Can Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?

NCT03878459 Phase 4 RECRUITING

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.

Details

Lead sponsor	The University of Texas Health Science Center at San Antonio
Phase	Phase 4
Status	RECRUITING
Enrolment	120
Start date	2019-08-08
Completion	2027-12

Conditions

• Type 1 Diabetes Mellitus

Interventions

• Pioglitazone 45 mg
• Placebo

Primary outcomes

• Decrease in HbA1c — 28 weeks

Countries

United States, Israel, Kuwait