NCT01591902终止4 期
A Prospective, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate Whether EGRIFTA® (Tesamorelin for Injection), 2 mg Once Daily SC, Increases the Risk of Development or Progression of Diabetic Retinopathy When Administered to HIV-infected Subjects With Abdominal Lipohypertrophy and Concomitant Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 129
- 试验地点
- 24
- 主要终点
- Difference in percentages of subjects with a 3-step or greater progression (from both eyes) on the Early Treatment Diabetic Retinopathy Study (ETDRS) PERSON scale.
研究概览
简要总结
To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
详细描述
To date, EGRIFTA® has not been studied for longer than 1 year in human subjects, nor has EGRIFTA® been studied in Type 2 diabetic HIV-infected subjects who are receiving oral hypoglycemic agents, GLP-1 analogues, or insulin. The present study will assess the potential of EGRIFTA® to induce or exacerbate DR in HIV-infected subjects on antiretroviral therapy who have concomitant abdominal lipohypertrophy and T2DM, and explore the long-term effects of EGRIFTA® on glycemic control and major adverse cardiovascular event (MACE) in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subject has Type 1 DM;
- •Subject has body mass index (BMI) < 18.5 kg.m2;
- •Subject has or has had an opportunistic infection or acquired immune deficiency syndrome (AIDS)-defining illness within 3 months of screening;
- •Subject has or has had a malignancy or, for women, personal or family (first degree relative) history of breast cancer. Exceptions are basal cell carcinoma, in situ carcinoma of the cervix, in situ anal carcinoma, treated and stable cutaneous squamous cell carcinoma. and stable Kaposi's sarcoma;
- •Pre-existing PDR or severe non-PDR (NPDR), defined as an ETDRS level of ≥ 53 in either eye;
- •Subject has or has had cytomegalovirus (CMV) retinitis, toxoplasmosis, or any other ocular infection that would prevent evaluation of DR;
- •Subject has previously been treated for DR (treatments such as laser photocoagulation, intravitreal injection, or vitrectomy);
- •Subject has any of the following illnesses or conditions:
- •hypopituitarism, history of pituitary tumor or pituitary surgery;
- •untreated hypothyroidism;
- •head irradiation or head trauma that has affected the somatotropic axis;
- •uncontrolled hypertension, defined as systolic pressure > 140 mm Hg and diastolic pressure > 90 mm Hg;
- •unstable CV condition, defined as:
- •i. acute MI; ii. unstable angina; iii. decompensated congestive heart failure (CHF, new onset or exacerbation); iv. stroke; v. history of any of the above within 6 months prior to screening; f. hepatic abnormality, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (3 x ULN); g. renal abnormality, defined as serum creatinine > 2 x ULN; h. lipid metabolism abnormality, defined as fasting triglycerides > 1500 mg/dL; i. anemia, defined as hemoglobin ≤ 7 g/dL;
- •Drug or hormone use as follows
- •Men: change in regimen or supraphysiological dose of testosterone within 2 months prior to screening;
- •anabolic steroids, GH, GH secretagogue, GHRF products or analogs (including EGRIFTA®), IGF-1, or IGF binding protein 3 (IGFBP 3) within 6 months prior to screening;
- •Drug or alcohol dependence within 6 months prior to screening;
- •Subject is using or has used anorectics, anorexigenics, or anti-obesity agents within 3 months prior to screening;
- •Subject is pregnant or nursing;
- •Other significant disease that, in the Investigator's opinion, would exclude the subject from the trial;
- •Participation, within 30 days prior to screening, in another clinical trial of an investigational agent that could affect IGF-1 levels;
- •Known hypersensitivity to the study drug treatments.
研究组 & 干预措施
EGRIFTA Treatment Grop
Experimental
Sterile, lyophilized, nonpyrogenic powder containing tesamorelin acetate with mannitol as excipient
干预措施: Tesamorelin (Drug)
Placebo
Placebo Comparator
Placebo-controlled
干预措施: Placebo-Control (Drug)
结局指标
主要结局
Difference in percentages of subjects with a 3-step or greater progression (from both eyes) on the Early Treatment Diabetic Retinopathy Study (ETDRS) PERSON scale.
时间窗: 3 years
Subjects will undergo an opthamologic examination including fundus photographs at 3 month intervals for duration of 36 months
次要结局
- Change from baseline in HbA1c by intensification of concomitant diabetic treatment(3 years)
研究者
研究点 (24)
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