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

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.

Timeline

Start

1995-11

Primary completion

1997-03

Completion

1997-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Circadin; p = 0.04; ANOVA NCT00869128 ↗

Drugs

Indications