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

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.

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