A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00516074
First received: August 10, 2007
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
This study will explore the effect of exenatide (given twice a day) versus placebo (given twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug exposure in patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: exenatide Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- Change in Mean 24-hour Heart Rate From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.
Secondary Outcome Measures:
- Change in Daytime Heart Rate From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor
- Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor
- Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor
- Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor
- Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change from baseline to endpoint in HbA1c
| Enrollment: | 54 |
| Study Start Date: | September 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exenatide Arm
This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.
|
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Names:
|
|
Placebo Comparator: Placebo Arm
This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).
|
Drug: placebo
subcutaneous injection, volume equivalent to active, twice a day
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with type 2 diabetes.
- Treated with metformin and/or a thiazolidinedione.
- HbA1c between 6.5% and 9.5%, inclusive.
- Body Mass Index (BMI) > 25 kg/m^2 and < 40 kg/m^2.
Exclusion Criteria:
- Have previously received exenatide or glucagon-like peptide-1 analogs.
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
- Receiving beta blockers.
- Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
- Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.
- Have been treated with drugs that promote weight loss (for example, Adipex® [phentermine], Acomplia® [rimonabant], Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
- Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: *Insulin; *Alpha-glucosidase inhibitors (for example, Glyset® [miglitol] or Precose® [acarbose]); *Meglitinides (for example, Prandin® [repaglinide] or Starlix® [nateglinide]); *Sulfonylureas (for example, Glucotrol® [glipizide] or Micronase® [glyburide]); *Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ [sitagliptin])
- Have donated blood within 60 days of screening.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516074
Locations
| Canada, Nova Scotia | |
| Research Site | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Research Site | |
| Toronto, Ontario, Canada | |
| Netherlands | |
| Research Site | |
| Etten-Leur, Netherlands | |
| Research Site | |
| Leiden, Netherlands | |
| Research Site | |
| Rotterdam, Netherlands | |
| Research Site | |
| Utrecht, Netherlands | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | Chief Medical Officer, MD | Eli Lilly and Company |
More Information
No publications provided by Amylin Pharmaceuticals, LLC.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT00516074 History of Changes |
| Other Study ID Numbers: | H8O-MC-GWCD |
| Study First Received: | August 10, 2007 |
| Results First Received: | April 24, 2009 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Canada: Health Canada Netherlands: Dutch Health Care Inspectorate |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
exenatide Byetta type 2 diabetes |
heart rate Amylin Lilly |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013