Status:
COMPLETED
Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
Lead Sponsor:
CPEX Pharmaceuticals Inc.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The purpose of this study is: * To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia, assessed by continuous glucose monitoring data and serum fructosamine levels in...
Detailed Description
This proof of concept trial has a randomized, parallel, double-blind, placebo-controlled design with a 4-week single-blind placebo and diet run-in period. Given a ratio of 1:1, patient volunteers will...
Eligibility Criteria
Inclusion
- Adults with Type 2 diabetes (18 years of age or older)
- Currently treated with basal insulin and OAD(s)
- HbA1c range of 6.5 - 10.
- BMI less than 41
Exclusion
- Multiple daily injections of mealtime insulin
- Regular use of nasal sprays
- Significant nasal pathology
- Employed in a job which required irregular shift or night work
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00850096
Start Date
January 1 2009
End Date
March 1 2010
Last Update
December 13 2013
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Radiant Research
Chandler, Arizona, United States, 85225
2
AMCR Institute, Inc
Escondido, California, United States, 92026
3
Scripps Whittier Diabetes Clinic
La Jolla, California, United States, 92037
4
Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.
San Mateo, California, United States, 94401