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

NCT ID: NCT00869128

Last Updated: 2009-05-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-11-30

Study Completion Date

1997-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo First

Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).

Group Type OTHER

Circadin

Intervention Type DRUG

2 mg prolonged-release melatonin

Placebo

Intervention Type DRUG

Circadin first

Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.

Group Type OTHER

Circadin

Intervention Type DRUG

2 mg prolonged-release melatonin

Placebo

Intervention Type DRUG

Interventions

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Circadin

2 mg prolonged-release melatonin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Prolonged-release melatonin (2mg)

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurim Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Shoham Geriatric Medical Center,Pardes Hana 37000, Israel

Principal Investigators

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Doron Garfinkel, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel

Other Identifiers

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Neu951005

Identifier Type: -

Identifier Source: org_study_id

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