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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024568-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Saxagliptin +Metformin XR/IR | Experimental | Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg |
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| Arm 2: Placebo +Metformin XR/IR | Placebo Comparator | Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo matching with Saxagliptin | Drug | Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52 |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in HbA1c From Baseline to Week 16 | 16 week short term treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | United States | |||
| Research Site |
Of 32 subjects enrolled, 7 subjects entered the lead-in period. Of these 7 subjects, 6 were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matching saxagliptin |
| FG001 | Saxagliptin | saxagliptin 2.5 or 5 mg according to body weight |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Metformin IR | Drug | Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52 |
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| Metformin XR | Drug | Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52 |
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| Saxagliptin | Drug | Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) |
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| Tallahassee |
| Florida |
| United States |
| Research Site | Dearborn | Michigan | United States |
| Research Site | Saint Paul | Minnesota | United States |
| Research Site | Mineola | New York | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Namur | Belgium |
| Research Site | Calgary | Alberta | Canada |
| Research Site | Bangalore | India |
| Research Site | Aguascalientes | Mexico |
| Research Site | Meridas | Mexico |
| Research Site | Monterrey | Mexico |
| Research Site | Veracruz | Mexico |
| Research Site | Taichung | Taiwan |
| Research Site | Leicester | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matching saxagliptin |
| BG001 | Saxagliptin | saxagliptin 2.5 or 5 mg according to body weight |
| 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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| 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 | Mean Change in HbA1c From Baseline to Week 16 | Posted | Mean | Standard Deviation | percentage | 16 week short term treatment period |
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52 week
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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 | Placebo | Placebo matching saxagliptin | 0 | 2 | 1 | 2 | ||
| EG001 | Saxagliptin | saxagliptin 2.5 or 5 mg according to body weight | 0 | 4 | 4 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pharyngitis Streptococcal | Infections and infestations | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Pharyngitis bacterial | Infections and infestations | Systematic Assessment |
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| LACERATION | Injury, poisoning and procedural complications | Systematic Assessment |
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| URINE OUTPUT INCREASED | Investigations | Systematic Assessment |
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| MENSTRUATION IRREGULAR | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Johnsson, Clinical Science Lead, GLOBAL_MEDICINES_DEV | AstraZeneca AB, S-151 85 Södertälje, Sweden | +46 31 7762484 | 762 484 | Eva.Johnsson@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 |
|---|---|
| C502994 | saxagliptin |
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| >=65 years |
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| Male |
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