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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Insomnia Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks with 1 tablet per night of 2 mg prolonged-release melatonin or placebo, with one week washout period in between. Sleep was objectively monitored by wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, cholesterol (total, HDL and LDL) and some antioxidants were assessed at baseline and end of each period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Circadin

Drug

2 mg prolonged-release melatonin

Other names: Prolonged-release melatonin (2mg)

Placebo

Drug

Primary outcomes

Sleep Efficiency

Time frame: 3 weeks

Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period

Sponsors and collaborators

Lead sponsor

Neurim Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 1995
Primary completion: 1997
Study completion: 1997
First posted: Mar 25, 2009
Registry last updated: May 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed