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

April 26, 2016 updated by: Sanofi

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1847

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis Administrative Office
  • Australia
      • Macquarie Park, Australia
        • Sanofi-Aventis Administrative Office
  • Austria
      • Vienna, Austria
        • Sanofi-Aventis Administrative Office
  • Belgium
      • Diegem, Belgium
        • Sanofi-Aventis Administrative Office
  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis Administrative Office
  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • Chile
      • Santiago, Chile
        • Sanofi-Aventis Administrative Office
  • Colombia
      • Santafe de Bogota, Colombia
        • Sanofi-Aventis Administrative Office
  • Czech Republic
      • Praha, Czech Republic
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Hong Kong
      • Causeway Bay, Hong Kong
        • Anofi-Aventis Administrative Office
  • India
      • Mumbai, India
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanofi-Aventis Administrative Office
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Sanofi-Aventis Administrative Office
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis Administrative Office
  • Russian Federation
      • Moscow, Russian Federation
        • Sanofi-Aventis Administrative Office
  • Singapore
      • Singapore, Singapore
        • Sanofi-Aventis Administrative Office
  • South Africa
      • Midrand, South Africa
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis Administrative Office
  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
oral administration
EXPERIMENTAL: Volinanserin
Drug: Volinanserin
oral administration
Other Names:
  • M100907

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
Time Frame: at 3 months
at 3 months
Efficacy (sub-study): change from baseline for glycemic measure HbA1c
Time Frame: at 6 and 12 months
at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: change from baseline of the pr-WASO
Time Frame: at 6 and 12 months
at 6 and 12 months
Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire
Time Frame: at 3 months
at 3 months
Safety: adverse events and laboratory abnormalities
Time Frame: during 12 months of treatment
during 12 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

April 19, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (ESTIMATE)

April 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 26, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTE6673
  • EudraCT : 2006-004942-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe