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
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus-type-2
Started Nov 1995
Typical duration for phase_2 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1995
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 1997
CompletedFirst Submitted
Initial submission to the registry
December 8, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedResults Posted
Study results publicly available
March 25, 2009
CompletedMay 1, 2009
March 1, 2009
1.3 years
December 8, 2008
December 8, 2008
March 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 weeks
Study Arms (2)
Placebo First
OTHERSubjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
Circadin first
OTHERSubjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Diabetic patients with proven presence of the disease who complained of insomnia.
You may not qualify if:
- Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- D. Garfinkel , MD
- Organization
- Shoham Geriatric Medical Center, Pardes Hana, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Doron Garfinkel, MD
Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 8, 2008
First Posted
March 25, 2009
Study Start
November 1, 1995
Primary Completion
March 1, 1997
Study Completion
March 1, 1997
Last Updated
May 1, 2009
Results First Posted
March 25, 2009
Record last verified: 2009-03