Type 2 Diabetes
Conditions
Interventions
Treatment with sitagliptin (50 mg/day). At 16 weeks, if the HbA1c level was >
6.9%, the dose of sitagliptin was increased up to 100 mg/day.The maximum doses of glimepiride, glibenclamide, and gliclazide were 2 mg/day, 1.25 mg/day, and 40 mg/day, respectively. At 8, 16, and 24 w
70 mg/dL or symptomatic hypoglycemic symptoms were observed by the physicians, the dose of sulfonylurea was decreased gradually as follows: for glimepiride, 2 mg, 1 mg, 0.5 mg, and withdrawal
for glibenclamide, 1.25 mg, 0.625 mg, and withdrawal
and for gliclazide, 40 mg, 20 mg, 10 mg, and withdrawal.
Treatment with piogritazon (15 mg/day). At 16 weeks, if the HbA1c level was >
6.9%, the dose of pioglitazone was increased up to 30 mg/day. At 16 weeks, if the HbA1c level was >
6.9%, the dose of sitagliptin was increased up to 100 mg/day. The range of the metformin dose was 500-1500 mg/day, and the maximum doses of glimepiride, glibenclamide, and gliclazide were 2 mg/day, 1.
and for gliclazide, 40 mg, 20 mg, 10 mg, and withdrawal. If intolerable edema was evoked by treatment with pioglitazone, the dose of pioglitazone was decreased or withdrawn and diuretics were administ
Sponsors
Yokohama City Unuversity School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetic men and women between the ages of 20-75 years whose diabetes had been inadequately controlled (HbA1c, 6.9%-9.5%) with metformin and/or sulfonylurea.
Exclusion criteria
Exclusion criteria: 1) patients with a history of diabetic ketoacidosis or diabetic coma within 6 months prior to study entry 2) patients with a history of cardiac failure 3) patients who underwent a surgical operation during the observation period of this study 4) patients with severe infection or severe trauma 5) patients who were pregnant or lactating 6) patients with renal insufficiency (serum creatinine > 1.5 mg/dL, e-GFR < 30 mL/min) 7) patients with severe liver dysfunction 8) patients who had received insulin therapy 9) patients with a history of a hypersensitive reaction to sitagliptin or pioglitazone 10) patients who were judged as being inappropriate by the physicians in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the mean changes in the HbA1c level from baseline at 24 weeks between these two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| the levels of fasting blood glucose, fasting insulin, inflammation mediators, N-terminal pro-B-type natriuretic peptide, and markers of lipids, uric acid, liver function and renal function. | — |
Countries
Japan
Contacts
Public ContactMasahiro Takihata
Yokohama City Unuversity School of Medicine Department of Endcrinology & Metabolism
Outcome results
None listed