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

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ClinicalTrials.gov Identifier: NCT00869128
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : March 25, 2009
Last Update Posted : May 1, 2009
Sponsor:
Information provided by:
Neurim Pharmaceuticals Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Insomnia Drug: Circadin Drug: Placebo Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : November 1995
Actual Primary Completion Date : March 1997
Actual Study Completion Date : March 1997

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Arm Intervention/treatment
Placebo First
Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
Drug: Circadin
2 mg prolonged-release melatonin
Other Name: Prolonged-release melatonin (2mg)
Drug: Placebo
Circadin first
Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.
Drug: Circadin
2 mg prolonged-release melatonin
Other Name: Prolonged-release melatonin (2mg)
Drug: Placebo



Primary Outcome Measures :
  1. Sleep Efficiency [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869128


Sponsors and Collaborators
Neurim Pharmaceuticals Ltd.
Investigators
Principal Investigator: Doron Garfinkel, MD Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel

Responsible Party: Dr. Doron Garfinkel, Shoham Geriatric Medical Center,Pardes Hana 37000, Israel
ClinicalTrials.gov Identifier: NCT00869128     History of Changes
Other Study ID Numbers: Neu951005
First Posted: March 25, 2009    Key Record Dates
Results First Posted: March 25, 2009
Last Update Posted: May 1, 2009
Last Verified: March 2009

Keywords provided by Neurim Pharmaceuticals Ltd.:
melatonin
insomnia
diabetes
sleep

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Initiation and Maintenance Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants