Diabetes mellitus (GAD Ab positive non-insulin dependent diabetes mellitus)
Conditions
Interventions
1. Intervention group Sitagliptine (start 50mg, maximum 100mg) with the previous dibetes treatments. Addition of metformin or alpha-glucosidase inhibitor is possible after increasing the dose of sita
if HbA1c is 9.4%(NGSP) or over, the trial terminates in the patient. In principle, 5 years follow-up with annual evaluation by an independent monitoring committee.
2. Control group Pioglitazone (sta
if HbA1c is 9.4%(NGSP) or over, the trial terminates in the patient. In principle, 5 years follow-up with annual evaluation by an independent monitoring committee.
Sponsors
Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HbA1c: 6.9-8.4%(NGSP) GAD Ab positive fasting serum C-peptide: 1.0ng/ml or higher duration: 6 months-5 years age: 20 years-79 years medication for diabetes: none or biguanide only at least 2 months before registration
Exclusion criteria
Exclusion criteria: pregnant or planning to be pregnant moderate renal dysfunction: Ccr < or = 50 mL/min, or serum Cr > or = 1.5 mg/dL (male) or 1.3 mg/dL (female) severe complication that is inappropriate for trial physician's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c values, and fraction and period from registration of patients whose HbA1c values become 9.4 %(NGSP) or above | — |
Secondary
| Measure | Time frame |
|---|---|
| glucose and C-peptide values in annual 75 g OGTTs body weight blood pressure islet autoantibodies (GAD Ab, IA-2 Ab, IAA, ZnT8 Ab) fasting glucose values fasting C-peptide values | — |
Countries
Japan
Contacts
Public ContactTakuya Awata
Saitama Medical University Department of Endocrinology and Diabetes
Outcome results
None listed