Phase 2 N=36 Randomized Double-blind Treatment

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

Diabetes Mellitus, Type 2 · Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT00869128 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Mar 2009

Primary outcome: Primary: Sleep Efficiency — 79.5; 83.1 Percentage of time asleep — p=0.04

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Circadin (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Neurim Pharmaceuticals Ltd.
Primary completion: Mar 1997

Outcome Measures

Outcome	Result	p-value
PRIMARY Sleep Efficiency	79.5; 83.1	0.04 sig

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.

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00869128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.