| Trial ID: | L5377 |
| Source ID: | NCT03878459
|
| Associated Drug: |
Pioglitazone 45 Mg
|
| Title: |
Dapagliflozin Plus Pioglitazone in T1DM
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Pioglitazone 45 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Decrease in HbA1c, 28 weeks | Secondary: plasma ketones, increase in plasma ketone concentration, 28 weeks|insulin dose, decrease in daily insulin dose, 28 weeks
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-08-08
|
| Completion Date: |
2027-12
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-28
|
| Locations: |
University Health System Texas Diabetic Institute, San Antonio, Texas, 78207, United States|Endocrinology and Diabetes Center, Rambam Medical Center, Haifa, Israel|Dasman Diabetes Institute, Kuwait City, Kuwait
|
| URL: |
https://clinicaltrials.gov/show/NCT03878459
|
