NCT06246799RecruitingPhase 3
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 256 (estimated)
- First submitted
- 30 Jan 2024
- Start date
- 7 Nov 2024
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Type 2 diabetes
- NCT number
- NCT06246799
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 256
- From 7 Nov 2024 to the primary completion date, 30 Apr 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- positive anti-GAD (antibodies to glutamic acid decarboxylase)
- prior history of pancreatitis,
Other illness
- presence of congestive heart failure (CHF);
- bladder cancer or family history of thyroid tumors;
Lab values
- plasma creatinine \>1.4 females or \>1.5 males;
Age
- history of cancer (\<5 years);
Other
- pregnancy or plan of becoming pregnant
- evidence of proliferative diabetic retinopathy,
- presence of hematuria in the urine analysis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health System Texas Diabetic Institute Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| UT Health Science Center Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.