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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00495885
First Posted: July 3, 2007
Last Update Posted: May 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose
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.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders Drug: volinanserin (M100907) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • change from baseline to 12 weeks for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change from baseline to 12-week of "General Productivity" domain from Functional Outcomes of Sleep Questionnaire (FOSQ). [ Time Frame: 12 weeks ]

Enrollment: 848
Study Start Date: June 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Volinanserin
Volinanserin 2 mg for a maximum of 87 days
Drug: volinanserin (M100907)
oral, one tablet taken around bedtime
Placebo Comparator: Placebo
Placebo for volinanserin for a maximum of 106 days
Drug: Placebo
oral, one tablet taken around bedtime

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495885


Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Colombia
Sanofi-Aventis Administrative Office
Santafe de Bogota, Colombia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00495885     History of Changes
Other Study ID Numbers: LTE6672
Eudract: 2006-006677-25
First Submitted: July 2, 2007
First Posted: July 3, 2007
Last Update Posted: May 26, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
Sleep problems
insomnia
sleeplessness
primary insomnia
insomnia disorder

Additional relevant MeSH terms:
Diabetes Mellitus
Sleep Initiation and Maintenance Disorders
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Volinanserin
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs