Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus (SAMS12)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Placebo; Drug: volinanserin (M100907)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00495885

LTE6672

Eudract: 2006-006677-25

Details and patient eligibility

About

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.

Enrollment: 848 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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848 participants in 2 patient groups, including a placebo group

Volinanserin

Experimental group

Description:

Volinanserin 2 mg for a maximum of 87 days

Treatment:

Drug: volinanserin (M100907)

Placebo

Placebo Comparator group

Description:

Placebo for volinanserin for a maximum of 106 days

Treatment:

Drug: Placebo