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

Neurim Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Insomnia; Diabetes Mellitus, Type 2

Treatments: Drug: Circadin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00869128

Neu951005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Placebo First

Other group

Description:

Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).

Treatment:

Drug: Placebo

Drug: Circadin

Circadin first

Other group

Description:

Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.

Treatment:

Drug: Placebo

Drug: Circadin