CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Circadin +1 moredrug
Likely dose
Circadin 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00869128
NCT00869128Phase 2Completed
CompareCT.gov

A Randomized Double-Blind, Crossover Study Comparing the Efficacy of Prolonged-Release Melatonin Versus Placebo in a 3 Week Treatment of Diabetic Patients Suffering From Insomnia

Neurim Pharmaceuticals Ltd.·interventional·Posted Mar 25, 2009·Updated May 1, 2009

In Brief

A Phase 2 clinical trial evaluating Circadin and Placebo for Diabetes Mellitus, Type 2 and Insomnia. Completed, enrolled 36 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Insomnia
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 25, 2009
Enrollment StartNov 1, 1995
Primary CompletionMar 1, 1997
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.3 years ago

Interventions

Circadindrug

2 mg prolonged-release melatonin

Placebodrug