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Dapagliflozin Plus Pioglitazone in T1DM

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion moved earlier from Jun 2027 to Mar 15, 2026
    • Enrollment closed, study ongoing
    • Study completion pushed from Dec 2027 to Dec 31, 2027
    • Site details revised at 3 of 3 sites
    v17
  2. Site details revised at 2 of 3 sitesv16
  3. Primary completion date: Dec 2024 to Jun 2027
    • Study completion date: Jan 2025 to Dec 2027
    v15
  4. Study sites: 2 to 3v14
  5. Primary completion date: Dec 2023 to Dec 2024v13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Jun 2023 to Dec 2023
    • Study completion date: Dec 2024 to Jan 2025
    v12
  2. Primary completion date: Dec 2022 to Jun 2023
    • Study completion date: Dec 2023 to Dec 2024
    v11
  3. Primary completion date: Dec 2021 to Dec 2022
    • Study completion date: Dec 2022 to Dec 2023
    v10
  4. Study sites: 1 to 2v9
  5. Primary completion date: Dec 31, 2020 to Dec 2021
    • Study completion date: Apr 30, 2021 to Dec 2022
    v8
  6. Trial status: Suspended to Recruiting
    • Site details revised
    v7
  7. Trial status: Recruiting to Suspended Sponsor's reason: Temporary suspension by PI due to Covid-19
    • Site details revised
    v6
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2019 to Aug 8, 2019
    v5
  9. Start date: Jun 1, 2019 to Oct 1, 2019v4
  10. Start date: May 1, 2019 to Jun 1, 2019v3
  11. Eligibility criteria shortened, about 48 words
    • Study description expanded, about 3 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03878459
Lead Sponsor The University of Texas Health Science Center at San Antonio
Conditions
(from sponsor)		 Type 1 Diabetes Mellitus
Related terms Diabetes Mellitus, Type 1
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov