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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Muhammad Abdul-Ghani, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
Who to contact
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What this trial measures
- 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.