What this study is
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.
What's being tested
- Tirzepatide
Intervention · DRUG
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.
- Pioglitazone
Intervention · DRUG
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.
- Sitagliptin
Intervention · DRUG
Sitagliptin: will be administered as a 100mg dose once daily.
- Metformin HCI XR
Intervention · DRUG
Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.
Study details
- Official title
- Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Conditions
- Type 2 Diabetes (Adult Onset)
- Enrolling
- 256 people
- Starts
- 2024-11-07
- Est. completion
- 2029-06-30
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Positive anti-GAD (antibodies to glutamic acid decarboxylase)
- Pregnancy or plan of becoming pregnant
- Evidence of proliferative diabetic retinopathy,
- Plasma creatinine >1.4 females or >1.5 males;
- Presence of congestive heart failure (CHF);
- History of cancer (<5 years);
- Prior history of pancreatitis,
- Bladder cancer or family history of thyroid tumors;
- Presence of hematuria in the urine analysis.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity Health System Texas Diabetic Institute
San Antonio, Texas, United States
- Muhammad Abdul-Ghani, MD · Contact210-567-2391abdulghani@uthscsa.edu
RecruitingUT Health Science Center
San Antonio, Texas, United States
Recruiting
Study team
Sponsor
The University of Texas Health Science Center at San Antonio
Study ID STUDY00000139
Principal investigator
Muhammad Abdul-Ghani, MD
The University of Texas Health Science Center at San Antonio
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.