Efficacy and safety of 2mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a 12-week, multi-center, randomized, double-blind, placebo-controlled study - SAMS 12 (Sleep And Metabolism Study, 12 weeks)

• Conditions: Sleep maintenance insomnia (+ subpopulation of stable type II Diabetes Mellitus)

• Registration Number: EUCTR2006-006677-25-CZ
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

*Related to patients:
-Out-patients >= 18 years of age or the legal age of consent in the area where the study is being done.
-Woman of childbearing potential (less than two years post-menopausal or not surgically sterile), must have a negative urine pregnancy test at screening – and must use a highly effective method of birth control for at least one month prior to screening, which is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs containing hormones, sexual abstinence (unless not acceptable by the local health authorities) or vasectomised partner.
*Related to sleep disorders:
-Each patient must have primary insomnia based on criteria (DSM IV-TR) with predominant complaints of difficulty in maintaining sleep (nocturnal awakenings or early morning awakenings), for at least one month preceding the study visit, and having clinically significant distress or impairment in social occupational or other important areas of functioning.
-Based on patient’s information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 4 or more nights per week over the preceding month.
-Based on patient’s information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks.
-Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening and randomization visits. To be included patient’s answer should be either: 2 (= Somewhat interfering), or 3 (= Much), or 4 (= Very Much Interfering) at both visits.
-Based on the information recorded in the patient’s sleep questionnaire during the screening week preceding the randomization the following criteria must be present:
•In the Screening Period (5 –10 days) more than a half (>50%) of nights must have WASO >= 60 min.
•TST <= 7 hours and >= 3 hours on 3-worst screening nights.
•Excluding one night in the Screening Period (5 – 10 days) with the highest Sleep Onset Latency (SOL) value, the mean SOL for the Screening Period must be <= 30 min.
*Related to Type II Diabetes Mellitus
-Patients with type II diabetes (WHO definition) must have been on an oral hypoglycemic agent(s) and/or insulin for at least 3 months prior to the Screening Visit (stable regimen for at least one month prior to Screening Visit).
NB: diabetic patients not fulfilling this criterion may nevertheless be enrolled in the study as part of the main study population but not in the substudy in diabetes.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

*Related to patients:
-Females who are lactating or who are pregnant.
-Night shift workers, and individuals who nap 3 or more times per week over the preceding month.
-Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day.
-Participation in another trial having received study medication within one month before the screening visit.
-Body mass index >= 33 calculated from patient’s height (m) and weight (kg); weight (kg)/height (m²).
-Use of any over-the-counter including tryptophan, valerian root (Valeriana officinalis), kava (Piper methysticum Forst), melatonin, St. John’s Wort (Hypericum perforatum), Alluna (herbal supplement with valerian root) or prescription sleep medication, including hypnotics and sedatives, and anxiolytics, within one week or five half-lives (whichever is longer), prior to screening.
-Use of any substance with psychotropic effects or properties known to affect sleep/wake, including, but not limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, within one week or five half-lives (whichever is longer), prior to screening.
-Patients unable to complete the study questionnaires.
-Patients unwilling to provide written, signed and dated informed consent must not be included in the study.
-Patients who are unable to participate for the entire duration of the study, or in the opinion of the investigator, are likely to be non-compliant with the obligations inherent in the trial participation.
*Related to sleep disorders:
-History of (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep disorder, (iv) circadian rhythm sleep disorder, (v) parasomnia (e.g. somnambulism), (vi) dyssomnia not otherwise specified, i.e., periodic leg movement syndrome.
*Related to concomitant illnesses:
-Patients presenting with acute or chronic pain resulting in insomnia.
-Patients with current psychiatric disturbances according to DSM IV criteria including but not limited to psychosis and/or bipolar disorder, obsessive compulsive disorder, major depression, anxiety disorders, panic disorders, eating disorder, alcohol or substance abuse or dependence -except nicotine-, or a history of lifetime psychosis and/or bipolar disorder.
-Patients with mental retardation or dementia.
-Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions).
-Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety.
-Clinically significant and abnormal ECG (including QTcF >= 500ms).
-Serious head injury or stroke within the past year.
-Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene) at screening.
*Related to Diabetes Mellitus Type II
-HbA1C level of >= 9.5% at the Screening Visit.
-HbA1C level of < or = to 6.5% at the Screening Visit. (Note: diabetic patients with HbA1C level of < or = to 6.5% may be included in the main study population).
-Fasting Plasma Glucose >= 250 mg/dL (14.0 mmol/L) at the Screening Visit.
-Patients with poorly controlled diabetes; i.e., a history of hospitalization for ketoacidosis within the past 12 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified