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

• Sponsor: Neurim Pharmaceuticals Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00869128
• Collaborator: (none)
• Enrollment: 36
• Arms: 2
• Duration (Months): 16

Study Details

Study Description

Brief Summary

Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Insomnia	Drug: Circadin; Drug: Placebo	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Double-Blind, Crossover Study Comparing the Efficacy of Prolonged-Release Melatonin Versus Placebo in a 3 Week Treatment of Diabetic Patients Suffering From Insomnia
• Study Start Date: Nov 1, 1995
• Actual Primary Completion Date: Mar 1, 1997
• Actual Study Completion Date: Mar 1, 1997

Arms and Interventions

Arm	Intervention/Treatment
Other: Placebo First Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).	Drug: Circadin; 2 mg prolonged-release melatonin; Other Names: Prolonged-release melatonin (2mg) ; Drug: Placebo
Other: Circadin first Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo.	Drug: Circadin; 2 mg prolonged-release melatonin; Other Names: Prolonged-release melatonin (2mg) ; Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Sleep Efficiency [3 weeks]

   Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Neurim Pharmaceuticals Ltd.

Investigators

• Principal Investigator: Doron Garfinkel, MD, Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00869128
• Other Study ID Numbers: Neu951005
• First Posted: Mar 25, 2009
• Last Update Posted: May 1, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: melatonin; insomnia; diabetes; sleep
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Diabetes Mellitus, Type 2; Melatonin

Study Results

Participant Flow

Recruitment Details	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 Detail	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.

Arm/Group Title	Placebo First	Circadin First
Arm/Group Description	Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).	Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg and then with Placebo.
Period Title: Overall Study
STARTED	18	18
COMPLETED	12	12
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.
Overall Participants	36
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 38.9%
>=65 years	22 61.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (8)
Sex: Female, Male (Count of Participants)
Female	25 69.4%
Male	11 30.6%
Region of Enrollment (participants) [Number]
Israel	36 100%

Outcome Measures

1. Primary Outcome

Title	Sleep Efficiency
Description	Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Placebo	Circadin
Arm/Group Description	Subjects were treated for 3 weeks with 1 tablet per night of Placebo	Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg
Measure Participants	24	24
Mean (Standard Deviation) [Percentage of time asleep]	79.5 (9.6)	83.1 (11.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Circadin
	Comments	ANOVA, The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	ANOVA
	Comments	The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.

Adverse Events

Limitations/Caveats

[Not Specified]

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.