This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Neurim Pharmaceuticals Ltd. Identifier:
First received: December 8, 2008
Last updated: March 30, 2009
Last verified: March 2009
Results First Received: December 8, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Interventions: Drug: Circadin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
36 independently living patients who complained of insomnia and suffered from type 2 diabetes (16 treated with oral hypoglycemic agents and 20 on insulin) entered the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with liver or renal disease (serum creatinine 1.5 mg/dL or higher) were excluded. All 36 patients were randomized and all concluded the crossover randomized and extension parts of the study.

Reporting Groups
Placebo First Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
Circadin First Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg and then with Placebo.

Participant Flow:   Overall Study
    Placebo First   Circadin First
STARTED   18   18 
COMPLETED   12   12 
lack of Compliance                6                6 

  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Entire Study Population Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   14 
>=65 years   22 
[Units: Years]
Mean (Standard Deviation)
 63  (8) 
[Units: Participants]
Female   25 
Male   11 
Region of Enrollment 
[Units: Participants]
Israel   36 

  Outcome Measures

1.  Primary:   Sleep Efficiency   [ Time Frame: 3 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: D. Garfinkel , MD
Organization: Shoham Geriatric Medical Center, Pardes Hana, Israel
phone: Tel: 972-4-6375667

Responsible Party: Dr. Doron Garfinkel, Shoham Geriatric Medical Center,Pardes Hana 37000, Israel Identifier: NCT00869128     History of Changes
Other Study ID Numbers: Neu951005
Study First Received: December 8, 2008
Results First Received: December 8, 2008
Last Updated: March 30, 2009