Clinical trial NCT00850096: Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Phase 2 Study for novel insulin delivery of type 2 diabetes
Lead sponsor: CPEX Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-24
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

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 be randomized into one of two parallel treatment arms, Nasulin in a combination with insulin glargine or placebo in combination with insulin glargine. The randomization period will be 6 weeks in length. The total length of individual patient volunteer participation, including screening and follow-up will be approximately 13-14 weeks.

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

Primary outcomes:
measure: Continuous Glucose Monitoring (CGM)
timeFrame: Baseline and 5-6 weeks
Secondary outcomes:
measure: Overall Glycemic Control
timeFrame: 5-6 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Radiant Research
state: Arizona
city: Escondido
country: United States
facility: AMCR Institute, Inc
state: California
city: LaJolla
country: United States
facility: Scripps Whittier Diabetes Clinic
state: California
city: San Mateo
country: United States
facility: Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Diabetes Research Institute
state: Florida
city: W. Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Asheville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
city: Greenville
country: United States
facility: ECU Diabetes Research Center
state: North Carolina
city: Greenville
country: United States
facility: Physician's East PA
state: North Carolina
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Dallas
country: United States
facility: University of Texas; Southwestern Medical Center
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research
state: Washington
Study officials:
affiliation: CPEX Pharmaceuticals
name: Lance Berman, MD
role: STUDY_DIRECTOR
References: