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NCT03878459 · ClinicalTrials.gov registry record · Phase 4
Dapagliflozin Plus Pioglitazone in T1DM
A Phase 4 study of Type 1 Diabetes Mellitus, sponsored by The University of Texas Health Science Center at San Antonio.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT03878459 is a Phase 4 study of Type 1 Diabetes Mellitus that is actively recruiting participants, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 120 participants, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (14% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT03878459, a Phase 4 study of Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by The University of Texas Health Science Center at San Antonio.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pioglitazone 45 mg
Study Locations (3)
Other
- Endocrinology and Diabetes Center, Rambam Medical Center - Haifa
- Dasman Diabetes Institute - Kuwait City
Texas
- University Health System Texas Diabetic Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-08-08 |
| Est. Completion | 2027-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03878459
The ClinicalTrials.gov registry entry for NCT03878459 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (14% lower). The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03878459 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Other, Texas.
Frequently Asked Questions
What is clinical trial NCT03878459 about?
NCT03878459 is a clinical study titled "Dapagliflozin Plus Pioglitazone in T1DM". 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 stu...
What is the current status of trial NCT03878459?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2019-08-08. Estimated completion is 2027-12.
What conditions does trial NCT03878459 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03878459?
The interventions under investigation include: Placebo (DRUG), Pioglitazone 45 mg (DRUG).
Who is sponsoring clinical trial NCT03878459?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03878459 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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