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.
Muhammad Abdul-Ghani
(210) 557-1157
abdulghani@uthscsa.edu
Alberto Chavez-Velazquez
alberto.chavez-velazquez@uhs-sa.com
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu
Michael Hewitt
+1 (210) 567-6691
hewittm@uthscsa.edu
Monica Palomo
(210) 567-6710
palomom@uthscsa.edu
Principal Investigator
Muhammad Abdul-Ghani
Muhammad Abdul-Ghani
(210) 557-1157
abdulghani@uthscsa.edu
Alberto Chavez-Velazquez
alberto.chavez-velazquez@uhs-sa.com
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu
Monica Palomo
(210) 567-6710
palomom@uthscsa.edu
Arm | Description | Intervention |
---|---|---|
Intervention | pioglitazone treatment | patients will be started on 15 mg and the dose escalated to the maximal tolerated dose |
control | subjects will receive placebo | PATIENTS WILL RECEIVE PLACEBO |