N/A
Completed N=53
Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes
Source: ClinicalTrials.gov NCT02481141 ↗Enrolled (actual)
53
Serious AEs
0.6%
Results posted
Dec 2017
Primary outcomePrimary: Subjects With Adverse Events as a Measure of Safety and Tolerability — 6; 8; 2; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Adverse Events as a Measure of Safety and Tolerability |
6; 8; 2; 3; 1; 1 | — |
| PRIMARY Change From Baseline in Fasting Blood Glucose |
2.3; -0.2; -3.0; -7.3; -0.8; -4.2 | — |
| SECONDARY Change From Baseline in 2 Hour Post Meal Glucose Level |
-0.2; -12.9; -8.5; -26.5; -18.8; -33.0 | — |
| SECONDARY Change From Baseline in Body Weight |
-0.1; -0.2; -0.3; -0.8 | — |
| SECONDARY Change From Baseline in HbA1c |
-0.2; -0.3; -0.7; -0.5; -0.5; -0.5 | — |
| SECONDARY Change From Baseline in Total Cholesterol (Component of Lipid Profile) |
-5.2; 6.8; -7.6; -0.1 | — |
| SECONDARY Change From Baseline LDL (Component of Lipid Profile) |
-2.9; 7.6; -11.8; -4.0 | — |
| SECONDARY Change From Baseline in HDL (Component of Lipid Profile) |
-0.8; 0.5; -1.6; -1.1 | — |
| SECONDARY Change From Baseline in Triglycerides (Component of Lipid Profile) |
-1.3; 3.2; 4.5; 11.9 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT02481141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.