Comparing two treatments for recently diagnosed type 2 diabetes
Official title: Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
Run by The University of Texas Health Science Center at San Antonio · NCT06246799 · Data updated 2026-11-12
This study is testing two different treatment combinations for people who have just been diagnosed with type 2 diabetes to see which one helps lower blood sugar levels better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 256 (estimated) |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Status | Recruiting |
| Started | November 7, 2024 |
| Main results expected | April 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT06246799 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 who have been diagnosed with type 2 diabetes within the last 5 years and are either drug naïve or on metformin monotherapy.
✕Probably not a fit
Patients with certain conditions such as positive anti-GAD antibodies, pregnancy, or a history of specific cancers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness and long-term impact of two combination therapies for patients with recently diagnosed type 2 diabetes mellitus. Participants will be randomly assigned to receive either pioglitazone plus tirzepatide or metformin plus sitagliptin. The study aims to measure the reduction in HbA1c levels and explore the metabolic mechanisms behind the results. A subgroup will participate in a 6-month sub-study to further investigate these mechanisms before continuing with the main study.
Why it matters
Potential benefit: If successful, this study could provide more effective treatment options for patients with recently diagnosed type 2 diabetes.
How similar studies have gone: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Males and females; Age 18-75 years 3. Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients 4. Drug naïve or receiving metformin monotherapy 5. HbA1c \>6.5% (no limit on upper HbA1c value); 6. Willingness to adhere to the investigational product regimen 7. Good general health 8. Stable body weight over the preceding 3 months 9. Agreement to adhere to Lifestyle Considerations throughout study duration. Exclusion Criteria: 1. positive anti-GAD (antibodies to glutamic acid decarboxylase) 2. pregnancy or plan of becoming pregnant 3. evidence of proliferative diabetic retinopathy, 4. plasma creatinine \>1.4 females or \>1.5 males; 5. presence of congestive heart failure (CHF); 6. history of cancer (\<5 years); 7. prior history of pancreatitis, 8. bladder cancer or family history of thyroid tumors; 9. presence of hematuria in the urine analysis.
Where it's running
-
University Health System Texas Diabetic Institute
San Antonio, Texas, United States Recruiting -
UT Health Science Center
San Antonio, Texas, United States Recruiting
Study contacts
- Principal investigator: Muhammad Abdul-Ghani, MD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Muhammad Abdul-Ghani, MD
- Email: abdulghani@uthscsa.edu
- Phone: 210-567-6691
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.