Phase 2
Completed N=94
Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00850096 ↗Enrolled (actual)
94
Serious AEs
5.3%
Results posted
May 2012
Primary outcomePrimary: Continuous Glucose Monitoring (CGM) — -6.23; -0.72 Percentage of day (24h) in euglycemia
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Glucose Monitoring (CGM) |
-6.23; -0.72 | — |
| SECONDARY Overall Glycemic Control |
174.64; 163.34 | — |
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
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. Informational only — not medical advice.