Status:
COMPLETED
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
Lead Sponsor:
Neurim Pharmaceuticals Ltd.
Conditions:
Diabetes Mellitus, Type 2
Insomnia
Eligibility:
All Genders
Phase:
PHASE2
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 me...
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 b...
Eligibility Criteria
Inclusion
- Diabetic patients with proven presence of the disease who complained of insomnia.
Exclusion
- Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).
Key Trial Info
Start Date :
November 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1997
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00869128
Start Date
November 1 1995
End Date
March 1 1997
Last Update
May 1 2009
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