Trials / Completed
CompletedNCT02847091
Study of Ipragliflozin in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy
Post-marketing Clinical Study of Ipragliflozin; Multicenter, Open-label Study to Assess the Efficacy of Ipragliflozin Add-on in Reducing Insulin Dose in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 20 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the reduction in insulin dose from baseline at Week 24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes mellitus receiving insulin therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ipragliflozin | Oral administration, 50mg once daily |
| DRUG | Insulin | Patients are receiving insulin therapy from at least 12 weeks before Visit 1 (is allowed ±10% dose modification if clinically needed, and is reduced within a 20% to 40% range at Visit 1 and then is controlled up to Visit 8 based on criteria of this study). |
Timeline
- Start date
- 2016-07-29
- Primary completion
- 2017-11-09
- Completion
- 2017-11-09
- First posted
- 2016-07-28
- Last updated
- 2024-11-12
Locations
15 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02847091. Inclusion in this directory is not an endorsement.