Diabetes Mellitus, Type 2Phase 2NCT00869128
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
A Phase 2 study testing Circadin in people with Diabetes Mellitus, Type 2 and Insomnia, run by Neurim Pharmaceuticals Ltd..
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insomnia
- What is being tested?
- Circadin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 1995to Mar 1997
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetic patients with proven presence of the disease who complained of insomnia.
Who cannot join
- Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Insomnia
- Being tested
- Circadin, Placebo
- Keywords
- melatonin, insomnia, diabetes, sleep
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircadinDrug
Also called Prolonged-release melatonin (2mg)
2 mg prolonged-release melatonin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo First | Other | Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin). Receives: Drug: Circadin; Drug: Placebo |
| Circadin first | Other | Subjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo. Receives: Drug: Circadin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startNov 1995
- Primary completionMar 1997
- Study completionMar 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurim Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Doron Garfinkel, MD, Principal investigator, Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869128
- Sponsor's protocol ID
- Neu951005
- Status last verified
- Mar 2009
- First submitted
- 8 Dec 2008
- Last updated
- 1 May 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00869128
- Acronym / sponsor ID
- Neu951005
- Conditions
- Diabetes Mellitus, Type 2, Insomnia
- Keywords
- melatonin, insomnia, diabetes, sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Neurim Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 1995
- Primary completion
- Mar 1997 (actual)
- Study completion
- Mar 1997 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Posted 25 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo First | Other | Drug: Circadin, Drug: PlaceboSubjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin). |
| Circadin first | Other | Drug: Circadin, Drug: PlaceboSubjects were treated for 3 weeks with 1 tablet per night of 2 mg melatonin (Circadin) and then with placebo. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients with proven presence of the disease who complained of insomnia.
Key exclusion criteria (1 listed)
- Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CircadinAlso: Prolonged-release melatonin (2mg)2 mg prolonged-release melatonin | Drug | Circadin first, Placebo First |
| Placebo | Drug | Circadin first, Placebo First |
Primary outcome
Sleep Efficiency
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doron Garfinkel, MD principal investigator
Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Circadin in people with Diabetes Mellitus, Type 2 and Insomnia, run by Neurim Pharmaceuticals Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2009.