EUCTR2013-002172-40-RO进行中（未招募）1 期
A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 426115 (an Antisense Glucocorticoid Receptor Antagonist) Administered Subcutaneously Once Weekly for 6 Weeks to Patients with Type 2 Diabetes Mellitus Being Treated with Metformin - ISIS 426115-CS2
Isis Pharmaceuticals, Inc.0 个研究点目标入组 40 人开始时间: 2019年7月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
入选标准
- •1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
- •2. Males or females. Aged 18 to 75 years at the time of informed consent
- •3. Females must be non-pregnant and non-lactating and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal (12 months of natural [spontaneous] amenorrhea together with FSH confirmation of postmenopausal state). Males must be surgically sterile, abstinent or if engaged in sexual relations with women of child-bearing potential, the patient must be using an acceptable contraceptive method during dosing and for 12 weeks after the last dose of Study Drug
- •4. BMI =25 kg/m2
- •5. Clinically confirmed diagnosis of T2DM
- •6. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to Screening and will be required to continue the stable dose of metformin throughout the study
- •7. HbA1c =7.5% and =10.5% at Screening
- •8. Agree to maintain current diet and exercise regimen throughout the study
- •9. Agree to conduct daily morning (fasted) blood glucose testing using the study glucometer throughout the study
- •10. Agree to abstain from alcoholic beverages 48 hours prior to Study Center visits
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Clinically significant abnormalities in medical history
- •2. Screening laboratory results as follows
- •Urine protein/creatinine (P/C) ratio >0.2 mg/mg. In the event of P/C ratio above this threshold eligibility may be confirmed by a quantitative total urine protein measurement of <300 mg/24 hour
- •Positive test (including trace) for blood on urinalysis. In the event of a positive test, eligibility may be confirmed with urine microscopy showing <5 red blood cells per high power field
- •Serum creatinine >ULN
- •Estimated GFR <60 mL/min (as determined by the Cockcroft-Gault Equation for Creatinine Clearance)
- •History of or clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST >1.5 x ULN; or total bilirubin >ULN at Screening
- •Have a current or previous diagnosis of Gilbert’s disease
- •Platelet count <140,000/mm3 at Screening
- •3. Show evidence of uncorrected hypothyroidism or hyperthyroidism at Screening. Patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to Screening will be allowed to participate as long as thyroid tests (TSH/T3/T4) show that patient is euthyroid
- •4. History of renal transplantation or renal dialysis
- •5. Clinically significant complications of diabetes (e.g., history of painful neuropathy, nephropathy, proliferative retinopathy and/or foot ulcers)
- •6. Within 6 months prior to Screening have any of the following:
- •More than 3 episodes of severe hypoglycemia requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions;
- •One (1) event of hypoglycemia in which the patient required hospitalization;
- •A current diagnosis of hypoglycemia unawareness
- •7. Treatment with antidiabetic drugs other than metformin including insulin, thiazolidinedione, a-glucosidase inhibitor, GLP-1 agonist or DPP-IV inhibitor and other drugs that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months prior to Screening
- •8. Confirmed reduction in fasting plasma glucose (FPG) of >40 mg/dL (>2.2 mmol/L) at the Pre-treatment Visit (Week-1, Day-7) compared to a FPG value taken during the Screening Period; or fasted self-monitored plasma glucose (SMPG) values <140 mg/dL for >75% of measurements collected during Week -3 through Week -2
- •9. History of diabetic ketoacidosis
- •10. Treatment with lipid lowering therapy with the exception of statins. Statins are allowed at stable doses (=3 months) prior to Screening and within the dose levels listed below. Other statin regimens should be discussed with the Sponsor Medical Monitor or designee
- •Simvastatin at =40 mg/day
- •Atorvastatin, fluvastatin, or lovastatin at =20 mg/day
- •Rosuvastatin or pravastatin at =10 mg/day
- •Pitavastatin at =2 mg/day
- •11. Treatment with non-selective beta-blockers such as propranolol within 3 months of Screening and
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