Type 2 Diabetes Mellitus Clinical Trial
Official title:
Impacts of Sequential Treatment Using Fixed Dose Pioglitazone/Metformin Combination Following Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and β-Cell Function in Patients With Newly Diagnosed Type 2 Diabetes
Short-term intensive insulin therapy (SIIT) induces glycemic remission in patients with
newly diagnosed type 2 diabetes. But remission rate reduces over time. This study aims to
investigate whether sequential treatments using fixed dose combination of
pioglitazone/metformin (15mg/500mg) after SIIT can improve clinical outcomes inpatients with
newly diagnosed type 2 diabetes.
We plan to include 50 patients with newly diagnosed type 2 diabetes who are drug naïve and
meet the inclusive criteria will be enrolled. After baseline assessments, SIIT will be
applied to all patients using insulin pump to achieve and maintain euglycemia for 2 weeks.
After completion of intensive treatment, insulin pump will be stopped. Patients were
randomly assigned into either of the following two groups: PIO/MET group:
pioglitazone/metformin (15mg/500mg) will be orally administrated twice daily to the subjects
for 12 weeks; placebo group: placebo is given twice daily to all subjects for 12 weeks.
Afterwards, patients will be followed up for 48 weeks. Primary endpoint is difference in
remission rate at the end of study. Secondary endpoints include proportion of patients who
achieve glycosylated hemoglobin A1C <7% at the end of study; differences in β-cell function
, insulin sensitivity and incidence of adverse events among treatment groups.
n/a
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