drugset / Trial / NCT01071850
A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.
Timeline
- Start
- 2010-03-03
- Primary completion
- 2011-04-11
- Completion
- 2011-04-11
Outcome
Met primary endpoint
paper Ipragliflozin showed a dose-dependent decrease in HbA1c of -0.49% to -0.81% at Week 12 compared with placebo (P<0.001); PMID 23276620 ↗
Publications
- Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
- Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complications. 2013 May-Jun;27(3):268-73. doi: 10.1016/j.jdiacomp.2012.11.005. Epub 2012 Dec 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | — | Oral |
| Subject | ipragliflozin | Small molecule | 12.5 mg | Oral |
| Subject | ipragliflozin | Small molecule | 50 mg | Oral |
| Subject | ipragliflozin | Small molecule | 150 mg | Oral |
| Subject | ipragliflozin | Small molecule | 300 mg | Oral |