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

December 8, 2008
March 30, 2009
November 1995
March 1997   (final data collection date for primary outcome measure)
Sleep Efficiency [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00869128 on ClinicalTrials.gov Archive Site
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A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Insomnia
  • Drug: Circadin
    2 mg prolonged-release melatonin
    Other Name: Prolonged-release melatonin (2mg)
  • Drug: Placebo
  • Placebo First
    Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
    Interventions:
    • Drug: Circadin
    • Drug: Placebo
  • Circadin first
    Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.
    Interventions:
    • Drug: Circadin
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 1997
March 1997   (final data collection date for primary outcome measure)

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).
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00869128
Neu951005
No
Dr. Doron Garfinkel, Shoham Geriatric Medical Center,Pardes Hana 37000, Israel
Neurim Pharmaceuticals Ltd.
Not Provided
Principal Investigator: Doron Garfinkel, MD Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel
Neurim Pharmaceuticals Ltd.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP