About this trial
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 criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Tirzepatide
- Pioglitazone
- Sitagliptin
- Metformin HCI XR
Treatment groups
Sponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator