Purpose: To examine the effect of addition of combination therapy with dapagliflozin plus
pioglitazone to insulin on glucose control and plasma ketone concentration in patients with
type 1 diabetes (T1DM) Research Design: 120 patients with type 1 diabetes who otherwise are
healthy constitute the study population. After screening, eligible subjects will start 4 week
run in. At week 4, subjects will receive dapagliflozin for 12 weeks. At week 16, subjects
will be randomized to receive in a double blind fashion pioglitazone or placebo for 16 weeks.
Methods: the following techniques will be employed in the present study: (1) mixed meal
tolerance test; (2) indirect calorimetry; (3) continuous glucose monitoring.
Clinical Relevance: the results of the present study will demonstrate that the addition of
pioglitazone to SGLT2 inhibitor in T1DM patients produces greater reduction in the HbA1c
without increasing risk of ketoacidosis and hypoglycemia.
Phase:
Phase 4
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio