Condition category
Nervous System Diseases
Date applied
25/02/2009
Date assigned
27/02/2009
Last edited
27/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Moshe Laudon

ORCID ID

Contact details

Neurim Pharmaceuticals Ltd.
27 Habarzel St.
Tel Aviv
69710
Israel

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Neu951005

Study information

Scientific title

A randomised double-blind, crossover study comparing the efficacy of prolonged-release melatonin versus placebo in a three-week treatment of diabetic patients suffering from insomnia

Acronym

Study hypothesis

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.

Ethics approval

Ethics Committee of the E. Wolfson Medical Centre Holon, approved on 01/11/1995 (ref: 5471)

Study design

Randomised double-blind placebo-controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Type 2 diabetes mellitus, insomnia

Intervention

In a randomised, double-blind, crossover study, the subjects were treated for 3 weeks with 1 tablet per night of 2 mg prolonged-release melatonin (Circadin®) (oral) or placebo, with one week washout period in between.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Sleep efficiency (Time Frame: 3 weeks). Efficacy of sleep quality was objectively monitored by a wrist actigraphy device (Somnitor™). Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm.

Secondary outcome measures

Safety. Total duration of follow-up: 3 weeks

Overall trial start date

01/11/1995

Overall trial end date

01/03/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Independently living male and female patients (no age limits) who complained of insomnia and suffer from diabetes.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36

Participant exclusion criteria

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

Recruitment start date

01/11/1995

Recruitment end date

01/03/1997

Locations

Countries of recruitment

Israel

Trial participating centre

Neurim Pharmaceuticals Ltd.
Tel Aviv
69710
Israel

Sponsor information

Organisation

Neurim Pharmaceuticals Ltd. (Israel)

Sponsor details

27 Habarzel St.
Tel Aviv
69710
Israel
info@neurim.com

Sponsor type

Industry

Website

http://www.neurim.com

Funders

Funder type

Industry

Funder name

Neurim Pharmaceuticals Ltd. (Isreal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes