Efficacy of prolonged-release melatonin versus placebo in a three-week treatment of diabetic patients suffering from insomnia
| ISRCTN | ISRCTN55944464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55944464 |
| Protocol serial number | Neu951005 |
| Sponsor | Neurim Pharmaceuticals Ltd. (Israel) |
| Funder | Neurim Pharmaceuticals Ltd. (Isreal) |
- Submission date
- 25/02/2009
- Registration date
- 27/02/2009
- Last edited
- 27/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Moshe Laudon
Scientific
Scientific
Neurim Pharmaceuticals Ltd.
27 Habarzel St.
Tel Aviv
69710
Israel
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised double-blind, crossover study comparing the efficacy of prolonged-release melatonin versus placebo in a three-week treatment of diabetic patients suffering from insomnia |
| Study objectives | 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. |
| Ethics approval(s) | Ethics Committee of the E. Wolfson Medical Centre Holon, approved on 01/11/1995 (ref: 5471) |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus, insomnia |
| Intervention | In a randomised, double-blind, crossover study, the subjects were treated for 3 weeks with 1 tablet per night of 2 mg prolonged-release melatonin (Circadin®) (oral) or placebo, with one week washout period in between. |
| Intervention type | Other |
| Primary outcome measure(s) |
Sleep efficiency (Time Frame: 3 weeks). Efficacy of sleep quality was objectively monitored by a wrist actigraphy device (Somnitor™). Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm. |
| Key secondary outcome measure(s) |
Safety. Total duration of follow-up: 3 weeks |
| Completion date | 01/03/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 36 |
| Key inclusion criteria | Independently living male and female patients (no age limits) who complained of insomnia and suffer from diabetes. |
| Key exclusion criteria | Patients with liver or renal problems (serum creatinine above 1.5 mg/dL). |
| Date of first enrolment | 01/11/1995 |
| Date of final enrolment | 01/03/1997 |
Locations
Countries of recruitment
- Israel
Study participating centre
Neurim Pharmaceuticals Ltd.
Tel Aviv
69710
Israel
69710
Israel
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
