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

NCT02481141 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-05-22

Study results available
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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

Interventions

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

DRUG

Placebo

Sponsors & Collaborators

  • SBI Pharmaceuticals Co, Ltd.

    lead INDUSTRY

Principal Investigators

  • Riyadh Rehani, Ph.D. · SBI Pharmaceuticals Co, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481141 on ClinicalTrials.gov