EUCTR2011-003971-12-ES进行中（未招募）1 期
A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus? in Subjects With Type 1 Diabetes Mellitus.
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
- 500
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. Subject has had T1DM for at least one year prior to Visit 1 and has a Visit 1 C-peptide ?0.7 ng/mL (0.23 nmol/L) when plasma glucose is >90 mg/dL (5 mmol/L).
- •2. Subject currently on a regimen of basal insulin and has been using rDNA origin prandial insulin (i.e. lispro, aspart, glulisine) for a total duration of ?4 weeks.
- •3. Subject is ?18 years of age on day of signing informed consent.
- •4. Subject has a Visit 1/Screening A1C of ?11.0%.
- •5. Subject has a body mass index (BMI) <45 kg/m2.
- •6. Subject is a male, or a female who is highly unlikely to conceive as indicated by meeting at least one of the following criteria:
- •-Subject is not of reproductive potential. A female subject who is not of
- •reproductive potential is defined as one who has either (1) reached natural menopause (defined as ?12 months of spontaneous amenorrhea in women >45 years of age, or ?6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory), or (2) had bilateral oophorectomy and/or hysterectomy, or had bilateral tubal ligation at least 6 weeks prior to screening.
- •-Subject is of reproductive potential and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study and for 14 days after the last dose of study medication. Acceptable methods of birth control are: hormonal contraception, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
- •7. Subject understands the study procedures; alternative treatments available, risks involved with the study, and voluntarily agree to participate by giving written informed consent. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •8. Subject demonstrates compliance with eDiary use as shown by uploading fingerstick glucose values from the study supplied glucose meter daily.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •1. Subject has had one or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months.
- •2. Subject has a history of ketoacidosis in the last 6 months.
- •3. Subject, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L].
- •4. Subject has a history of intolerance or hypersensitivity to Lantus? or
- •contraindication to Lantus? or one of its excipients based on the label of the country of the investigational site.
- •5. Subject has used a formulation of insulin glargine other than Lantus?.
- •6. Subject received injectable incretin-based therapy (e.g., Victoza?, Byetta?) within the prior 8 weeks.
- •7. Subject is on a weight loss program and not in the maintenance phase, or has started a weight loss medication (such as orlistat) within the prior 8 weeks.
- •8. Subject has undergone bariatric surgery within 12 months prior to signing the informed consent.
- •9. Subject is currently participating in, or has participated in a study with an investigational compound or device within the prior 12 weeks of signing informed consent or is not willing to refrain from participating in another study.
- •10. Subject is likely to require treatment for ?2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids.
- •11. Subject has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study.
- •12. Subject has new or worsening signs or symptoms of coronary heart disease or congestive heart failure (NYHA Class II - IV cardiac status)
- •within the past 3 months, or has any of the following disorders within the past 3 months: Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention (e.g., CABG or PTCA), Stroke or transient ischemic neurological disorder.
- •13. Subject has severe peripheral vascular disease (e.g., claudication with minimal activity, a non-healing ischemic ulcer, or disease which is likely to require surgery or angioplasty).
- •14. Subject has a systolic blood pressure ?160 mm Hg or a diastolic ?95 mm Hg and blood pressure is not considered likely to be under these limits at Visit 2/Day 1 with an adjustment in antihypertensive medication.
- •15. Subject has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis).
- •16. Subject has active nephropathy (i.e., nephrotic syndrome or glomerulonephritis).
- •17. Subject has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease.
- •18. Subject has human immunodeficiency virus (HIV) as assessed by medical history.
- •19. Subject has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
- •20. Subject has a history of malignancy ?5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- •21. Subject has a history of melanoma, leukemia, lymphoma, or renal cell carcinoma.
- •22. Subject is currently being treated for hyperthyroidism.
- •23. Subject has been on stable dose of thyroid hormone replacement therapy for <6 weeks.
- •24. Subject is, at the time of signing informed consent, a user of recreational or illicit drugs
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