NCT00495885

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 848 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DRUG	volinanserin (M100907)	oral, one tablet taken around bedtime
DRUG	Placebo	oral, one tablet taken around bedtime

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-07-03
• Last updated: 2016-05-26

Locations

16 sites across 16 countries: United States, Brazil, Canada, Colombia, Czechia, Finland, France, Greece, Italy, Malaysia, Netherlands, Russia, South Africa, Switzerland, Taiwan, Turkey (Türkiye)