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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
One tablet of fixed dose of Pioglitazone/ Metformin (15mg/30mg) will be given twice daily
One tablet of placebo will be given twice daily
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGRemission rate
Remission rate at the end of the study in each group
Time frame: 48 weeks
β-cell function
Difference in β-cell secretion capacity at the end of follow up between treatment groups
Time frame: 48 weeks
Insulin sensitivity
Difference in insulin sensitivity at the end of follow up between treatment groups
Time frame: 48 weeks
glycemic control
proportion of patients who achieve A1C\<7% at the end of follow-up
Time frame: 48 weeks
Adverse events
difference in AEs at the end of follow-up between treatment groups
Time frame: 48 weeks
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