A phase 3 randomized placebo-controlled trial to assess the efficacy and safety of ipragliflozin as an add-on therapy to metformin in Russian patients with inadequately controlled type 2 diabetes mellitus
| Autor: | Wim Wilpshaar, Valeria L. Orlova, Andrey F. Verbovoy, Reiner Tretter, Marina Vladimirovna Shestakova, John P.H. Wilding |
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| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty endocrine system diseases Endocrinology Diabetes and Metabolism Placebo-controlled study 030209 endocrinology & metabolism Thiophenes 030204 cardiovascular system & hematology Placebo Russia law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Endocrinology Double-Blind Method Glucosides Randomized controlled trial law Diabetes mellitus Internal medicine Internal Medicine medicine Humans Hypoglycemic Agents Sodium-Glucose Transporter 2 Inhibitors business.industry Type 2 Diabetes Mellitus General Medicine Middle Aged medicine.disease Metformin Add on therapy Treatment Outcome Ipragliflozin Diabetes Mellitus Type 2 chemistry Drug Therapy Combination Female business medicine.drug |
| Zdroj: | DIABETES RESEARCH AND CLINICAL PRACTICE |
| ISSN: | 0168-8227 |
| DOI: | 10.1016/j.diabres.2018.10.018 |
| Popis: | To assess the efficacy and safety of ipragliflozin as add-on therapy to metformin in Russian patients with type 2 diabetes mellitus.In this double-blind study conducted in 14 centers in Russia, 165 patients were randomized 2:1 to ipragliflozin (50 mg/day) or placebo for 24 weeks while continuing metformin. Patients who had HbA1c ≥ 7.0% (53 mmol/mol) at Week 12 received open-label ipragliflozin (50 mg/day) in addition to the blinded drug from Week 12-24.Significant reductions in HbA1c and body weight from baseline to Week 12 in favor of ipragliflozin were observed (adjusted mean difference to placebo: -0.3% (-3 mmol/mol), P = 0.048 and -1.34 kg, P 0.001, respectively). The incidence of AEs was similar in both groups. Uptitration to 100 mg/day ipragliflozin led to a further reduction in body weight (mean change from Week 12: -0.65 kg, P = 0.004) and an additional 13% (9/69) of patients achieving HbA1c 7.0% (53 mmol/mol) at Week 24. Incidence of AEs was similar among patients receiving ipragliflozin 50 mg/day (23.7%) and 100 mg/day (24.6%).Ipragliflozin 50 mg/day added to metformin significantly reduced HbA1c and body weight after 12 weeks and showed a safety profile comparable to placebo. Uptitration to 100 mg/day improved clinical outcomes with no additional safety concerns. |
| Databáze: | OpenAIRE |
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