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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection, 5mcg or 10mcg, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k). | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin. | baseline, Week 24 |
| Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Malone, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Peoria | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22913891 | Derived | Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567. |
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One randomized patient per group discontinued before receiving study drug. These patients are not included in the "started" category below.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks |
| FG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks |
| BG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks |
| 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 From Baseline in Body Weight | Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k). | Intent to Treat population | Posted | Least Squares Mean | Standard Error | kg | Baseline, Week 24 |
|
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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 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis bacterial | Gastrointestinal disorders | 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 |
| D003920 | Diabetes Mellitus |
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| 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 |
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| placebo | Drug | subcutaneous injection, volume equivalent to exenatide dose, twice a day |
|
Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L). |
| baseline, Week 24 |
| Change From Baseline in Waist Circumference at Week 24 | Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm). | baseline, Week 24 |
| Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline | Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant. | baseline, Week 24 |
| Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline | Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant. | baseline, Week 24 |
| Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24 | Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L. | baseline, Week 24 |
| Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24 | Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L | baseline, Week 24 |
| Change From Baseline in Total Cholesterol at Week 24 | Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L. | baseline, week 24 |
| Ratio of Triglycerides at Week 24 to Triglycerides at Baseline | Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L. | baseline, Week 24 |
| Number of Participants With Hypoglycemic Events During the Study | Number of participants experiencing one or more events of hypoglycemia at any point in the study | Baseline to 24 weeks |
| Rate of Hypoglycemic Events | Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year). | 24 weeks |
| Jacksonville |
| Florida |
| United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Spartanburg | South Carolina | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Renton | Washington | United States |
| Loss of Glucose Control |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline Body Weight | Mean | Standard Deviation | kg |
|
| Baseline Cholesterol | Mean | Standard Deviation | mmol/L |
|
| Baseline Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percent hemoglobin |
|
| Baseline High Density Lipoprotein (HDL) Cholesterol | Mean | Standard Deviation | mmol/L |
|
| Baseline Homeostatic Model Assessment-Beta Cell (HOMA-B) | Mean | Standard Deviation | Percent beta-cell function |
|
| Baseline Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) | Mean | Standard Deviation | Percent insulin sensitivity |
|
| Baseline Low Density Lipoprotein (LDL) Cholesterol | Mean | Standard Deviation | mmol/L |
|
| Baseline Triglycerides | Mean | Standard Deviation | mmol/L |
|
| Baseline Waist Circumference | Mean | Standard Deviation | cm |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin. | Intent to Treat population | Posted | Least Squares Mean | Standard Error | percent hemoglobin | baseline, Week 24 |
|
|
|
|
| Secondary | Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24 | Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L). | Intent to Treat population | Posted | Least Squares Mean | Standard Error | mmol/L | baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in Waist Circumference at Week 24 | Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm). | Intent to Treat population | Posted | Least Squares Mean | Standard Error | cm | baseline, Week 24 |
|
|
|
|
| Secondary | Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline | Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant. | Intent to Treat population | Posted | Geometric Mean | Standard Error | Ratio | baseline, Week 24 |
|
|
|
|
| Secondary | Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline | Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant. | Intent to Treat population | Posted | Geometric Mean | Standard Error | Ratio | baseline, Week 24 |
|
|
|
|
| Secondary | Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24 | Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L. | Intent to Treat population | Posted | Least Squares Mean | Standard Error | mmol/L | baseline, Week 24 |
|
|
|
|
| Secondary | Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24 | Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L | Intent to Treat population | Posted | Least Squares Mean | Standard Error | mmol/L | baseline, Week 24 |
|
|
|
|
| Secondary | Change From Baseline in Total Cholesterol at Week 24 | Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L. | Intent to Treat population | Posted | Least Squares Mean | Standard Error | mmol/L | baseline, week 24 |
|
|
|
|
| Secondary | Ratio of Triglycerides at Week 24 to Triglycerides at Baseline | Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L. | Intent to Treat population | Posted | Geometric Mean | Standard Error | Ratio | baseline, Week 24 |
|
|
|
|
| Secondary | Number of Participants With Hypoglycemic Events During the Study | Number of participants experiencing one or more events of hypoglycemia at any point in the study | Intent to Treat population | Posted | Number | participants | Baseline to 24 weeks |
|
|
|
|
| Secondary | Rate of Hypoglycemic Events | Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year). | Intent to Treat population | Posted | Least Squares Mean | Standard Error | events per patient per year | 24 weeks |
|
|
|
|
| 2 |
| 87 |
| EG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks | 2 | 82 |
| Hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| Midday Pre-Meal |
|
| 2 Hours Post Midday Meal |
|
| Evening Pre-Meal |
|
| 2 Hours Post Evening Meal |
|