A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia

• Status: Completed
• Trial end date: 1997-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurim Pharmaceuticals Ltd.
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Diabetic patients with proven presence of the disease who complained of insomnia.

Exclusion Criteria:

• Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).