A Postmarketing Clinical Study of Repaglinide in Combination with Insulin in Patients with Type 2 Diabetes Mellitus
Phase 4
Completed
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT1080223173
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
Repaglinide in combination with a long-acting insulin improved HbA1c levels without major safety issues.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 117
Inclusion Criteria
Patients with type 2 diabetes mellitus who meet the following requirements
-Patients who have been on a fixed regimen of diet and exercise therapies
-Patients who are on a fixed dosage regimen of long-acting insulin
-Patients whose HbA1c level is 7.0% <= HbA1c <= 10.0% and is stable over 4 weeks
-Patients aged 20 or older
-Outpatients
etc.
Exclusion Criteria
Patients with hepatic impairment
Patients with renal impairment
Patients with cardiac diseases
Patients with severe hypertension
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>HbA1c level<br>Change from baseline at Week 12
- Secondary Outcome Measures
Name Time Method safety<br>Proportion of patients who achieved a therapeutic target for diabetes mellitus etc.<br>At each evaluation time point