Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: 5-ALA-SFC
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5-ALA-SFC<br>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 | Drug: 5-ALA-SFC<br>* Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA - SFC<br>|
| Placebo Comparator: Placebo<br>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 | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With Adverse Events as a Measure of Safety and Tolerability | 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. | Week 2, Week 4, Week 12 | 
| Change From Baseline in Fasting Blood Glucose | 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. | Baseline, Week 2, Week 4, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 2 Hour Post Meal Glucose Level | Change from baseline in blood glucose levels 2 hours after breakfast | Baseline, Week 2, Week 4, Week 12 | 
| Change From Baseline in Body Weight | Change from baseline measured at week 6 and week 12 only | Baseline, Week 6, Week 12 | 
| Change From Baseline in HbA1c | Change from baseline in HbA1c % | Baseline, Week 2, Week 4, Week 12 | 
| Change From Baseline in Total Cholesterol (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | Baseline, Week 6, Week 12 | 
| Change From Baseline LDL (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | Baseline, Week 6, Week 12 | 
| Change From Baseline in HDL (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | Baseline, Week 6, Week 12 | 
| Change From Baseline in Triglycerides (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | Baseline, Week 6, Week 12 |