A 26-week, placebo- and pioglitazone-controlled monotherapy study of rivoglitazone in subjects with type 2 diabetes mellitus
| Autor: | Yeung-Chul Mun, D. Merante, A. Pfützner, Hubert S. Chou, Kenneth E. Truitt, Y. Choi, J. B. Moberly |
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| Rok vydání: | 2012 |
| Předmět: |
Blood Glucose
Male medicine.medical_specialty medicine.drug_class Endocrinology Diabetes and Metabolism India Placebo Gastroenterology Biomarkers Pharmacological law.invention South Africa Endocrinology Randomized controlled trial law Diabetes mellitus Internal medicine Internal Medicine medicine Humans Hypoglycemic Agents Single-Blind Method Thiazolidinedione Adverse effect Glycated Hemoglobin Pioglitazone business.industry Type 2 Diabetes Mellitus Middle Aged Lipid Metabolism medicine.disease United States Europe Treatment Outcome Rivoglitazone Diabetes Mellitus Type 2 Female Thiazolidinediones business Follow-Up Studies medicine.drug |
| Zdroj: | Diabetes, Obesity and Metabolism. 14:1000-1009 |
| ISSN: | 1462-8902 |
| DOI: | 10.1111/j.1463-1326.2012.01631.x |
| Popis: | Aims To evaluate the efficacy and safety of rivoglitazone, a peroxisome proliferator-activated receptor γ agonist in the thiazolidinedione class, in subjects with suboptimally controlled type 2 diabetes mellitus (T2DM). Methods Subjects aged ≥18 years with T2DM and haemoglobin A1c (HbA1c) >7.0% and ≤8.5%, who were treatment naive or receiving a non-thiazolidinedione antidiabetes monotherapy, entered a 2-week washout and single-blind placebo run-in period and were then randomized 2 : 4 : 11 : 11 to double-blind treatment with placebo, rivoglitazone 1.0 mg/day, rivoglitazone 1.5 mg/day, or pioglitazone 45 mg/day, for 26 weeks. Results A total of 1912 subjects received placebo (n = 137), rivoglitazone 1.0 mg (n = 274), rivoglitazone 1.5 mg (n = 750) or pioglitazone (n = 751). Rivoglitazone 1.5 mg was statistically superior (p = 0.0339) and rivoglitazone 1.0 mg was non-inferior (p = 0.0339) to pioglitazone in reducing HbA1c from baseline (changes of −0.7%, −0.4% and −0.6%, respectively). Rivoglitazone also significantly reduced fasting plasma glucose from baseline (p |
| Databáze: | OpenAIRE |
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