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

Autor: Gregory T. Golm, Kristen Focht, Steven G. Terra, Brett Lauring, Didier Saur, Jeremy Johnson, Samuel Dagogo-Jack, Melanie J. Davies, Giuseppe Derosa, Juan P. Frias, Amanda Darekar
Rok vydání: 2017
Předmět:
Male
medicine.medical_specialty
Endocrinology
Diabetes and Metabolism
030209 endocrinology & metabolism
Type 2 diabetes
030204 cardiovascular system & hematology
Placebo
Reproductive Tract Infections
03 medical and health sciences
0302 clinical medicine
Endocrinology
Double-Blind Method
Sodium-Glucose Transporter 2
Membrane Transport Modulators
Internal medicine
Diet
Diabetic
Internal Medicine
medicine
Clinical endpoint
Humans
Hypoglycemic Agents
Adverse effect
Exercise
Immunity
Mucosal
Sodium-Glucose Transporter 2 Inhibitors
Glycated Hemoglobin
Dose-Response Relationship
Drug
business.industry
Incidence
Incidence (epidemiology)
Type 2 Diabetes Mellitus
Overweight
Bridged Bicyclo Compounds
Heterocyclic
medicine.disease
Combined Modality Therapy
Hypoglycemia
Surgery
Blood pressure
Postprandial
Diabetes Mellitus
Type 2
Mycoses
Hyperglycemia
Female
Anti-Obesity Agents
business
Zdroj: Diabetes, Obesity and Metabolism. 19:721-728
ISSN: 1462-8902
Popis: 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
Databáze: OpenAIRE
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