Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus
Phase 2
Completed
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT02702011
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description empagliflozin high dose empagliflozin high dose - placebo placebo - empagliflozin low dose empagliflozin low dose - empagliflozin medium dose empagliflozin medium dose -
- Primary Outcome Measures
Name Time Method Change From Baseline in 24 Hour UGE on Day 7 Baseline and 7 days Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
SOUSEIKAI Sumida Hospital
🇯🇵Tokyo, Sumida-ku, Japan
Souseikai Hakata Clinic
🇯🇵Fukuoka, Fukuoka, Japan
Nishikumamoto Hospital
🇯🇵Kumamoto, Kumamoto, Japan
Shinjuku Research Park Clinic
🇯🇵Tokyo, Shinjyuku-ku, Japan