Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial
| Autor: | Maryna Vlasenko, Yury Shvarts, Renzo Cordera, Zhanna D. Kobalava, Lyudmila Suplotova, Gregory Arutyunov, Irina Gurieva, Sergey Nedogoda, Adriana Forti, Olga Reshetko, Jose Sgarbi, Andriy Bazylevych, Cecilia Jimeno, Carlos Jerjes - Sanchez, Iurii Rudyk |
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| Jazyk: | angličtina |
| Rok vydání: | 2009 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty Endocrinology Diabetes and Metabolism Urology Adamantane Type 2 diabetes Saxagliptin Placebo chemistry.chemical_compound Endocrinology Double-Blind Method Diabetes mellitus Internal Medicine Medicine Humans Hypoglycemic Agents Glycated Hemoglobin Dipeptidyl-Peptidase IV Inhibitors business.industry Area under the curve Dipeptides Fasting Middle Aged medicine.disease Postprandial Period Metformin Postprandial Treatment Outcome Tolerability chemistry Diabetes Mellitus Type 2 Drug Therapy Combination Female business medicine.drug |
| Popis: | Aim: The study aim was to evaluate the efficacy and safety of initial combination therapy with saxagliptin þ metformin vs. saxagliptin or metformin monotherapy in treatment-naive patients with type 2 diabetes (T2D) and inadequate glycaemic control. Methods: In this multicentre, randomized, double-blind, active-controlled phase 3 trial, 1306 treatment-naive patients with T2D � 18 to � 77 years, glycosylated haemoglobin (HbA1c) � 8t o� 12%, fasting C-peptide concentration � 1.0 ng/ml, body mass index � 40 kg/m 2 were randomized to receive saxagliptin 5 mg þ metformin 500 mg, saxagliptin 10 mg þ metformin 500 mg, saxagliptin 10 mg þ placebo or metformin 500 mg þ placebo for 24 weeks. From weeks 1-5, metformin was uptitrated in 500-mg/day increments to 2000 mg/day maximum in the saxagliptin 5 mg þ metformin, saxagliptin 10 mg þ metformin and metformin þ placebo treatment groups. The main outcome measure was HbA1c change from baseline to week 24. Selected secondary outcomes included change from baseline to week 24 in fasting plasma glucose (FPG), pro- portion of patients achieving HbA1c |
| Databáze: | OpenAIRE |
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