| Trial ID: | L6793 |
| Source ID: | NCT01154933
|
| Associated Drug: |
Exenatide 5 Mcg
|
| Title: |
Exeantide in Type 2 Diabetes on Insulin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01154933/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: exenatide 5 mcg|DRUG: exenatide 10 mcg|DRUG: placebo
|
| Outcome Measures: |
Primary: Fasting Insulin, To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients., after 24 hours fast at baseline and 12 weeks | Secondary: Weight, To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients, value at 12 weeks minus value at baseline|HbA1c, To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients., value at 12 weeks minus value at baseline|Intranuclear NFκB Binding Activity, Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group, measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline
|
| Sponsor/Collaborators: |
Sponsor: University at Buffalo | Collaborators: Amylin Pharmaceuticals, LLC.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-04
|
| Completion Date: |
2011-11
|
| Results First Posted: |
2022-10-06
|
| Last Update Posted: |
2022-10-06
|
| Locations: |
Millard Fillmore Gates Hospital, Buffalo, New York, 14209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01154933
|
