Type 2 Diabetes Mellitus
Conditions
Interventions
start with Sitagliptin 50 mg/day and up to 100 mg/day
start with Metformin 500 mg/day and up to 1500 mg/day
Sponsors
INSIGHT-KOBE Investigators
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. treated only with life style modification (or cesssation of previous treatment for more than 1 month) 2. obtained documented agreement 3. patients between 20 and 35 4. HbA1c (JDS) between 6.5% and 8.0%
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes and diabetes by other etiology 2. anti GAD antibogy positive (over1.5 U/ml) 3. allegy for sitagliptin or metformin 4. severe liver dysfunction 5. severe renal dysfunction 6. severe heart failure 7. poor prognosis condition (ex: malignancy) 8. pregnancy or breast-feeding woman 9. metabolic emergency (DKA, HHS) 10. insulin user 11.psychological disorder 12. hypoglycemia unawareness 13. steroid user 14. other improper patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in CPR index during 3years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. duration to monotherapy failure 2. HbA1c, MAGE obtained from SMBG 3. new onset or progression of micro, macrovascular complication 4. HOMA beta, HOMA-R, proinsulin/insulin ratio 5. adverse event and body weight change | — |
Countries
Japan
Contacts
Public ContactKazuhiko Sakaguchi
Kobe University Graduate School of Medicine Division of diabetes and metabolism
Outcome results
None listed