Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial
Phase 4
- Conditions
- type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000015033
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
1) severe hepatic dysfunction, renal dysfunction, heart failure, 2) history of anaphylaxis of drugs we use, 3) pregnancy, 4) lower than 45ml/min of eGFR, 5)lower Body mass index than 22kg/m2 6) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Amplitude of glycemic excursions: MAGE
- Secondary Outcome Measures
Name Time Method 1) M-value 2) glucose area under the curve (over 180mg/dl and below 70mg/dl) 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure 8)multiple regression analysis 9)insulin dose