drugset / Trial / NCT00869128

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

NCT00869128

Phase 2 Completed 36 enrolled Neurim Pharmaceuticals Ltd.
RandomizedCrossoverDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 2 mg