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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481141
• Other study ID #: SBIP12-002F
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2018
• Source: SBI Pharmaceuticals Co, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SBI Pharmaceuticals Co, Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Change From Baseline in Body Weight	Change from baseline measured at week 6 and week 12 only	Baseline, Week 6, Week 12
Secondary	Change From Baseline in HbA1c	Change from baseline in HbA1c %	Baseline, Week 2, Week 4, Week 12
Secondary	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
Secondary	Change From Baseline LDL (Component of Lipid Profile)	Change from baseline measured at week 6 and week 12 only	Baseline, Week 6, Week 12
Secondary	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
Secondary	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