diabetes
Conditions
Interventions
None listed
Sponsors
Kansai Electric Power Medical Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those initiated and continued DPP-4 inhibitor sitagliptin monotherapy for 12 months 2) those submitted at least one 3-day food record during 18 months after sitagliptin initiation 3) those received at least four measurements of HbA1c, creatinine and bodyweight during 12 months after sitagliptin initiation
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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%] | — |
Countries
Japan
Contacts
Public ContactDaisuke Yabe
Kansai Electric Power Medical Research Institute Yutaka Seino Distinguished Center for Diabetes Center
Outcome results
None listed