| Trial ID: | L4233 |
| Source ID: | NCT01107717
|
| Associated Drug: |
Metformin\Pioglitazone\Exenatide
|
| Title: |
Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01107717/results
|
| Conditions: |
Diabetes
|
| Interventions: |
DRUG: metformin\pioglitazone\exenatide|DRUG: metformin, glyburide and glargine
|
| Outcome Measures: |
Primary: HbA1c Level, subjects will be followed for 3 years and the HbA1c measured at this time to provide the values for each arm as defined for the primary outcome of the study, at the end of the study (3 years) | Secondary: Treatment Failure, Number of participants with HbA1c\>6.5% at 3 years, 3 years|Percentage of Patients With Reported Hypoglycemic Events, asymptomatic hypoglycemic events with documented PGC \< 60 mg/dl and sympotomatic hypoglycemia, during the entire study (3 years)
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: American Diabetes Association|Amylin Pharmaceuticals, LLC.|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
318
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-01
|
| Completion Date: |
2023-02-03
|
| Results First Posted: |
2024-09-05
|
| Last Update Posted: |
2024-09-05
|
| Locations: |
Texas Diabetes Institute, San Antonio, Texas, 78229-3900, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01107717
|
