Comparing two treatments for recently diagnosed type 2 diabetes
Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
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 |
| Enrollment | 256 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Trial ID | NCT06246799 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
San Antonio, Texas and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.