Diabetes Mellitus, Type 2, Insomnia
Conditions
Keywords
melatonin, insomnia, diabetes, sleep
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.
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.
Interventions
DRUGCircadin
2 mg prolonged-release melatonin
DRUGPlacebo
Sponsors
Neurim Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | lack of Compliance | 6 | 6 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 22 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age Continuous | 63 years STANDARD_DEVIATION 8 |
| Region of Enrollment Israel | 36 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 11 Participants |
Outcome results
Primary
Sleep Efficiency
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sleep Efficiency | 79.5 Percentage of time asleep | Standard Deviation 9.6 |
| Circadin | Sleep Efficiency | 83.1 Percentage of time asleep | Standard Deviation 11.3 |
Comparison: ANOVA, The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.p-value: 0.04ANOVA