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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020360-38 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin | Experimental | Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) |
|
| Placebo | Placebo Comparator | Placebo matching saxagliptin tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks |
|
| 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:
Age and Reproductive Status a) Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. The decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject.
b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product. c) Women must not be breastfeeding. d) Sexually active fertile men must use effective birth control if their partners are WOCBP.
Exclusion Criteria:
Target Disease Exceptions
a) Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the study: i) Six months: insulin. ii) Four months: thiazolidinediones. iii) Two months: any other antidiabetic treatment iv) Any previous use of DPP4-inhibitor and/or incretin mimetics b) Current use of prescription or non-prescription weight loss drugs and their use within 3 months of screening.
Medical History and Concurrent Diseases
a) Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (eg, current treatment for cancer). b) Previous diagnosis of monogenic etiology of type 2 diabetes such as MODY (maturity onset of diabetes in youth) or secondary diabetes (steroid use, Cushing's disease, acromegaly). c) Significant cardiovascular history. d) History of hemoglobinopathies (sickle cell anemia or thalassemias, sideroblastic anemia). e) History of unstable or rapidly progressive renal disease. f) History of alcohol or drug abuse. g) Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the patient's ability to comply with the study medications and monitoring. h) Administration of any other study drug or participation in a clinical research trial within 30 days of planned enrollment to this study (or a longer period if dictated by local regulatory authorities). i) Any condition, which in the investigator's opinion may render the subject unable to complete the study or may pose significant risk to the subject. j) Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus. k) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program.
Physical and Laboratory Test Findings a) Fasting plasma glucose (FPG) > 255 mg/dL (14.2 mmol/L) at screening will exclude the patient. b) Diabetic ketoacidosis (DKA) within 6 months of study entr1) Target Disease Exceptions a) Current use of the following medications : i) Six months: insulin. ii) Four months: thiazolidinediones. iii) Two months: any other antidiabetic treatment iv) Any previous use of DPP4-inhibitor and/or incretin mimetics b) Current use of prescription or non-prescription weight loss drugs and their use within 3 months of screening.
2) Medical History and Concurrent Diseases
a) Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (eg, current treatment for cancer). b) Previous diagnosis of monogenic etiology of type 2 diabetes such as MODY (maturity onset of diabetes in youth) or secondary diabetes (steroid use, Cushing's disease, acromegaly). c) Significant cardiovascular history. d) History of hemoglobinopathies (sickle cell anemia or thalassemias, sideroblastic anemia). e) History of unstable or rapidly progressive renal disease. f) History of alcohol or drug abuse. g) Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the patient's ability to comply with the study medications and monitoring. h) Administration of any other study drug or participation in a clinical research trial within 30 days of planned enrollment to this study (or a longer period if dictated by local regulatory authorities). i) Any condition, which in the investigator's opinion may render the subject unable to complete the study or may pose significant risk to the subject. j) Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus. k) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program. 3) Physical and Laboratory Test Findings
Exclusion from study participation will apply to calculated glomerular filtration rate < 80 mL/min/1.73m2 (1.33 mL/s). d) Presence of one or more of the following: antibodies to glutamic acid decarboxylase (GAD), islet cell autoantibody (ICA), protein tyrosine phosphatase-like protein antibodies (IA-2). e) Active liver disease and/or significant abnormal liver function defined as Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times upper limits of normal, and/or serum total bilirubin > 2.0 mg/dL. f) History of positive serologic evidence of current infectious liver disease including anti-HAV (IgM), HbsAg, or anti-HCV. Patients who may have isolated positive anti HBs may be included. g) Anemia of any etiology defined as hemoglobin ≤ 10.7 g/dL (107 g/L) for females and ≤ 11.3 g/dL (113 g/L) for males. h) An abnormal TSH value at screening will be further evaluated by free T4. Subjects with an abnormal T4 will be excluded. i) Creatinine kinase (CK) ≥ 3 X ULN. j) Clinically significant (CS) abnormalities in any pre-randomization laboratory analyses or ECG that, in the investigator's opinion, would preclude randomization. 4) Allergies and Adverse Drug Reaction
a) Steroid use exclusions: i) Excluded: use of oral or parenteral corticosteroids within 3 months ii) Allowed: inhaled corticosteroids for asthma, and topical corticosteroids if limited to minor surface area. b) Use of any other antihyperglycemic medication (other than metformin or insulin as applicable for glycemic rescue) after entry into the placebo lead-in period. c) Prior treatment with saxagliptin. d) Subjects taking prohibited medication as listed in Section 3.4. Subjects who stop prohibited medication prior to study participation must undergo an appropriate wash out period before visit 1. e) Diabetes treatment or use of weight loss medications f) Current treatment with potent CYP3A4/5 inhibitors (in countries where dose adjustment would be required by the saxagliptin label). 6) Sex and Reproductive Status
a) Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding. 7) Other 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 26 subjects enrolled, 12 subjects entered the lead in period. Of these 12 subjects, 8 subjects were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Saxagliptin | Saxagliptin 2.5 mg or 5 mg depending on body weight |
| FG001 | Placebo | Placebo matching saxagliptin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo (Saxagliptin) | Drug | Tablets, Oral, Once daily, 1-16 weeks |
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| Metformin IR | Drug | Tablets, Oral, 500 mg, Once Daily, 17-52 weeks |
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| Placebo (Metformin) | Drug | Tablets, Oral, Once daily, 1-16 weeks |
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| Metformin (Active Rescue) | Drug | Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks |
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| San Diego |
| California |
| United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Tallahassee | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Dearborn | Michigan | United States |
| Research Site | Buffalo | New York | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Moscow | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Cape Town | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Taichung | Taiwan |
| Research Site | Taipei | Taiwan |
| Double-blind Treatment Period |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Saxagliptin | Saxagliptin 2.5 mg or 5 mg depending on body weight |
| BG001 | Placebo | Placebo matching saxagliptin |
| 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 |
| ||||||||||||||||||
| 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
16 week double-blind treatment period and 36 week long-term extension period
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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 | 1 | 4 | 3 | 4 | ||
| EG001 | Saxagliptin | Saxagliptin 2.5 mg or 5 mg depending on body weight | 0 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | Non-systematic Assessment |
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| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Non-systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| HYPERNATRAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
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| ONYCHOLYSIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Non-systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | Non-systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| VISION BLURRED | Eye disorders | Non-systematic Assessment |
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| THERMAL BURN | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | Non-systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| PERIPHERAL SWELLING | General disorders | Non-systematic Assessment |
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| JOINT SWELLING | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| WHEEZING | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Non-systematic Assessment |
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| LACERATION | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| INFLUENZA | Infections and infestations | Non-systematic Assessment |
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| LYMPHADENOPATHY | Blood and lymphatic system disorders | Non-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 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
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