Impacts of PIO/MET Following Short-term Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes
Status:
Unknown status
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
Summary
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.