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 22, 2025
Completed
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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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