Clinical assessment of long-term glucose-lowering effects of DPP-4 inhibitor under different dietary habits in Japanese individual with type 2 diabetes
Not Applicable
- Conditions
- diabetes
- Registration Number
- JPRN-UMIN000027876
- Lead Sponsor
- Kansai Electric Power Medical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Those initiated sitagliptin monotherapy in replacement of other anti-diabetic 2) Those received other anti-diabetic drugs during 0 - +12 months after sitagliptin initiation 3) Those received medications affecting HbA1c levels during 0 - +12 months after sitagliptin initiation 4) those had moderate/severe renal insufficiency (creatinine >1.5 mg/dL) at sitagliptin initiation 5) those had moderate/severe hepatic insufficiency (Child-Pugh B or above) at sitagliptin initiation 6) Those became pregnant during 0 - +12 months after sitagliptin initiation 7) Those received anti-cancer therapies during -12 - +24 months after sitagliptin initiation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in intake of carbohydrates, proteins and fats as well as that of saturated fats, monounsaturated fats, and polyunsaturated fats between patients with HbA1c deteriorated 6 months after sitagliptin initiation [deltaHbA1c (12-6 mo) 0.4% or less] and those with HbA1c maintained [deotaHbA1c(12-6mo) above 0.4%]
- Secondary Outcome Measures
Name Time Method Differences in bodyweight cahnges between patients with HbA1c deteriorated 6 months after sitagliptin initiation [deltaHbA1c (12-6 mo) 0.4% or less] and those with HbA1c maintained [deotaHbA1c(12-6mo) above 0.4%]