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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869128
First Posted: March 25, 2009
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Neurim Pharmaceuticals Ltd.
  Purpose
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 Intervention Phase
Diabetes Mellitus, Type 2 Insomnia Drug: Circadin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Neurim Pharmaceuticals Ltd.:

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

Enrollment: 36
Study Start Date: November 1995
Study Completion Date: March 1997
Primary Completion Date: March 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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).
  Contacts and Locations
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
  More Information

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 Submitted: December 8, 2008
First Posted: March 25, 2009
Results First Submitted: December 8, 2008
Results First Posted: March 25, 2009
Last Update Posted: July 29, 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