An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Insulin Resistance and Glucose Homeostasis
研究概览
简要总结
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:
- The safety and tolerability of multiple doses of INT 747;
- The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;
- Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;
- Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.
详细描述
This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes, defined by the American Diabetes Association (ADA), as one of the following criteria:
- •Symptoms of diabetes plus casual plasma glucose concentration >200 mg/dL (11.1 mmol/L) or
- •Fasting plasma glucose >126 mg/dL (7.0 mmol/L) or
- •2-hour post-load glucose >200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance test (GTT).
- •Presumed NAFLD, defined by one of the following criteria:
- •Alanine aminotransferase (ALT) ≥47 U/L for females and ≥56 U/L for males
- •Aspartate aminotransferase (AST) ≥47 U/L for females and ≥60 U/L for males
- •Enlarged liver (demonstrated by ultrasound or other imaging technique)
- •Diagnostic histological findings shown on prior biopsy (in the last 5 years).
排除标准
- •Bilirubin >2 × ULN
- •ALT >155 U/L for females and >185 U/L for males.
- •AST >155 U/L for females and >200 U/L for males.
- •Patients taking any antidiabetic medications, with the exception of metformin and sulfonylureas. If the HbA1c is <11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.
研究组 & 干预措施
25 mg INT-747
干预措施: INT-747 (Drug)
50 mg INT-747
干预措施: INT-747 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Insulin Resistance and Glucose Homeostasis
时间窗: baseline and 6 weeks
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).
次要结局
- Hepatocellular Function(baseline and 6 weeks)