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

SBI Pharmaceuticals

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: 5-ALA-SFC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02481141

SBIP12-002F

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 53 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups, including a placebo group

5-ALA-SFC

Active Comparator group

Description:

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

Treatment:

Drug: 5-ALA-SFC

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo