS Policlinico San Matteo Foundation, Pavia, Italy.ORCID 0000-0003-3573-4760
Amanda DarekarPfizer Ltd, Tadworth, UK.
Gregory GolmMerck & Co., Inc., Kenilworth, New Jersey.
Jeremy JohnsonMerck & Co., Inc., Kenilworth, New Jersey.
Didier SaurPfizer, Paris, France.
Brett LauringMerck & Co., Inc., Kenilworth, New Jersey.
Sam Dagogo-JackUniversity of Tennessee Health Sciences Center, Memphis, Tennessee.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USPfizer (United States) · USNational Research Institute · USPfizer (France) · FRPfizer (United Kingdom) · GBUniversity of Leicester · GBUniversity of Pavia · ITUniversity of Tennessee Health Science Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo conduct a phase III study to evaluate the efficacy and safety of ertugliflozin monotherapy in people with type 2 diabetes. MATERIALS AND

methodsThis was a 52-week, double-blind, multicentre, randomized, parallel-group study with a 26-week, placebo-controlled treatment period (phase A), followed by a 26-week active-controlled treatment period (phase B) in 461 men and women, aged ≥18 years with inadequate glycaemic control (glycated haemoglobin [HbA1c] concentration 7.0% to 10.5% [53-91 mmol/mol], inclusive) despite diet and exercise. Results from phase A are reported in the present paper. The primary endpoint was the change in HbA1c from baseline to week 26.

resultsAt week 26, the placebo-adjusted least squares mean HbA1c changes from baseline were -0.99% and -1.16% for the ertugliflozin 5 and 15 mg doses, respectively ( P  < .001 for both doses). The odds of having HbA1c <7.0% (53 mmol/mol) were significantly greater in the ertugliflozin 5 and 15 mg groups compared with the placebo group. Both doses of ertugliflozin significantly lowered fasting plasma glucose and 2-hour postprandial glucose levels and body weight. The placebo-adjusted differences in changes from baseline in systolic blood pressure were not statistically significant. A higher incidence of genital mycotic infections occurred in men and women treated with ertugliflozin compared with placebo. There was no significant difference between treatments in the proportion of participants with symptomatic hypoglycaemia or adverse events associated with urinary tract infection or hypovolaemia.

conclusionsErtugliflozin 5 and 15 mg treatment for 26 weeks provides effective glycaemic control, reduces body weight and is generally well tolerated, when used as monotherapy.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAnti-Obesity AgentsBridged Bicyclo Compounds, HeterocyclicCombined Modality TherapyDiabetes Mellitus, Type 2Diet, DiabeticDose-Response Relationship, DrugDouble-Blind MethodExerciseFemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsImmunity, MucosalAnti-Obesity AgentsBridged Bicyclo Compounds, HeterocyclicertugliflozinGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMembrane Transport ModulatorsSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 InhibitorsertugliflozinmonotherapySGLT2type 2 diabetes mellitus

Identifiers

PMID28116776
OpenAlexW2581807473

What OpenQuestion holds

Textmetadata
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.