| Trial ID: | L5536 |
| Source ID: | NCT06246799
|
| Associated Drug: |
Tirzepatide
|
| Title: |
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes (Adult Onset)
|
| Interventions: |
DRUG: Tirzepatide|DRUG: Pioglitazone|DRUG: Sitagliptin|DRUG: Metformin HCI XR
|
| Outcome Measures: |
Primary: number of subjects achieving HbA1c <6.5% at 6 months (Efficacy), 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, 6 months|Number of subjects failing to achieving HbA1c <6.5% Long-term, 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., month 60 | Secondary: Change in insulin sensitivity, Matsuda Index of insulin sensitivity or total glucose disposal measured with the clamp.These are the gold standard methods for quantification insulin sensitivity with the OGTT or a euglycemic clamp, from baseline to end of study (60 months)|Change in Beta Cell Function, A calculated value using plasma glucose, insulin and C-peptide concentrations during the Oral Glucose Tolerance Test (OGTT) test., Baseline to end of study (60 months)|Change in body weight, Change from study beginning to end, measured in kilograms (kg), Baseline to end of study (60 months)
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
256
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2024-11-07
|
| Completion Date: |
2029-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-24
|
| Locations: |
University Health System Texas Diabetic Institute, San Antonio, Texas, 78207, United States|UT Health Science Center, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06246799
|
