Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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 patient volunteers with Type 2 Diabetes.

• To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient volunteers with Type 2 Diabetes

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CPEX Pharmaceuticals Inc.
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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