Phase 2
Completed N=36
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
Source: ClinicalTrials.gov NCT00869128 ↗Enrolled (actual)
36
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Sleep Efficiency — 79.5; 83.1 Percentage of time asleep — p=0.04
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Efficiency |
79.5; 83.1 | 0.04 sig |
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).
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. Informational only — not medical advice.