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:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00495885
First received: July 2, 2007
Last updated: September 22, 2009
Last verified: September 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Efficacy: change from baseline to 12 weeks for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Efficacy (sub-study): change from baseline to 12 week-treatment for glycemic measure HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety: adverse events and laboratory abnormalities [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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: 1 Drug: volinanserin (M100907)
one tablet taken around bedtime
Placebo Comparator: 2 Drug: Placebo
one tablet taken around bedtime

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00495885     History of Changes
Other Study ID Numbers: LTE6672, Eudract: 2006-006677-25
Study First Received: July 2, 2007
Last Updated: September 22, 2009
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
Netherlands: Medicines Evaluation Board (MEB)

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
MDL 100907
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014