Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
The University of Texas Health Science Center at San Antonio
256 participants
Nov 7, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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.
Exclusion Criteria9
- 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.
Interventions
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: 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: will be administered as a 100mg dose once daily.
Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06246799