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NCT00869128 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00869128
Other study ID # Neu951005
Secondary ID
Status Completed
Phase Phase 2
First received December 8, 2008
Last updated March 30, 2009
Start date November 1995
Est. completion date March 1997

Study information
Verified date March 2009
Source Neurim Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date March 1997
Est. primary completion date March 1997
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Circadin
2 mg prolonged-release melatonin
• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Neurim Pharmaceuticals Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep Efficiency 3 weeks No
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