Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.

Key facts

Study ID

NCT00495885

Run by

Sanofi

People needed

848

Starts

2007-06-01

Expected to finish

2008-10-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
• Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
• Sub-study :
• Patients will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)

You may not qualify if…

• 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, cola) comprising more than 5 cups/day
• Participation in another trial having received study medication within 1 month before the screening visit
• Body Mass Index ≥ 33
• Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
• Use of any substance with psychotropic effects or properties know to affect sleep/wake
• History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
• Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
• Positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Bogotá, Colombia
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Helsinki, Finland
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Kuala Lumpur, Malaysia
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Midrand, South Africa
• Sanofi-Aventis Administrative Office — Geneva, Switzerland
• Sanofi-Aventis Administrative Office — Taipei, Taiwan
• Sanofi-Aventis Administrative Office — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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