Phase 2 N=94 Randomized Triple-blind Treatment

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

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00850096 ↗

Enrolled (actual)

Serious AEs

5.3%

Results posted

May 2012

Primary outcome: Primary: Continuous Glucose Monitoring (CGM) — -6.23; -0.72 Percentage of day (24h) in euglycemia

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo for Nasulin (Other); Nasulin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CPEX Pharmaceuticals Inc.
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Continuous Glucose Monitoring (CGM)	-6.23; -0.72	—
SECONDARY Overall Glycemic Control	174.64; 163.34	—

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00850096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.