RecruitingPhase 3NCT06246799

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


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

256 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two different two-drug combination therapy approaches as a starting treatment for people newly diagnosed with type 2 diabetes. It aims to find out which combination approach is better at controlling blood sugar long-term while minimizing side effects. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with type 2 diabetes within the past 5 years - You are either untreated or only taking metformin - Your HbA1c (a measure of blood sugar over 3 months) is above 6.5% - Your weight has been stable for the past 3 months - You are in generally good health **You may NOT be eligible if...** - You have type 1 diabetes (positive anti-GAD antibodies) - You are pregnant or planning to become pregnant - You have advanced diabetic eye disease (proliferative retinopathy) - You have significant kidney problems (high creatinine) - You are already on multiple diabetes medications beyond metformin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

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.

DRUGPioglitazone

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.

DRUGSitagliptin

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

DRUGMetformin HCI XR

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


Locations(2)

University Health System Texas Diabetic Institute

San Antonio, Texas, United States

UT Health Science Center

San Antonio, Texas, United States

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NCT06246799