Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
The University of Texas Health Science Center at San Antonio
Summary
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.
Description
This is a randomized open label controlled 2 arm study (with one of the arms containing 3 sub-groups) which aims to examine the effectiveness and long term effects on HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus (T2DM) patients. A subgroup of patients from group 1 will be invited to participate in a sub-study which lasts for 6 months and aims at exploring the metabolic/molecular mechanisms responsible for the study results. The selection of subjects to each subgroup will be done ra…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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: 1. positive anti-GAD (ant…
Interventions
- DrugTirzepatide
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.
- DrugPioglitazone
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.
- DrugSitagliptin
Sitagliptin: will be administered as a 100mg dose once daily.
- DrugMetformin HCI XR
Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.
Locations (2)
- University Health System Texas Diabetic InstituteSan Antonio, Texas
- UT Health Science CenterSan Antonio, Texas