NCT06246799

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a randomized open label controlled 2 arm study (with one of the arms containing 3 sub-groups) which aims to examine the effectiveness and long term effects on HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus (T2DM) patients. A subgroup of patients from group 1 will be invited to participate in a sub-study which lasts for 6 months and aims at exploring the metabolic/molecular mechanisms responsible for the study results. The selection of subjects to each subgroup will be done randomly and the end of sub-study, subjects will continue therapy and follow-up from month 6 on in the main study.

Conditions

• Type 2 Diabetes (Adult Onset)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-07
• Primary completion: 2029-04-30
• Completion: 2029-06-30
• First posted: 2024-02-07
• Last updated: 2026-03-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study