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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center at San Antonio

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

256 Participants
are divided into 4 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