MRI has sponsored clinical trials in humans evaluating the safety of Glucotize, receiving very favorable results (see below).

Clinical Safety and Efficacy

An IRB-approved human study on the effect of Glucotize on Type 2 diabetics has been completed. The results are published in Endocrine Practice Vol. 8, No. 1 January/February. Patients received 12 weeks of active treatment, 900 mg/day for 6 weeks and 1200 mg/day for 6 weeks. Subjects remained on existing anti-hyperglycemic medications. They were monitored on a regular basis for glucose and lipid control, liver enzymes, and other clinical markers. The results are as follows:

Safety Data

• No significant side effects
• No changes in liver enzyme or liver function
• No changes in kidney function
  

Efficacy Data

• Clinically-significant reduction on plasma fructosamine
• Reduction of glycated hemoglobin (HbA1c) in about 50% of the patient

Toxicity

The results of clinical study, using 1800 mg/day of alpha-lipoic acid, are published in Free Radic Biol Med 27:309-314, 1999 show that, at the recommended doses, alpha-lipoic acid is very well tolerated in humans.

Interactions

There are no known drug interactions with alpha-lipoic acid or Glucotize (controlled-release alpha-lipoic acid).

Overdoses

There are no reports of alpha-lipoic acid overdosage.