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Tirzepatide

Mounjaro, Zepbound, LY3298176

Quick Stats
Studies 183
Trials 100
Recruiting PHASE3 INTERVENTIONAL NCT06246799

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Tirzepatide
Type: DRUG
Description: 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.
Name: Pioglitazone
Type: DRUG
Description: 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.
Name: Sitagliptin
Type: DRUG
Description: Sitagliptin: will be administered as a 100mg dose once daily.
Name: Metformin HCI XR
Type: DRUG
Description: Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.

Primary Outcomes

Measure: number of subjects achieving HbA1c <6.5% at 6 months (Efficacy)
TimeFrame: 6 months
Description: Therapy failure will be determined as HbA1c \>6.5% in two consecutive HbA1c measurements 3 months apart. Time to cumulative incidence of therapy failure curves will be created in subjects receiving pioglitazone/tirzepatide versus subjects receiving metformin/sitagliptin
Measure: Number of subjects failing to achieving HbA1c <6.5% Long-term
TimeFrame: month 60
Description: The failure to achieving HbA1c \<6.5% (Durability) at the end of study in subjects receiving pioglitazone/tirzepatide (Group I) versus metformin/sitagliptin (Group II) in two consecutive HbA1c measurements 3 months apart.

Trial Information

NCT ID

NCT06246799

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

The University of Texas Health Science Center at San Antonio

Last Updated

December 15, 2025