TrialGlobe

Clinical trial

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

Recruiting now · Phase 3 · 1 countries · Registry ID NCT06246799

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes (Adult Onset)

Full registry criteria

Inclusion Criteria: 1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Males and females; Age 18-75 years 3. Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients 4. Drug naïve or receiving metformin monotherapy 5. HbA1c \>6.5% (no limit on upper HbA1c value); 6. Willingness to adhere to the investigational product regimen 7. Good general health 8. Stable body weight over the preceding 3 months 9. Agreement to adhere to Lifestyle Considerations throughout study duration. Exclusion Criteria: 1. positive anti-GAD (antibodies to glutamic acid decarboxylase) 2. pregnancy or plan of becoming pregnant 3. evidence of proliferative diabetic retinopathy, 4. plasma creatinine \>1.4 females or \>1.5 males; 5. presence of congestive heart failure (CHF); 6. history of cancer (\<5 years); 7. prior history of pancreatitis, 8. bladder cancer or family history of thyroid tumors; 9. presence of hematuria in the urine analysis.

Treatments and study arms

Tirzepatide

Drug

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.

Pioglitazone

Drug

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.

Sitagliptin

Drug

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

Metformin HCI XR

Drug

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

Primary outcomes

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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

UT Health Science Center🇺🇸 San Antonio, Texas, United States
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University Health System Texas Diabetic Institute🇺🇸 San Antonio, Texas, United States
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Muhammad Abdul-Ghani, MDContact
Email · Call 210-567-2391