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

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ClinicalTrials.gov Identifier: NCT00464061
Recruitment Status : Terminated (Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems)
First Posted : April 20, 2007
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: Volinanserin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1847 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Volinanserin Drug: Volinanserin
oral administration
Other Name: M100907

Placebo Comparator: Placebo Drug: Placebo
oral administration




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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.


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): NCT00464061


  Show 22 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00464061     History of Changes
Other Study ID Numbers: LTE6673
EudraCT : 2006-004942-18
First Posted: April 20, 2007    Key Record Dates
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