Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Recruiting · San Antonio, Texas
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Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical 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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults age 18 to 75 who can understand the study and sign written consent
- •Males and females
- •Type 2 diabetes diagnosed within the last 5 years
- •Not currently taking diabetes drugs (drug-naïve) or only on metformin by itself
- •HbA1c above 6.5%
🚫 You may not be able to join if…
- •A positive test for anti-GAD (antibodies to glutamic acid decarboxylase)
- •Pregnancy or planning to become pregnant
- •Evidence of proliferative diabetic retinopathy
- •Kidney function showing plasma creatinine above 1.4 for females or above 1.5 for males
- •Congestive heart failure (CHF)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults ages 18–75
- ✓Have recently diagnosed type 2 diabetes (within 5 years)
- ✓Not previously on other diabetes drugs (or currently only on metformin)
- ✓HbA1c above 6.5%
- ✓Can sign consent and follow study diet/medication plans
- ✓Generally in good health with stable weight
- !Some conditions may not be a fit: Heart / cardiovascular disease, Anxiety
- !Not for people who are pregnant or breastfeeding
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •There are 4 groups in this study.
What to expect, step by step
· This study lasts about 26 weeks (~6 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 26 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Drug: Tirzepatide
- Drug: Pioglitazone
- Drug: Sitagliptin
- Drug: Metformin HCI XR
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
The University of Texas Health Science Center at San Antonio
Overseen by Muhammad Abdul-Ghani, MD
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06246799 · Locations: Texas