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

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ClinicalTrials.gov Identifier: NCT02481141
Recruitment Status : Completed
First Posted : June 25, 2015
Results First Posted : December 11, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
SBI Pharmaceuticals Co, Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: 5-ALA-SFC Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Subjects With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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.

  2. Change From Baseline in Fasting Blood Glucose [ Time Frame: 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 :
  1. Change From Baseline in 2 Hour Post Meal Glucose Level [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]
    Change from baseline in blood glucose levels 2 hours after breakfast

  2. Change From Baseline in Body Weight [ Time Frame: Baseline, Week 6, Week 12 ]
    Change from baseline measured at week 6 and week 12 only

  3. Change From Baseline in HbA1c [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]
    Change from baseline in HbA1c %

  4. Change From Baseline in Total Cholesterol (Component of Lipid Profile) [ Time Frame: Baseline, Week 6, Week 12 ]
    Change from baseline measured at week 6 and week 12 only

  5. Change From Baseline LDL (Component of Lipid Profile) [ Time Frame: Baseline, Week 6, Week 12 ]
    Change from baseline measured at week 6 and week 12 only

  6. Change From Baseline in HDL (Component of Lipid Profile) [ Time Frame: Baseline, Week 6, Week 12 ]
    Change from baseline measured at week 6 and week 12 only

  7. Change From Baseline in Triglycerides (Component of Lipid Profile) [ Time Frame: Baseline, Week 6, Week 12 ]
    Change from baseline measured at week 6 and week 12 only


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481141


Sponsors and Collaborators
SBI Pharmaceuticals Co, Ltd.
Investigators
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Study Director: Riyadh Rehani, Ph.D. SBI Pharmaceuticals Co, Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: SBI Pharmaceuticals Co, Ltd.
ClinicalTrials.gov Identifier: NCT02481141    
Other Study ID Numbers: SBIP12-002F
First Posted: June 25, 2015    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: May 22, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases