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

This study has been completed.

Sponsor:

Information provided by:

Neurim Pharmaceuticals Ltd.

ClinicalTrials.gov Identifier:

NCT00869128

First received: December 8, 2008

Last updated: March 30, 2009

Last verified: March 2009

History of Changes

Results First Received: December 8, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Diabetes Mellitus, Type 2 Insomnia
Interventions:	Drug: Circadin Drug: Placebo

Participant Flow

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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

	Description
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
NOT COMPLETED	6	6
lack of Compliance	6	6

Baseline Characteristics

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Reporting Groups

	Description
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
Number of Participants [units: participants]	36
Age [units: participants]
<=18 years	0
Between 18 and 65 years	14
>=65 years	22
Age [units: years] Mean ± Standard Deviation	63 ± 8
Gender [units: participants]
Female	25
Male	11
Region of Enrollment [units: participants]
Israel	36

Outcome Measures

1. Primary:

Sleep Efficiency [ Time Frame: 3 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

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
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Results Point of Contact:

Name/Title: D. Garfinkel , MD
Organization: Shoham Geriatric Medical Center, Pardes Hana, Israel
phone: Tel: 972-4-6375667
e-mail: dorong@shoham.health.gov.il

No publications provided

Responsible Party:	Dr. Doron Garfinkel, Shoham Geriatric Medical Center,Pardes Hana 37000, Israel
ClinicalTrials.gov 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
Health Authority:	Israel: Ministry of Health

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