Type 2 diabetes
Conditions
Interventions
Sitagliptin 50 mg/day (to be stepped up to 100 mg/day when HbA1c increases by >
0.5% at 4 or 8 weeks), for 12 weeks
Sponsors
Hokuriku Incretin-based Therapy Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients of type 2 diabetes satisfying the following all criteria; 1) receiving sulfonylurea + metformin 500 &#8211; 1,000 mg/day or sulfonylurea + pioglitazone 15 &#8211; 45 mg/day for more than 8 weeks without any changes of doses and regimens 2) with the baseline HbA1c >= 6.5% and <= 9.0%, and <= 0.5% of the difference between -8 or -4 weeks and the baseline 3) having preproliferative or less advanced retinopathy, and early stage of overt proteinuria (< 1.0 g/day) or less advanced nephropathy 4) whose written informed consent is obtainable
Exclusion criteria
Exclusion criteria: Patients satisfying any of the following criteria; 1) receiving or having received sitagliptin 2) having neural diseases (including clinically overt cerebral infarction) but diabetic neuropathy 3) having arrhythmia or heart failure 4) having more than moderate renal dysfunction (sCr > 1.5 mg/dl in men, > 1.3 mg/dl in women) 5) having severe liver dysfunction 6) having malignancy 7) being pregnant, or breast-feeding 8) having any of contraindications for sitagliptin 9) having contraindications for both metformin and pioglitazone 10) suspected as pheochromocytoma, or having allergic history against glucagon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of HbA1c from the base-line to 12 weeks later | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from the base-line to 12 weeks later of the following items; fasting plasma glucose, body weight, fasting insulin, glucagon test CPR (0 and 6 min), fasting GLP-1, fasting GIP, urinary albumin, power spectrum obtained with Fourier analysis of RR-intervals of ECG | — |
Countries
Japan
Contacts
Public ContactAtsushi NAKAGAWA
Kanazawa Medical University Hospital Department of Endocrinology and Metabolism
Outcome results
None listed