Dapagliflozin Plus Pioglitazone in T1DM
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|ClinicalTrials.gov Identifier: NCT03878459|
Recruitment Status : Suspended (Temporary suspension by PI due to Covid-19)
First Posted : March 18, 2019
Last Update Posted : April 24, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Pioglitazone 45 mg Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||placebo controlled intervention|
|Masking:||Double (Participant, Investigator)|
|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?|
|Actual Study Start Date :||August 8, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||April 30, 2021|
Drug: Pioglitazone 45 mg
patients will be started on 15 mg and the dose escalated to the maximal tolerated dose
Placebo Comparator: control
subjects will receive placebo
PATIENTS WILL RECEIVE PLACEBO
- Decrease in HbA1c [ Time Frame: 28 weeks ]
- plasma ketones [ Time Frame: 28 weeks ]increase in plasma ketone concentration
- insulin dose [ Time Frame: 28 weeks ]decrease in daily insulin dose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878459
|United States, Texas|
|University Health System Texas Diabetic Institute|
|San Antonio, Texas, United States, 78207|