Trials / Completed
CompletedNCT00869128
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Neurim Pharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Circadin | 2 mg prolonged-release melatonin |
| DRUG | Placebo |
Timeline
- Start date
- 1995-11-01
- Primary completion
- 1997-03-01
- Completion
- 1997-03-01
- First posted
- 2009-03-25
- Last updated
- 2009-05-01
- Results posted
- 2009-03-25
Source: ClinicalTrials.gov record NCT00869128. Inclusion in this directory is not an endorsement.