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Dapagliflozin Plus Pioglitazone in T1DM
Sponsor: The University of Texas Health Science Center at San Antonio
Summary
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.
Official title: 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?
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2019-08-08
Completion Date
2027-12
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
Pioglitazone 45 mg
patients will be started on 15 mg and the dose escalated to the maximal tolerated dose
Placebo
PATIENTS WILL RECEIVE PLACEBO
Locations (3)
University Health System Texas Diabetic Institute
San Antonio, Texas, United States
Endocrinology and Diabetes Center, Rambam Medical Center
Haifa, Israel
Dasman Diabetes Institute
Kuwait City, Kuwait