Find-A-Study

Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes

Lay Description

The goal of this randomized, open labelled clinical trial is to examine the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus patients.
The main question[s] it aims to answer are:
How effective is the combination of pioglitazone plus tirzepatide in managing blood sugar levels in people with type 2 diabetes?
How does this combination compare to the use of metformin plus sitagliptin in controlling blood sugar levels?

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts 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 (antibodies to glutamic acid decarboxylase) 2. pregnancy or plan of becoming pregnant 3. evidence of proliferative diabetic retinopathy, 4. plasma creatinine >1.4 females or >1.5 males; 5. presence of congestive heart failure (CHF); 6. history of cancer (<5 years); 7. prior history of pancreatitis, 8. bladder cancer or family history of thyroid tumors; 9. presence of hematuria in the urine analysis.

Study Design

Arm Groups

Study Contact

Gozde Baskoy
210-358-7200
baskoy@uthscsa.edu

Andrea Hansis-Diarte
210-567-3208
hansisdiarte@uthscsa.edu

Erwin Nepomuceno

nepomucenoe@uthscsa.edu