Dapagliflozin Plus Pioglitazone in T1DM

Part of paid clinical trials in San Antonio, Texas.

Sponsor: The University of Texas Health Science Center at San Antonio
Study ID: NCT03878459
Phase: PHASE4
Status: Recruiting

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Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Pioglitazone 45 mg — DRUG
patients will be started on 15 mg and the dose escalated to the maximal tolerated dose
Placebo — DRUG
PATIENTS WILL RECEIVE PLACEBO

Study Details

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.