Open-label randomized non-inferiority trial of a fixed-dose combination of glimepiride and atorvastatin for the treatment of people whose Type 2 diabetes is uncontrolled on metformin
| Autor: | P. Ambery, A. Stylianou, G. Atkinson, K. LaCroix, N. Haque, L. Baylor Curtis, C. Dott, K. W. Min |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Endocrinology Diabetes and Metabolism Atorvastatin Fixed-dose combination Type 2 diabetes Equivalence Trials as Topic 030204 cardiovascular system & hematology Gastroenterology law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Endocrinology Randomized controlled trial law Diabetes mellitus Internal medicine Internal Medicine medicine Humans Hypoglycemic Agents 030212 general & internal medicine Aged Glycated Hemoglobin business.industry Cholesterol Cholesterol LDL Middle Aged medicine.disease Metformin Glimepiride Drug Combinations Sulfonylurea Compounds chemistry Diabetes Mellitus Type 2 Drug Therapy Combination Female Hydroxymethylglutaryl-CoA Reductase Inhibitors business medicine.drug |
| Zdroj: | Diabetic medicine : a journal of the British Diabetic Association. 33(8) |
| ISSN: | 1464-5491 |
| Popis: | To evaluate, in a randomized, open-label study, the non-inferiority of a bioequivalent fixed-dose combination of glimepiride and atorvastatin vs. separately co-administered tablets in people with Type 2 diabetes mellitus.Participants with HbA1c ≥ 53 to 80 mmol/mol (≥ 7.0 to 9.5%), average fasting blood glucose 7.0 mmol/l, who were on metformin for ≥ 3 months, were randomized to combination (n = 215) or co-administered glimepiride and atorvastatin (n = 212) once daily for 20 weeks. Up-titration of glimepiride (1-4 mg) and atorvastatin (10-20 mg) were based on average fasting blood glucose and LDL cholesterol, respectively. Co-primary endpoints were change from baseline to week 20 in HbA1c and LDL cholesterol.Non-inferiority was demonstrated for both co-primary endpoints: the upper limits of 95% CIs for differences (combination-reference) were less than the prespecified margins of 3.3 mmol/mol (0.3%) for change from baseline in HbA1c [difference 0.1 mmol/mol (95% CI -1.6, 1.9); 0.01% (95% CI -0.15, 0.17)] and 6% for percentage change from baseline in LDL cholesterol [difference 0.87% (95% CI -2.47, 4.21)]. Similar proportions of participants on combination and reference had treatment-emergent adverse events (64 vs. 61%). More participants on combination had hypoglycaemia (21 vs. 13%); most events were considered by the treating physician to be unrelated to study drug.The combination was non-inferior to separately co-administered tablets and the safety profile was consistent with the known profiles of glimepiride and atorvastatin. The observed increase in hypoglycaemia on the combination cannot be explained, but may be attributable to non-systematic collectiof glucose readings and may have been influenced by reporting bias in this open-label trial. |
| Databáze: | OpenAIRE |
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