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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869128
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : March 25, 2009
Last Update Posted : May 1, 2009
Information provided by:
Neurim Pharmaceuticals Ltd.

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

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

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

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

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
First Submitted: December 8, 2008
First Posted: March 25, 2009
Results First Submitted: December 8, 2008
Results First Posted: March 25, 2009
Last Update Posted: May 1, 2009