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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: 5-ALA-SFC

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 5-ALA-SFC; Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA - SFC
Placebo Comparator: 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	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SBI Pharmaceuticals Co, Ltd.
• Investigators: Study Director: Riyadh Rehani, Ph.D., SBI Pharmaceuticals Co, Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SBIP12-002F