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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2; Insomnia
• Interventions: Drug: Circadin; Drug: Placebo

• Registration Number: NCT00869128
• Lead Sponsor: Neurim Pharmaceuticals Ltd.

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.

Study Timeline

• Study Start: 1995-11
• Primary Completion: 1997-03
• Study Completion: 1997-03
• Study First Submitted: 2008-12-08
• Results First Submitted: 2008-12-08
• Status Verified: 2009-03
• Study First Submitted QC: 2009-03-24
• Results First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Results First Posted: 2009-03-25
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo First	Circadin	Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
Placebo First	Placebo	Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
Circadin first	Circadin	Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.
Circadin first	Placebo	Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency	3 weeks	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