Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03878459
PHASE4

Dapagliflozin Plus Pioglitazone in T1DM

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

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

Interventions

DRUG

Pioglitazone 45 mg

patients will be started on 15 mg and the dose escalated to the maximal tolerated dose

DRUG

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