A study to test how well empagliflozin works in Japanese people with type 2 diabetes who are older than 65 years
- Conditions
- type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT1080225321
- Lead Sponsor
- ippon Boehringer Ingelheim Co., Ltd.
- Brief Summary
In elderly Japanese patients with T2DM and insufficient glycaemic control, treatment with empagliflozin (10 mg) as an add-on therapy to OADs and in treatment naive patients demonstrated a statistically significant and clinically meaningful improvement in the change from baseline in HbA1c after 52 weeks of treatment compared with placebo. Empagliflozin as an add-on therapy to OADs and in treatment naive patients was well tolerated and no new safety findings were observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 129
1.Japanese patients with diagnosis of type 2 diabetes mellitus prior to informed consent
2. Age over 65 years at informed consent
3. B+G20MI over 22 kg/m2
etc.
1. Treatment with insulin within 12 weeks prior to informed consent
2. Uncontrolled hyperglycaemia with a fasting glucose level >200 mg/dL (>11.1 mmol/L) during run-in period
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Change from baseline in glycosylated haemoglobin A1c (HbA1c) after 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method safety<br>Change of body composition from baseline to Week 52<br>Change of grip strength from baseline to Week 52<br>Change of time in the 5-time chair stand test from baseline to Week 52