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Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Sponsor: The University of Texas Health Science Center at San Antonio
Summary
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.
Official title: Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
256
Start Date
2024-11-07
Completion Date
2029-06-30
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Tirzepatide
Tirzepatide:Participants will be initiated on 2.5mg weekly and increase their dose to 5mg at week 4, 10mg at week 8 and 15mg at week 12 as tolerated.
Pioglitazone
Pioglitazone: Participants will begin therapy at 15mg daily for the first 4 weeks then increase dose to 30mg at week 4 and to 45 mg at week 8, as tolerated.
Sitagliptin
Sitagliptin: will be administered as a 100mg dose once daily.
Metformin HCI XR
Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.
Locations (2)
University Health System Texas Diabetic Institute
San Antonio, Texas, United States
UT Health Science Center
San Antonio, Texas, United States