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

PHASE3RecruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

November 7, 2024

Primary Completion Date

April 30, 2029

Study Completion Date

June 30, 2029

Conditions
Type 2 Diabetes (Adult Onset)
Interventions
DRUG

Tirzepatide

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.

DRUG

Pioglitazone

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.

DRUG

Sitagliptin

Sitagliptin: will be administered as a 100mg dose once daily.

DRUG

Metformin HCI XR

Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.

Trial Locations (2)

78207

RECRUITING

University Health System Texas Diabetic Institute, San Antonio

78229

RECRUITING

UT Health Science Center, San Antonio

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

The University of Texas Health Science Center at San Antonio

OTHER