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

Sleep Initiation and Maintenance Disorders Clinical Trial

— SAMS  

Official title:

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 One Year, Multi-center, Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00464061
• Other study ID #: LTE6673
• Secondary ID: EudraCT : 2006-0
• Status: Terminated
• Phase: Phase 3
• First received: April 19, 2007
• Last updated: August 27, 2009
• Start date: April 2007
• Est. completion date: March 2009

Study information

• Verified date: August 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaItaly: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1847
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• volinanserin (M100907)
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	Sanofi-Aventis Administrative Office	Macquarie Park
Austria	Sanofi-Aventis Administrative Office	Vienna
Belgium	Sanofi-Aventis Administrative Office	Diegem
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
Colombia	Sanofi-Aventis Administrative Office	Santafe de Bogota
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Germany	Sanofi-Aventis Administrative Office	Berlin
Hong Kong	Anofi-Aventis Administrative Office	Causeway Bay
India	Sanofi-Aventis Administrative Office	Mumbai
Italy	Sanofi-Aventis Administrative Office	Milano
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Mexico	Sanofi-Aventis Administrative Office	Mexico
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Singapore	Sanofi-Aventis Administrative Office	Singapore
South Africa	Sanofi-Aventis Administrative Office	Midrand
Spain	Sanofi-Aventis Administrative Office	Barcelona
Turkey	Sanofi-Aventis Administrative Office	Istanbul
United Kingdom	Sanofi-Aventis Administrative Office	Guildford	Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Czech Republic,  Germany,  Hong Kong,  India,  Italy,  Malaysia,  Mexico,  Russian Federation,  Singapore,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)		at 3 months	No
Primary	Efficacy (sub-study): change from baseline for glycemic measure HbA1c		at 6 and 12 months	No
Secondary	Efficacy: change from baseline of the pr-WASO		at 6 and 12 months	No
Secondary	Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire		at 3 months	No
Secondary	Safety: adverse events and laboratory abnormalities		during 12 months of treatment	Yes