Clinical trial NCT06246799: Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Official title: Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes (Adult Onset)
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-02-07
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized open label study. There are 2 groups, with 2 sub groups, 1A, 1B and 1C included within Group 1.
Primary purpose: OTHER

Brief 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.

Detailed description: This is a randomized open label controlled 2 arm study (with one of the arms containing 3 sub-groups) which aims to examine the effectiveness and long term effects on HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus (T2DM) patients.

A subgroup of patients from group 1 will be invited to participate in a sub-study which lasts for 6 months and aims at exploring the metabolic/molecular mechanisms responsible for the study results. The selection of subjects to each subgroup will be done randomly and the end of sub-study, subjects will continue therapy and follow-up from month 6 on in the main study.

Eligibility 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.

Primary outcomes:
measure: number of subjects achieving HbA1c <6.5% at 6 months (Efficacy)
timeFrame: 6 months
measure: Number of subjects failing to achieving HbA1c <6.5% Long-term
timeFrame: month 60
Secondary outcomes:
measure: Change in insulin sensitivity
timeFrame: from baseline to end of study (60 months)
measure: Change in Beta Cell Function
timeFrame: Baseline to end of study (60 months)
measure: Change in body weight
timeFrame: Baseline to end of study (60 months)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Health System Texas Diabetic Institute
state: Texas
city: San Antonio
country: United States
facility: UT Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Muhammad Abdul-Ghani, MD
role: PRINCIPAL_INVESTIGATOR
References: