Trial Outcomes & Findings for A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia (NCT NCT00869128)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

3 weeks

Results posted on

2009-05-01

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	18	18
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study lack of Compliance	6	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=36 Participants Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants
Age Continuous	63 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment Israel	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Subjects were treated for 3 weeks with 1 tablet per night of Placebo	Circadin n=24 Participants Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg
Sleep Efficiency	79.5 Percentage of time asleep Standard Deviation 9.6	83.1 Percentage of time asleep Standard Deviation 11.3

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

D. Garfinkel , MD

Shoham Geriatric Medical Center, Pardes Hana, Israel

Phone: Tel: 972-4-6375667

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place