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 |
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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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