EUCTR2009-010224-25-HU进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin, Alone.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 152
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
- •Signed Written Informed Consent
- •1) Subjects must be willing and able to give written informed consent.
- •2) Subjects with a diagnosis of type 2 diabetes mellitus.
- •3) Subjects must be on a stable, BID dosing of at least 1500 mg of metformin IR for = 8 weeks prior to enrollment.
- •4) Subjects must have a A1C = 7.0% and = 10.0% at screening to be randomized.
- •5) Subjects must have a fasting C-peptide = 0.8 ng/mL (0.34 nmol/L) at screening.
- •6) Subjects must have a body mass index = 45.0 kg/m2.
- •7) Men and women, ages 18 to 78 (inclusive).
- •WOCBP must be using an adequate method of contraception to avoid pregnancy
- •throughout the study, and up to 4 weeks after last study drug was taken in such a
- •manner that the risk of pregnancy is minimized.
- •WOCBP include any female who has experienced menarche and who has not
- •undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or
- •bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:
- •Amenorrhea = 12 consecutive months without another cause or,
- •For women with irregular menstrual periods and on hormone replacement therapy
- •(HRT), a documented serum follicle stimulating hormone (FSH) level
- •= 35 mIU/mL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) WOCBP who are unwilling or unable to use an
- •acceptable method to avoid pregnancy for the entire study period and up to 4 weeks
- •after the final dose of study drug.
- •2) Women who are pregnant or breastfeeding.
- •3) Women with a positive urine HCG pregnancy test at randomization or prior to
- •investigational product administration.
- •4) Sexually active fertile men not using effective birth control for the entire study period and up to 4 weeks after last study drug was taken if their partners are WOCBP.
- •5) Symptoms of poorly controlled T2DM including, but not limited to marked polyuria
- •and polydipsia, with a greater than 10% weight loss during the 3 months prior to
- •screening or other signs and symptoms
- •6) History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- •7) Insulin therapy within 1 year of screening (with the exception of insulin therapy
- •during a hospitalization or use in pregnant women with gestational diabetes).
- •8) Significant cardiovascular history defined as:
- •a) History of myocardial infarction, coronary artery or bypass graft(s), valvular
- •disease or repair, unstable angina pectoris, transient ischemic attack, or cerebral
- •vascular event within 3 months prior to entry into the study or,
- •b) Congestive heart failure defined as New York Heart Association (NYHA) stage
- •III or IV and / or known left ventricular ejection fraction = 40%
- •9) History of hemoglobinopathies
- •10) Chronic or repeated intermittent corticosteroid treatment.
- •11) History of unstable or rapidly progressive renal disease.
- •12) History of alcohol or drug abuse within 1 year prior to enrollment.
- •13) Unstable psychiatric disorders.
- •14) 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).
- •15) 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.
- •16) Subjects on a commercial weight loss program with ongoing weight loss, or on an
- •intensive exercise program.
- •17) FPG > 270 mg/dL prior to randomization.
- •18) Active liver disease and/or significant abnormal liver function (defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x ULN and/or serum total bilirubin > 2.0 mg/dL).
- •19) History of positive serologic evidence of current infectious liver disease including
- •anti-HAV (IgM), HbsAg, or anti-HCV. Subjects who may have isolated positive anti
- •HBs may be included.
- •20) Serum creatinine (Scr) = 1.50 mg/dL (133 µmol/L) for male subjects and
- •= 1.40 mg/dL (124 µmol/L) for female subjects.
- •21) Anemia of any etiology defined as hemoglobin = 12.0 g/dL (120 g/L) for men and
- •= 11.0 g/dL (110 g/L) for women.
- •22) Creatinine kinase (CK ) = 3X ULN.
- •23) Subjects that have an abnormal TSH value at screening will be further evaluated by free T4. Subjects with an abnormal T4 will be excluded.
- •24) Clinically significant (CS) abnormalities in any pre-randomization laboratory
- •analyses or ECG that, in the Investigator’s opinion, would preclude randomization.
- •25) Subjects who have contraindications to therapy as outlined in the Saxagliptin
- •Investigator Brochure or local metformin IR package insert.
- •26) Subjects with known contraindications to DPP-IV therapy.
- •27) Treatment with potent systemic cytochrome P450 3A4 (CYP3A4) inducers
- •28) History of administration of any antihyperglycemic therapy (other than metformin IR as applica
研究者
相似试验
进行中（未招募）
1 期
A study to test the efficacy and safety of padsevonil as treatment of focal-onset seizures in adult subjects with drug-resistant epilepsyFocal-Onset SeizuresMedDRA version: 21.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852EUCTR2018-002303-33-BECB Biopharma SR625
招募中
3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate CancerNon-Metastatic Castration-Resistant Prostate Cancernon-spread Castration-Resistant Prostate Cancer10036958NL-OMON54510Aragon Pharmaceuticals, Inc.35
进行中（未招募）
1 期
A study to look at the effect and how safe drug VIS649 is in patients with kidney diseaseEUCTR2019-002531-29-GBVisterra, Inc.144
进行中（未招募）
不适用
Research study testing the safety and tolerability of the investigationaldrug, BMS-708163, compared to placebo (inactive substance) in subjectswith prodromal Alzheimer's DiseaseALZHEIMER DISEASEMedDRA version: 15.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2009-010067-16-SEBristol-Myers Squibb International Corporation540
进行中（未招募）
1 期
A study of safety and efficacy of lenabasum in dermatomyositis patientsEUCTR2018-003273-10-HUCorbus Pharmaceuticals, Inc.150