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

NCT06246799 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2026-03-10

No results posted yet for this study

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.

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.

Sponsors & Collaborators

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

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Muhammad Abdul-Ghani, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-07
Primary Completion
2029-04-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06246799 on ClinicalTrials.gov