Comparing Treatments for Recent Onset Type 2 Diabetes

This study is comparing two different combinations of medicines for people recently diagnosed with type 2 diabetes. One combination is pioglitazone and tirzepatide, and the other is metformin and sitagliptin. The goal is to see which combination is better at lowering your HbA1c (a measure of blood sugar control) to below 6.5% after 6 months, and how well these effects last over 5 years. You might be able to join if you are 18-75 years old, were diagnosed with type 2 diabetes within the last 5 years, and are either new to diabetes medication or only taking metformin. The study plans to enroll 256 participants.

Study design
This is a randomized, open-label study with two main groups, one of which has three subgroups. It aims to enroll 256 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 60 months (5 years) to see the long-term effects of the treatments.

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NCT06246799

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

Recruiting
PHASE3Ages 18–75Interventional
The University of Texas Health Science Center at San Antonio
~256 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:TirzepatidePioglitazoneSitagliptinMetformin HCI XR

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
number of subjects achieving HbA1c <6.5% at 6 months (Efficacy)
Measured over 6 months
+1 more outcome measured
Type 2 Diabetes (Adult Onset)
2 sites across 1 states
Texas2
  • Muhammad Abdul-Ghani, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

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  • number of subjects achieving HbA1c <6.5% at 6 months (Efficacy)6 months

    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

  • Number of subjects failing to achieving HbA1c <6.5% Long-termmonth 60

    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.