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

Sleep Initiation and Maintenance Disorders Clinical Trial

— SAMS12  

Official title:

Efficacy and Safety of 2 mg/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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00495885
• Other study ID #: LTE6672
• Secondary ID: Eudract: 2006-00
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2007
• Last updated: September 22, 2009
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilNetherlands: Medicines Evaluation Board (MEB)
• 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: Completed
• Enrollment: 848
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• 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, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• volinanserin (M100907)
one tablet taken around bedtime
• Placebo
one tablet taken around bedtime

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Canada	Sanofi-Aventis Administrative Office	Laval
Colombia	Sanofi-Aventis Administrative Office	Santafe de Bogota
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Greece	Sanofi-Aventis Administrative Office	Athens
Italy	Sanofi-Aventis Administrative Office	Milan
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
South Africa	Sanofi-Aventis Administrative Office	Midrand
Switzerland	Sanofi-Aventis Administrative Office	Geneva
Taiwan	Sanofi-Aventis Administrative Office	Taipei
Turkey	Sanofi-Aventis Administrative Office	Istanbul
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Colombia,  Czech Republic,  Finland,  France,  Greece,  Italy,  Malaysia,  Netherlands,  Russian Federation,  South Africa,  Switzerland,  Taiwan,  Turkey, 

Outcome

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