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

This study has been completed.
Sponsor:
Information provided by:
Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT00869128
First received: December 8, 2008
Last updated: March 30, 2009
Last verified: March 2009
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 8, 2008
Results First Received: December 8, 2008
Last Updated: March 30, 2009
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014