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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide:Treatment-Emergent Antibody Negative | Experimental | This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. |
|
| Exenatide:Treatment-Emergent Antibody Positive | Experimental | This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection, 5mcg or 10mcg, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Antibody Status (Maximum Titer Level Experienced) | Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced) | 24 weeks |
| Incidence of Potentially Immune-related Treatment-emergent Adverse Events | Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status | 24 weeks |
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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 | Keswick | South Australia | Australia | |||
| Research Site |
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Following a period of treatment interruption of at least 2 months, patients for this study were recruited from among patients who were previously exposed to exenatide for at least 3 months in Amylin/Lilly studies GWAO, GWAP, GWAT, and GWBA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide:Treatment-Emergent Antibody Negative | 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study. |
| FG001 | Exenatide: Treatment-Emergent Antibody Positive |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Calgary |
| Alberta |
| Canada |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Budapest | Hungary |
| Research Site | Gyula | Hungary |
| Research Site | Zalaegerszeg | Hungary |
| Research Site | Milan | Italy |
| Research Site | Perugia | Italy |
| Research Site | Rome | Italy |
| Research Site | Seonnam City | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Suwon | South Korea |
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study. |
| FG002 | Enrolled But Withdrew Before Receiving Treatment | No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Baseline (Week 0) Antibody Status | Patients assessed as negative for antibodies to exenatide at baseline (Week 0). |
| BG001 | Positive Baseline (Week 0) Antibody Status | Patients assessed as positive for antibodies to exenatide at baseline (Week 0). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Treatment-emergent Antibody Status (Maximum Titer Level Experienced) | Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced) | Intent to Treat | Posted | Number | Participants | 24 weeks |
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| Secondary | Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status | Intent to Treat; Last Observation Carried Forward | Posted | Mean | Standard Deviation | percent | 24 weeks |
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| Primary | Incidence of Potentially Immune-related Treatment-emergent Adverse Events | Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study | Intent to Treat | Posted | Number | participants | 24 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:Treatment-Emergent Antibody Negative | 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study. | 0 | 7 | ||||
| EG001 | Exenatide: Treatment-Emergent Antibody Positive | 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study. | 1 | 11 | ||||
| EG002 | Enrolled But Withdrew Before Receiving Treatment | No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted. | 1 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Injection site pruritis | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Gastrooesphageal reflux disease | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Periodontitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Ohman, Medical Science Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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| >=65 years |
|
| Male |
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| Title | Measurements |
|---|---|
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| Higher titer antibodies |
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| Participants |
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