Clinical trial NCT02481141: Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: SBI Pharmaceuticals Co, Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-25
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Subjects With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Week 2, Week 4, Week 12
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline, Week 2, Week 4, Week 12
Secondary outcomes:
measure: Change From Baseline in 2 Hour Post Meal Glucose Level
timeFrame: Baseline, Week 2, Week 4, Week 12
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 6, Week 12
measure: Change From Baseline in HbA1c
timeFrame: Baseline, Week 2, Week 4, Week 12
measure: Change From Baseline in Total Cholesterol (Component of Lipid Profile)
timeFrame: Baseline, Week 6, Week 12
measure: Change From Baseline LDL (Component of Lipid Profile)
timeFrame: Baseline, Week 6, Week 12
measure: Change From Baseline in HDL (Component of Lipid Profile)
timeFrame: Baseline, Week 6, Week 12
measure: Change From Baseline in Triglycerides (Component of Lipid Profile)
timeFrame: Baseline, Week 6, Week 12
Other outcomes:
Locations:
Study officials:
affiliation: SBI Pharmaceuticals Co, Ltd.
name: Riyadh Rehani, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Al-Saber F, Aldosari W, Alselaiti M, Khalfan H, Kaladari A, Khan G, Harb G, Rehani R, Kudo S, Koda A, Tanaka T, Nakajima M, Darwish A. The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain. J Diabetes Res. 2016;2016:8294805. doi: 10.1155/2016/8294805. Epub 2016 Sep 22.