EUCTR2010-024568-16-BE进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 465
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Signed Written Informed Consent
- •a) Freely given informed consent must be obtained prior to clinical trial
- •participation, including informed consent for any screening procedures conducted to establish subject eligibility for the trial. Minor’s parents or legally acceptable representatives must give fully informed written consent. Assent should be obtained according to local regulations and if child is mentally capable.
- •2) Target Population
- •a) Male and female patients 10 years of age, up to 17 years and 30 weeks of age at the time of screening.
- •b) Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria for glucose levels (FPG >7.0 mmol/L [126 mg/dL] or plasma glucose levels 2-hours after 75-mg oral glucose load of >11.1 mmol/L; [200 mg/dL] or a casual plasma > 200 mg/dL with symptoms WHO 1999; WHO 2006; ADA 2010).
- •c) HbA1c = 7.0% and = 10.5% obtained at screening visit followed by
- •randomization HbA1c = 6.5% and = 10.5% obtained during lead in.
- •d) Body weight = 30 kg.
- •e) BMI > 85th percentile.
- •f) Stable dose of metformin (= 1000mg - = 2000mg) for a minimum of 2 months.
- •3) 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. See Section 3.3.3 for the definition of WOCBP. The decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject.
- •b) Women 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 465
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) 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 main study:
- •6 months: insulin (Exceptions: Short-term insulin therapy during
- •hospitalization for causes other than diabetes should be discussed with the Medical Monitor).
- •4 months: thiazolidinediones.
- •2 months: any other antidiabetic treatment including, but not limited to, sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics.
- •Any previous use of DPP4-inhibitor and/or incretin mimetics
- •Exceptions: metformin monotherapy for 2 months or longer
- •b) Current use of weight loss drugs and their use within 3 months of screening.
- •2) Medical History and Concurrent Diseases
- •a) Significant co-morbidity that would preclude participation in the study.
- •b) Previous diagnosis of monogenic etiology of type 2 diabetes such as MODY, genetic disorders with strong associations with insulin resistance/diabetes and/or obesity (Turner’s Syndrome, Prader-Willi),or secondary diabetes (steroid use, Cushing’s disease, acromegaly).
- •c) Significant cardiovascular history.
- •d) History of hemoglobinopathies
- •e) History of unstable or rapidly progressive renal disease.
- •f) History of alcohol or drug abuse.
- •g) Psychiatric cognitive disorder that will limit the patient’s ability to comply with the study.
- •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 may render the subject unable to complete the study or may pose significant risk.
- •j) Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with HIV
- •k) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program.
- •3) Physical and Laboratory Test Findings
- •a) FPG > 255 mg/dL (14.2 mmol/L) at screening
- •b) DKA within 6 months of study entry
- •c) Abnormal renal function, defined as an abnormal creatinine clearance rate.
- •d) Presence of one or more of the following: antibodies to GAD, ICA or IA-2.
- •e) Active liver disease and/or significant abnormal liver function defined as AST and/or 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 for females and = 11.3 g/dL 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) CK = 3X 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) Contraindications to therapy defined in the Saxagliptin IB or local metformin package insert.
- •b) Subjects with known contraindications to DPP-IV therapy.
- •5) Prohibited Therapies and/or Medications
- •a) Steroid use exclusions:
- •Excluded: oral or parenteral corticosteroids within 3 months
- •Allowed: inhaled corticosteroids for asthma, and topical corticosteroids if limited to minor surface area.
- •b) Use of any othe
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