Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM)
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000019033
- Lead Sponsor
- Jikei University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
1)Patients with type 1 diabetes 2)Patients with insulin therapy 3)Patients who take oral hypoglycemic agent other than metformin 4)Patients with severe acidosis or diabetic coma 5)Patients with infections, before and after surgery,and severe trauma 6)Patiens with severe liver disease 7)Patients with severe renal disease with a serum creatinine (Cr) level (mg/dL) >1.5 8)Patients with shock, heart disease (heart failure, myocardial infarction, pulmonary embolism), severe lung failure 9)Patients with malnutrition, starvation, debilitating condition, pituitary dysfunction, adrenal insufficiency 10)Patients have history of lactic acidosis 11)Heavy drinkers 12)Patients with dehydration, gastrointestinal disorders (diarrhea, vomiting,etc) 13)Cancer patients 14)Patients for the biguanide drug with a history of allergy, or with a history of other drug allergy 15)Potential pregnant patients or patient with who are breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glucose variability in CGM 1)Mean glucose levels 2)Standard deviations of glucose (SD) 3)MAGE 4)Time in hypoglycemia 5)Time in hyperglycemia 6)Area under the curve(AUC) 7)Magnitude of increase in glucose levels 8)The time to peak glucose levels from baseline after each meal
- Secondary Outcome Measures
Name Time Method Pre-meal plasma glucose, 1 hour post prandial glucose, 2 hour post prandial glucose