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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SBI Pharmaceuticals Co, Ltd.
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

1. Males and females residing in Bahrain aged 20 to 75 years old

2. Otherwise in good health in the opinion of the investigator based on results of medical history, physical exam and laboratory assessments

3. 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

4. BMI ≤44 kg/m2

5. Sitting BP ≤ 160/100mm Hg

6. Sleep apnea screening is negative

7. Ophthalmological exam is within normal limits as judged by the investigator. If findings are observed, they must be judged as not clinically significant.

8. 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:

1. Liver dysfunction defined as liver function tests >1.5 times upper limit of normal

2. 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

3. History of any life-threatening disease, cardiovascular disease, viral hepatitis, porphyria or hemochromatosis

4. Allergy to ALA, SFC, or any other component of study product

5. Use of insulin for management of serum glucose

6. Hypoglycemic event within the previous 3 months, defined as serum glucose levels less than 70 mg/dL

7. History of sickle cell anemia disease