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Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv7
  2. Primary completion date: Apr 2029 to Apr 30, 2029
    • Study completion date: Apr 2029 to Jun 30, 2029
    v6
  3. Enrollment target: 730 to 256
    • Study completion date: Jun 2029 to Apr 2029
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Nov 2024 to Nov 7, 2024
    v4
  5. Start date: Sep 2024 to Nov 2024v3
  6. Start date: Jul 2024 to Sep 2024v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.
Trial Details
NCT Number NCT06246799
Lead Sponsor The University of Texas Health Science Center at San Antonio
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Type 2 Diabetes (Adult Onset)
Related terms Diabetes Mellitus, Type 2
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov