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Search / Trial NCT00869128

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

Launched by NEURIM PHARMACEUTICALS LTD. · Mar 24, 2009

Trial Information

Current as of May 01, 2025

Completed

Keywords

Melatonin Insomnia Diabetes Sleep

ClinConnect Summary

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.

Gender

ALL

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).

About Neurim Pharmaceuticals Ltd.

Neurim Pharmaceuticals Ltd. is a biotechnology company specializing in the development of innovative therapies for central nervous system disorders. With a focus on addressing unmet medical needs, Neurim leverages advanced research and clinical expertise to create novel treatments that enhance patient outcomes. The company is committed to rigorous clinical trials and regulatory compliance, ensuring the safety and efficacy of its products. Neurim's portfolio includes therapies aimed at improving sleep quality and managing neurodegenerative conditions, reflecting its dedication to advancing healthcare through scientific innovation.

Locations

Patients applied

0 patients applied

Trial Officials

Doron Garfinkel, MD

Principal Investigator

Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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