Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy
Not Applicable
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000019833
- Lead Sponsor
- Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who are taking other antidiabetes agents than insulin 2) Patients with contraindications against the use of mitiglinide calcium hydrate tablets and mitiglinide calcium hydrate/voglibose combination tablets based on their package inserts 3) Patients who were judged to be ineligible by the investigator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Mean amplitude of glycemic excursions (MAGE) 2) Mean blood glucose level 3) Standard deviation (SD) of blood glucose level 4) Rate of glucose level AUC>=180 mg/dL, 70 mg/dL<AUC<180 mg/dL, and <70 mg/dL 5) Maximum and minimum blood glucose levels 6) Incidence of symptomatic hypoglycemia 7) Rate of glucose level <70 mg/dL 8) Blood glucose levels 1 and 2 h after every meal 9) Age, duration of diabetes, urinary CPR, 75g oral glucose tolerance test results (blood glucose, blood insulin, and blood CPR levels before the load, and 30 min, 1 hour and 2 hours after the load), glucagon stimulation test results (blood glucose, blood insulin, and blood CPR levels before and after the load), and the daily dose of additional insulin, the daily dose of basal insulin and the daily dose of total insulin at the time of informed consent
- Secondary Outcome Measures
Name Time Method