Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Recruiting · NCT06246799 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Health Science Center at San Antonio
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed across 1 US state.
- University Health System Texas Diabetic Institute - San Antonio, Texas, United States
- UT Health Science Center - San Antonio, Texas, United States