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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide Arm | Experimental | This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study. |
|
| Placebo Arm | Placebo Comparator | This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection, 5mcg or 10mcg, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Halifax | Nova Scotia | Canada | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20109208 | Derived | Gill A, Hoogwerf BJ, Burger J, Bruce S, Macconell L, Yan P, Braun D, Giaconia J, Malone J. Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study. Cardiovasc Diabetol. 2010 Jan 28;9:6. doi: 10.1186/1475-2840-9-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide BID | 5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study. |
| FG001 | Placebo | Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide BID | 5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study. |
| BG001 | Placebo | Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat; Last observation carried forward | Posted | Least Squares Mean | Standard Error | beats per minute | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide BID | 5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Ohman, Medical Science Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| placebo | Drug | subcutaneous injection, volume equivalent to active, twice a day |
|
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 |
| Toronto |
| Ontario |
| Canada |
| Research Site | Etten-Leur | Netherlands |
| Research Site | Leiden | Netherlands |
| Research Site | Rotterdam | Netherlands |
| Research Site | Utrecht | Netherlands |
| Loss of Glucose Control |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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|
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| 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 | Intent to treat; Last observation carried forward | Posted | Least Squares Mean | Standard Error | beats per minute | 12 weeks |
|
|
|
|
| Secondary | 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 | Intent to treat; Last observation carried forward | Posted | Least Squares Mean | Standard Error | beats per minute | 12 weeks |
|
|
|
|
| Secondary | 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 | Intent to treat; Last observation carried forward | Posted | Least Squares Mean | Standard Error | mmHg | 12 weeks |
|
|
|
|
| Secondary | 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 | Intent to treat; Last observation carried forward | Posted | Least Squares Mean | Standard Error | mmHg | 12 weeks |
|
|
|
|
| Secondary | Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Change from baseline to endpoint in HbA1c | Intent to treat; Last observation carried forward | Posted | Least Squares Mean | Standard Error | percent | 12 weeks |
|
|
|
|
| 1 |
| 18 |
| EG001 | Placebo | Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm). | 1 | 21 |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Restlessness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| D004700 | Endocrine System Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |