CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
Nasulin +1 moredrug
Likely dose
Nasulin 50 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00850096
NCT00850096Phase 2Completed
CompareCT.gov

Effects of Nasulin v.Placebo on Blood Glucose Control in Patients With Type 2 DM Treated With Basal Insulin & Oral Antidiabetic Meds, Excluding Secretagogues in Phase 2A, Randomized, Parallel, Double-Blind, Placebo-Controlled, Multi-Center Study

CPEX Pharmaceuticals Inc.·interventional·Posted Feb 24, 2009·Updated Dec 13, 2013

In Brief

A Phase 2 clinical trial evaluating Placebo for Nasulin and Nasulin for Type 2 Diabetes. Completed, enrolled 94 participants across 21 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2009
Enrollment StartJan 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.4 years ago

Interventions

Placebo for Nasulinother

Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.

Nasulindrug

Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.