A study on efficacy and safety of a DPP-IV inhibitor in type 2 diabetes patients
Phase 4
- Conditions
- Diabetes
- Registration Number
- JPRN-UMIN000003057
- Lead Sponsor
- Saga lifestyle related disease treatment study group secretariat
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient with a history of severe ketosis, diabetic coma or pre-coma within the past 6 months 2) Patient with severe infection, a recent history of surgery, and those who are scheduled to undergo surgery soon, or serious external wound 3) Pregnant patients, including one trying to conceive pregnancy during the planned study period, and breast-feeding patients 4) Patients with modest to severe renal impairment (creatinine clearance >=30 mL/min; serum creatinine >=1.5mg/dL in men and >=1.3mg/dL in women) 5) Patients with a history of hypersensitivity to the study agent 6) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change and % change in HbA1c at 3 months after study initiation.
- Secondary Outcome Measures
Name Time Method - Change and % change in HbA1c (excluding values at 3 months), HOMA-beta, TC, HDL-C, TG and body weight at 3, 6, 9 and 12 months after study initiation - Change and % change in EQ5D and PSQI scores at 3 and 12 months after study initiation