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

NCT02481141 | Completed Results

• 1 other identifier: SBIP12-002F
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change From Baseline in 2 Hour Post Meal Glucose Level

  Baseline, Week 2, Week 4, Week 12

• Change From Baseline in Body Weight

  Baseline, Week 6, Week 12

• Change From Baseline in HbA1c

  Baseline, Week 2, Week 4, Week 12

• Change From Baseline in Total Cholesterol (Component of Lipid Profile)

  Baseline, Week 6, Week 12

• Change From Baseline LDL (Component of Lipid Profile)

  Baseline, Week 6, Week 12

Study Arms (2)

5-ALA-SFC

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

5-ALA-SFC DRUG

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

5-ALA-SFC

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females residing in Bahrain aged 20 to 75 years old
• Otherwise in good health in the opinion of the investigator based on results of medical history, physical exam and laboratory assessments
• 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
• BMI ≤44 kg/m2
• Sitting BP ≤ 160/100mm Hg
• Sleep apnea screening is negative
• Ophthalmological exam is within normal limits as judged by the investigator. If findings are observed, they must be judged as not clinically significant.
• Female subjects are not pregnant, not breast-feeding, and if of childbearing potential, have agreed to use an acceptable method of birth control

You may not qualify if:

• Liver dysfunction defined as liver function tests \>1.5 times upper limit of normal
• 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
• History of any life-threatening disease, cardiovascular disease, viral hepatitis, porphyria or hemochromatosis
• Allergy to ALA, SFC, or any other component of study product
• Use of insulin for management of serum glucose
• Hypoglycemic event within the previous 3 months, defined as serum glucose levels less than 70 mg/dL
• History of sickle cell anemia disease

Sponsors & Collaborators

• SBI Pharmaceuticals Co, Ltd.: lead

Related Publications (1)

• 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.

  PMID: 27738640 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Riyadh Rehani, President of MENA Region
• Organization: SBI Pharmaceuticals Co, Ltd.

rrehani@sbigroup.co.jp

+973 66394100

Study Officials

• Riyadh Rehani, Ph.D.

  SBI Pharmaceuticals Co, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 25, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 22, 2018
• Results First Posted: December 11, 2017

Record last verified: 2018-04