Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.
A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bydureon | Experimental | Once weekly injected exenatide |
|
| Placebo | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bydureon | Drug | Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Mean Weighted Glucose | Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70). | Day 27/28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient | Day 64/65 | |
| Change From Baseline (Day1) to Day 70 and Day 22 in FPG | Day 22/Day70 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | United States | |||
| Research Site |
239 subjects were screened in order to randomize 117 subjects; however, 116 subjects were included in the modified intent to treat population, which consisted of all randomized patients who received at least one dose of randomized study drug.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Once Weekly (EQW) + Met | Bydureon EQW + Metformin XR 1500-2000 mg |
| FG001 | Placebo + Met | Placebo + Metformin 1500 + 2000 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo |
|
| Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal) | Day 22 and Day 64 |
| Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10 | Week 4 and Week 10 |
| Change in HbA1c From Baseline to Day 22 and Baseline to Day 70 | Day 22 and Day 70 |
| Chino |
| California |
| United States |
| Research Site | Los Angeles | California | United States |
| Research Site | North Hollywood | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Spring Valley | California | United States |
| Research Site | Tustin | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Port Orange | Florida | United States |
| Research Site | Marietta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Edina | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Butte | Montana | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Franklin | Ohio | United States |
| Research Site | Marion | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Mt. Pleasant | South Carolina | United States |
| Research Site | Rapid City | South Dakota | United States |
| Research Site | Corpus Christi | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Katy | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Burke | Virginia | United States |
| Research Site | Manassas | Virginia | United States |
| Research Site | Olympia | Washington | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
239 subjects were screened in order to randomize 117 subjects; however, 116 subjects were included in the modified intent to treat population, which consisted of all randomized patients who received at least one dose of randomized study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Once Weekly (EQW) + Met | Bydureon EQW + Metformin XR 1500-2000 mg |
| BG001 | Placebo + Met | Placebo + Metformin 1500 + 2000 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Gender | Count of Participants | 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 24-hour Mean Weighted Glucose | Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70). | Posted | Mean | Standard Deviation | (mg/dL) | Day 27/28 | (mg/dL) | (mg/dL) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient | Posted | Least Squares Mean | Standard Error | mg/dL | Day 64/65 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day1) to Day 70 and Day 22 in FPG | Posted | Least Squares Mean | Standard Error | mg/dL | Day 22/Day70 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal) | Posted | Least Squares Mean | Standard Error | mg/dL | Day 22 and Day 64 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10 | Posted | Least Squares Mean | Standard Error | mg/dL | Week 4 and Week 10 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Day 22 and Baseline to Day 70 | Posted | Least Squares Mean | Standard Error | % Alc | Day 22 and Day 70 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10 | Posted | Least Squares Mean | Standard Error | % times patients had specific CGM/24-hr | Week 4 and Week 10 |
|
|
18 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EQW + Met | Bydureon EQW + Metformin 1500-2000 mg | 4 | 60 | 35 | 60 | ||
| EG001 | Placebo + Met | Placebo + Metformin 1500 + 2000 mg | 1 | 56 | 26 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Non-Cardiac Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Acute Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Vulvovaginal mycotic infection | Infections and infestations | Non-systematic Assessment |
| ||
| Injection site induration | General disorders | Non-systematic Assessment |
| ||
| Injection site nodule | General disorders | Non-systematic Assessment |
| ||
| Edema peripheral | General disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lipase increased | Investigations | Non-systematic Assessment |
| ||
| Amylase increased | Investigations | Non-systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Glycosuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
Institution & PI agree they will not use or disclose and confidential information to third parties for a period of 10 years from receipt.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sergey Zhuplatov MD, PhD | AstraZeneca, PLL | 215-542-3222 | Sergey.Zhuplatov@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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| Change from Baseline to Day 27/28 |
|
| Change from Baseline to Day 69/70 |
|
|
|
|
|
|
|