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

Primary Purpose

Diabetes Mellitus, Type 2, Insomnia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Circadin
Placebo
Sponsored by
Neurim Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring melatonin, insomnia, diabetes, sleep

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Placebo First

    Circadin first

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Sleep Efficiency
    Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period

    Secondary Outcome Measures

    Full Information

    First Posted
    December 8, 2008
    Last Updated
    March 30, 2009
    Sponsor
    Neurim Pharmaceuticals Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00869128
    Brief Title
    A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1995 (undefined)
    Primary Completion Date
    March 1997 (Actual)
    Study Completion Date
    March 1997 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Neurim Pharmaceuticals Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Insomnia
    Keywords
    melatonin, insomnia, diabetes, sleep

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo First
    Arm Type
    Other
    Arm Description
    Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
    Arm Title
    Circadin first
    Arm Type
    Other
    Arm Description
    Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    Circadin
    Other Intervention Name(s)
    Prolonged-release melatonin (2mg)
    Intervention Description
    2 mg prolonged-release melatonin
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Sleep Efficiency
    Description
    Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Doron Garfinkel, MD
    Organizational Affiliation
    Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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