NCT06246799 · The University of Texas Health Science Center at San Antonio
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
What this study is about
The primary purpose of this study is to evaluate the effectiveness, 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.
View original scientific description
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.
Interventions
DRUG
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.
DRUG
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.
DRUG
Sitagliptin
Sitagliptin: will be administered as a 100mg dose once daily.
DRUG
Metformin HCI XR
Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.
Primary outcome measures
number of subjects achieving HbA1c <6.5% at 6 months (Efficacy)
Time frame: 6 months
Therapy failure will be determined as HbA1c \>6.5% in two consecutive HbA1c measurements 3 months apart. Time to cumulative incidence of therapy failure curves will be created in subjects receiving pioglitazone/tirzepatide versus subjects receiving metformin/sitagliptin
Number of subjects failing to achieving HbA1c <6.5% Long-term
Time frame: month 60
The failure to achieving HbA1c \<6.5% (Durability) at the end of study in subjects receiving pioglitazone/tirzepatide (Group I) versus metformin/sitagliptin (Group II) in two consecutive HbA1c measurements 3 months apart.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- San Antonio, Texas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 10, 2026 · Source of record for eligibility and locations