Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone
- 24 January 2017
- journal article
- research article
- Published by Wiley in Diabetes, Obesity and Metabolism
- Vol. 19 (5), 721-728
- https://doi.org/10.1111/dom.12888
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.Funding Information
- European Association for the Study of Diabetes (52nd Annual Meeting 2016, Munich, Germany)
- Janssen Pharmaceuticals
- Eli Lilly and Company
- AstraZeneca
- Sanofi
- AbbVie
This publication has 19 references indexed in Scilit:
- Update on developments with SGLT2 inhibitors in the management of type 2 diabetesDrug Design, Development and Therapy, 2014
- Effects of sodium-glucose co-transporter 2 inhibitors on blood pressure: A systematic review and meta-analysisJournal of the American Society of Hypertension, 2014
- Renal Hemodynamic Effect of Sodium-Glucose Cotransporter 2 Inhibition in Patients With Type 1 Diabetes MellitusCirculation, 2014
- Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trialThe Lancet Diabetes & Endocrinology, 2013
- Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exerciseDiabetes, Obesity and Metabolism, 2013
- SGLT2 inhibition in diabetes mellitus: rationale and clinical prospectsNature Reviews Endocrinology, 2012
- Discovery of a Clinical Candidate from the Structurally Unique Dioxa-bicyclo[3.2.1]octane Class of Sodium-Dependent Glucose Cotransporter 2 InhibitorsJournal of Medicinal Chemistry, 2011
- Dapagliflozin Monotherapy in Type 2 Diabetic Patients With Inadequate Glycemic Control by Diet and ExerciseDiabetes Care, 2010
- Consensus statement on the definition of orthostatic hypotension, pure autonomic failure, and multiple system atrophyNeurology, 1996
- Comparative analysis of two ratesStatistics in Medicine, 1985