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, Sam Dagogo-Jack

Research output: Contribution to journalArticle

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Abstract

Aims: To conduct a phase III study to evaluate the efficacy and safety of ertugliflozin monotherapy in people with type 2 diabetes. Materials and methods: This 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. Results: At 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. Conclusions: Ertugliflozin 5 and 15 mg treatment for 26 weeks provides effective glycaemic control, reduces body weight and is generally well tolerated, when used as monotherapy.

Original languageEnglish
Pages (from-to)721-728
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume19
Issue number5
DOIs
Publication statusPublished - May 1 2017

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Type 2 Diabetes Mellitus
Exercise
Diet
Safety
Placebos
Body Weight
Blood Pressure
Glucose
Hypovolemia
Glycosylated Hemoglobin A
Therapeutics
Least-Squares Analysis
Hypoglycemia
Urinary Tract Infections
5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol
Fasting
Incidence
Infection

Keywords

  • ertugliflozin
  • monotherapy
  • SGLT2
  • type 2 diabetes mellitus

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. / Terra, Steven G.; Focht, Kristen; Davies, Melanie; Frias, Juan; Derosa, Giuseppe; Darekar, Amanda; Golm, Gregory; Johnson, Jeremy; Saur, Didier; Lauring, Brett; Dagogo-Jack, Sam.

In: Diabetes, Obesity and Metabolism, Vol. 19, No. 5, 01.05.2017, p. 721-728.

Research output: Contribution to journalArticle

Terra, Steven G. ; Focht, Kristen ; Davies, Melanie ; Frias, Juan ; Derosa, Giuseppe ; Darekar, Amanda ; Golm, Gregory ; Johnson, Jeremy ; Saur, Didier ; Lauring, Brett ; Dagogo-Jack, Sam. / Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. In: Diabetes, Obesity and Metabolism. 2017 ; Vol. 19, No. 5. pp. 721-728.
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AU - Derosa, Giuseppe

AU - Darekar, Amanda

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AU - Johnson, Jeremy

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