Compares two starting drug combinations in recently diagnosed type 2 diabetes
Compares two drug combinations for lowering blood sugar in adults with new type 2 diabetes.
Key facts
- Who runs it
- The University of Texas Health Science Center at San Antonio
- Where
- San Antonio, United StatesSee the 2 sites
- Trial code
- Registry title
- Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 256 people, planned
- Started
- 7 Nov 2024
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Tirzepatide
- Pioglitazone
- Sitagliptin
- Metformin HCI XR
- Record updated
- 10 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-75 with type 2 diabetes diagnosed within the last 5 years. It compares two combination treatments.
- Age
- 18-75 years
- Sex
- Women and men can join.
- Disease stage
- Type 2 diabetes diagnosed recently (within 5 years), with HbA1c above 6.5% (48 mmol/mol).
- Earlier treatment
- People who have not taken diabetes drugs before, or who take only metformin.
- Biomarker or test result
- HbA1c above 6.5% (48 mmol/mol), with no upper limit. Anti-GAD antibodies must not be positive.
Main reasons for not taking part
- Positive anti-GAD (antibodies to glutamic acid decarboxylase)
- Pregnant or planning to become pregnant
- Congestive heart failure
- Cancer within the last 5 years, or bladder cancer
- Past pancreatitis, or family history of thyroid tumors
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- positive anti-GAD (antibodies to glutamic acid decarboxylase)
- prior history of pancreatitis,
- presence of congestive heart failure (CHF)
- bladder cancer or family history of thyroid tumors
- plasma creatinine >1.4 females or >1.5 males
- history of cancer (<5 years)
- pregnancy or plan of becoming pregnant
- evidence of proliferative diabetic retinopathy,
- presence of hematuria in the urine analysis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- University Health System Texas Diabetic InstituteSan Antonio, United StatesContact: Muhammad Abdul-Ghani, MDTaking people
- UT Health Science CenterSan Antonio, United StatesContact: Muhammad Abdul-Ghani, MDTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Group ICTreatment being tested
Tirzepatide starting at 2.5mg weekly titrated to 15mg weekly (2.5 month 1, 5mg month 2, 10mg month 3 and 15mg at month 4) with Pioglitazone beginning at 15mg daily and ending at 45mg daily (15mg month 1, 30mg month 2 and 45mg at month 3 onwards).
Treatment: Tirzepatide and Pioglitazone
- Group IIExisting treatment, for comparison
Metformin starting at 1000mg XR daily and Sitagliptin 100mg daily at week 4, Metformin will be increased to 200mg.
Treatment: Sitagliptin and Metformin HCI XR
- Group IAExisting treatment, for comparison
Tirzepatide will be started at 2.5mg and increased to 15mg by month 4. At month 6, Pioglitazone will be added to the Tirzepatide, 15 mg daily.
Treatment: Tirzepatide and Pioglitazone
- Group 1BExisting treatment, for comparison
Pioglitazone will be started at 15mg and increased to 45 mg by month 3. At month 6, tirzepatide 2.5mg will be started and increased weekly as tolerated.
Treatment: Tirzepatide and Pioglitazone
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
- Plain-language title
- Compares two starting drug combinations in recently diagnosed type 2 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06246799, who can take part
- Record updated
- 10 March 2026