EUCTR2021-004226-30-HU进行中（未招募）1 期
A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Glucose-lowering Agents as Monotherapy.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Oramed Ltd.
- 入组人数
- 450
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. Male and female subjects aged, 18 to 75 years.
- •2. Established diagnosis of T2DM prior to Screening AND an A1C = 7.0% but = 9.0% at Screening.
- •3. Subjects should be on:
- •a. Diet and exercise therapy and have never been treated with any oral or injectable glucose-lowering therapy, determined at Screening; OR
- •b. Diet and exercise therapy with no oral or injectable glucose-lowering therapy for a period of at least 3 months prior to Screening; OR
- •c. Diet and exercise therapy with a stable glucose-lowering agent as monotherapyfor a period of at least 3 months prior to Screening.
- •4. Body mass index (BMI) of 25-40 kg/m2at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
- •5. Renal function – eGFR = 30 ml/min.
- •6. Females of childbearing potential must:
- •a. have a negative serum pregnancy test result at Screening.
- •b. agree to avoid becoming pregnant while receiving IP for at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP.
- •c. agree to use an acceptable method of contraception at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP. Acceptable methods of contraception are hormonal contraception (contraceptive pill or injection) PLUS an additional barrier method of contraception such as a diaphragm, condom, sponge, or spermicide.
- •d. In the absence of hormonal contraception, double-barrier methods must be used which include a combination of any two of the following: diaphragm, condom, copper intrauterine device, sponge, or spermicide, and must be used for at least 30 days prior to administration of IP, during the entire study, and for 30 days following their last dose of IP.
- •e. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and
- •ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.
- •f. Females who are not of childbearing potential are defined as:
- •i. Postmenopausal (defined as at least 12 months with no menses in women =45 years of age); OR
- •ii. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR
- •iii. Have a congenital or acquired condition that prevents childbearing.
- •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 383
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 67
排除标准
- •1. Type 1 diabetes.
- •2. A history of diabetes mellitus with ketoacidosis or is assessed by the Investigator as possibly having type 1 diabetes mellitus confirmed by a C-peptide < 0.4 ng/mL (0.13 nmol/L) at Screening.
- •3. Diabetes attributable to other secondary causes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
- •4. Concomitant treatment involving insulin, and any other inhaled, oral or injectable antihyperglycemic agents including alpha glucosidase inhibitor, meglitinides, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione or GLP-1 agonists, and pramlintide except for metformin within 2 months prior to Visit 1.
- •5. A history of >2 episodes of severe hypoglycemia within 6 months prior to Screening.
- •6. A history of hypoglycemic unawareness.
- •7. A history of unstable angina or myocardial infarction within 6 months prior to Screening, New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure (CHF), valvular heart disease, ventricular cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, coronary angioplasty, stroke or transient ischemic attack (TIA) within 6 months prior to Screening.
- •8. A history of uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg. A single repeat measurement will be permitted.
- •9. Renal dysfunction: eGFR < 30 mL/min.
- •10. A history of or active proliferative retinopathy requiring treatment.
- •11. Psychiatric disorders that, per Investigator judgment, may have impact on the safety of the subject or interfere with subject’s participation or compliance in the study.
- •12. Laboratory abnormalities at Screening including:
- •a. C-peptide < 0.4 ng/mL.
- •b. Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X the upper limit of normal; a single repeat test is allowable.
- •c. Elevated liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) >3X the upper limit of normal; a single repeat test is allowable.
- •d. Very elevated fasting triglyceride levels (>600 mg/dL); a single repeat test is allowable.
- •e. Any relevant abnormality that would interfere with the efficacy or the safety assessments during study treatment administration.
- •13. Positive history of active liver disease (other than non- alcoholic hepatic steatosis), primary biliary cirrhosis, or active symptomatic gallbladder disease.
- •14. Positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus ribonucleic acid (RNA).
- •15. Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma or carcinoma in situ of the cervix) within the past 5 years prior to baseline.
- •16. Use of the following medications:
- •a. History of use of any injectable or inhaled, basal, pre- mixed or prandial insulin (greater than 7 days) within 6 months prior to Screening.
- •b. Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within 6 weeks prior to Screening.
- •c. Requirements (in the last 12 months), or may require, systemic (oral, intravenous, intramuscular) glucocorticoid therapy for more than 2 weeks during the study period. I
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