NCT02897219

A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

Phase III Study of ASP1941 Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks).

Detailed description

This study consists of two parts. In Part 1, ASP1941 or placebo will be administered orally in a blind manner. In Part 2, the long-term safety and efficacy of ASP1941 will be evaluated in patients who have participated in the study and completed the Part 1.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ipragliflozin	Oral administration once daily
DRUG	Placebo	Oral administration once daily
OTHER	Insulin Therapy	Continuous subcutaneous insulin infusion or multiple daily injections as standard of care

Timeline

• Start date: 2016-08-29
• Primary completion: 2017-07-22
• Completion: 2018-03-15
• First posted: 2016-09-13
• Last updated: 2024-11-12

Locations

36 sites across 1 country: Japan