| Trial ID: | L2396 |
| Source ID: | NCT00516074
|
| Associated Drug: |
Exenatide
|
| Title: |
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00516074/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: exenatide|DRUG: placebo
|
| Outcome Measures: |
Primary: Change in Mean 24-hour Heart Rate From Baseline to Endpoint, Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor., 12 weeks | Secondary: Change in Daytime Heart Rate From Baseline to Endpoint, Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor, 12 weeks|Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint, Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor, 12 weeks|Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint, Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor, 12 weeks|Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint, Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor, 12 weeks|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint, Change from baseline to endpoint in HbA1c, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-09
|
| Completion Date: |
2008-04
|
| Results First Posted: |
2009-06-12
|
| Last Update Posted: |
2015-04-07
|
| Locations: |
Research Site, Halifax, Nova Scotia, Canada|Research Site, Toronto, Ontario, Canada|Research Site, Etten-Leur, Netherlands|Research Site, Leiden, Netherlands|Research Site, Rotterdam, Netherlands|Research Site, Utrecht, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT00516074
|
