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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: 5-ALA-SFC; Drug: Placebo

• Registration Number: NCT02481141
• Lead Sponsor: SBI Pharmaceuticals Co, Ltd.

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-11-03
• Results First Submitted QC: 2017-11-07
• Results First Posted: 2017-12-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-ALA-SFC	5-ALA-SFC	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
Placebo	Placebo	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

Primary Outcome Measures

Name	Time	Method
Subjects With Adverse Events as a Measure of Safety and Tolerability	Week 2, Week 4, Week 12	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.
Change From Baseline in Fasting Blood Glucose	Baseline, Week 2, Week 4, Week 12	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.

Secondary Outcome Measures

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