Prospective, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Subjects With Type II Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Subjects With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes.
详细描述
The primary objective is to assess the safety of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes mellitus. Safety will be assessed by the incidence of adverse events and clinically significant laboratory results.
The secondary objective is to assess the efficacy of 5-ALA-SFC at doses up to 200 mg per day on glycemic control in subjects with type II diabetes mellitus. Efficacy measures will include fasting plasma glucose level, HbA1c level, lipid profile, and body weight.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females residing in Bahrain aged 20 to 75 years old
- •Otherwise in good health in the opinion of the investigator based on results of medical history, physical exam and laboratory assessments
- •Diagnosed with type II diabetes mellitus with HbA1c >6.5 and <10% which is uncontrolled despite the use of one or more glycemia-lowering drugs
- •BMI ≤44 kg/m2
- •Sitting BP ≤ 160/100mm Hg
- •Sleep apnea screening is negative
- •Ophthalmological exam is within normal limits as judged by the investigator. If findings are observed, they must be judged as not clinically significant.
- •Female subjects are not pregnant, not breast-feeding, and if of childbearing potential, have agreed to use an acceptable method of birth control
排除标准
- •Liver dysfunction defined as liver function tests >1.5 times upper limit of normal
- •Renal dysfunction defined as BUN and/or serum creatinine >1.5 times upper limit of normal and/or eGFR <30 ml/min/1.73 m2
- •History of any life-threatening disease, cardiovascular disease, viral hepatitis, porphyria or hemochromatosis
- •Allergy to ALA, SFC, or any other component of study product
- •Use of insulin for management of serum glucose
- •Hypoglycemic event within the previous 3 months, defined as serum glucose levels less than 70 mg/dL
- •History of sickle cell anemia disease
研究组 & 干预措施
5-ALA-SFC
Study product administration will be as follows:
Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks
干预措施: 5-ALA-SFC (Drug)
Placebo
Study matching placebo administration will be as follows:
Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Subjects With Adverse Events as a Measure of Safety and Tolerability
时间窗: Week 2, Week 4, Week 12
The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA - SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.
Change From Baseline in Fasting Blood Glucose
时间窗: Baseline, Week 2, Week 4, Week 12
The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA - SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.
次要结局
- Change From Baseline in 2 Hour Post Meal Glucose Level(Baseline, Week 2, Week 4, Week 12)
- Change From Baseline in Body Weight(Baseline, Week 6, Week 12)
- Change From Baseline in HbA1c(Baseline, Week 2, Week 4, Week 12)
- Change From Baseline in Total Cholesterol (Component of Lipid Profile)(Baseline, Week 6, Week 12)
- Change From Baseline LDL (Component of Lipid Profile)(Baseline, Week 6, Week 12)
- Change From Baseline in HDL (Component of Lipid Profile)(Baseline, Week 6, Week 12)
- Change From Baseline in Triglycerides (Component of Lipid Profile)(Baseline, Week 6, Week 12)