Title
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
Phase
Phase 2Lead Sponsor
Neurim Pharmaceuticals Ltd.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Diabetes Mellitus, Type 2 InsomniaIntervention/Treatment
melatonin ...Study Participants
36Objective - 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.
2 mg prolonged-release melatonin
Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
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).
| Event Type | Organ System | Event Term |
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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
