Trial Information

Summary: Phase III, Double-blind, Sleep Maintenance study with Stable Diabetes Type II. Treatment is with investigational medication.

This study is for subjects that have problems staying asleep but not falling asleep and has Type II diabetes under control of oral medication. This study is outpatient with visits that vary from weekly to monthly.

Patient Inclusion Criteria:

• Able to read and speak English
• Insomnia
• Diabetes Type II
• BMI of 33
• Generally Healthy
• Age 18 and up
• Women of Child Bearing potential need to be abstinent, Surgically sterile, or using birth control method that has a less than 1% failure rate.

Patient Exclusion Criteria:

• Any other Diagnosis
• Females who are pregnant or lactating
• Consume more than 5 cups of caffeine per day
• Use of any substance with psychotropic effects or preperties known to affect sleep/wake.
• History of epilepsy or seizures
• Drug abuse

Primary Outcomes: Questionnaires and automated phone questionnaires

If you would like to learn more about participating in this study, please send an e-mail message using the form below.