RecruitingPhase 3

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

United States256 participantsStarted 2024-11-07

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Ability of subject to understand and the willingness to sign a written informed consent document.
✓. Males and females; Age 18-75 years
✓. Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients
✓. Drug naïve or receiving metformin monotherapy
✓. HbA1c \>6.5% (no limit on upper HbA1c value);
✓. Willingness to adhere to the investigational product regimen
✓. Good general health
✓. Stable body weight over the preceding 3 months

Exclusion criteria

✕. positive anti-GAD (antibodies to glutamic acid decarboxylase)
✕. pregnancy or plan of becoming pregnant
✕. evidence of proliferative diabetic retinopathy,
✕. plasma creatinine \>1.4 females or \>1.5 males;
✕. presence of congestive heart failure (CHF);
✕. history of cancer (\<5 years);
✕. prior history of pancreatitis,

What they're measuring

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

Timeframe: 6 months

Number of subjects failing to achieving HbA1c <6.5% Long-term

Timeframe: month 60

Trial details

NCT IDNCT06246799

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-30

Contact for this trial

Muhammad Abdul-Ghani, MD

210-567-6691 abdulghani@uthscsa.edu

View on ClinicalTrials.gov More Type 2 Diabetes (Adult Onset) trials