Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus (SAMS)

Sanofi

Status and phase

Terminated

Phase 3

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Drug: Placebo

Drug: Volinanserin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00464061

LTE6673

EudraCT : 2006-004942-18

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

1,847 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 participant's information related to sleep pattern during the preceding month

Sub-study :

Participants 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 participant's potential participation in a clinical trial.