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

NCT06246799 · Recruiting

Last updated 2026-05-28

This clinical trial compares two different initial combination therapies to see which is more effective at helping adults with recently diagnosed type 2 diabetes lower their blood sugar levels to a target HbA1c of less than 6.5% within six months.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) study

Participants 256 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2024-11 · est. completion 2029-06

Where 2 sites · United States

What this study is testing ClinicalTrials.gov NCT06246799 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide also known as Mounjaro Drug

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.
Pioglitazone also known as Actos Drug

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.
Sitagliptin also known as Januvia Drug

Sitagliptin: will be administered as a 100mg dose once daily.
Metformin HCI XR also known as Extended Release Metformin Drug

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

Main thing measured	number of subjects achieving HbA1c <6.5% at 6 months (Efficacy)
Sponsor	The University of Texas Health Science Center at San Antonio
Conditions studied	Type 2 Diabetes (Adult Onset)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06246799 ↗