Efficacy of prolonged-release melatonin versus placebo in a three-week treatment of diabetic patients suffering from insomnia

A randomised double-blind, crossover study comparing the efficacy of prolonged-release melatonin versus placebo in a three-week treatment of diabetic patients suffering from insomnia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55944464

Enrollment

Registered

2009-02-27

Start date

1995-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus, insomnia Nervous System Diseases Sleep disorders

Interventions

In a randomised, double-blind, crossover study, the subjects were treated for 3 weeks with 1 tablet per night of 2 mg prolonged-release melatonin (Circadin®) (oral) or placebo, with one week washout p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Independently living male and female patients (no age limits) who complained of insomnia and suffer from diabetes.

Exclusion criteria

Exclusion criteria: Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).

Design outcomes

Primary

Measure	Time frame
Sleep efficiency (Time Frame: 3 weeks). Efficacy of sleep quality was objectively monitored by a wrist actigraphy device (Somnitor™). Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm.	—

Secondary

Measure	Time frame
Safety. Total duration of follow-up: 3 weeks	—

Countries

Israel

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026