Actively Recruiting
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-03-10
256
Participants Needed
2
Research Sites
242 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18-75 years
- Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients
- Drug naïve or receiving metformin monotherapy
- HbA1c >6.5% (no limit on upper HbA1c value);
- Willingness to adhere to the investigational product regimen
- Good general health
- Stable body weight over the preceding 3 months
- Agreement to adhere to Lifestyle Considerations throughout study duration.
You will not qualify if you...
- positive anti-GAD (antibodies to glutamic acid decarboxylase)
- pregnancy or plan of becoming pregnant
- evidence of proliferative diabetic retinopathy,
- plasma creatinine >1.4 females or >1.5 males;
- presence of congestive heart failure (CHF);
- history of cancer (<5 years);
- prior history of pancreatitis,
- bladder cancer or family history of thyroid tumors;
- presence of hematuria in the urine analysis.
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Trial Site Locations
Total: 2 locations
1
University Health System Texas Diabetic Institute
San Antonio, Texas, United States, 78207
Actively Recruiting
2
UT Health Science Center
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
M
Muhammad Abdul-Ghani, MD
CONTACT
G
Gozde Baskoy, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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