Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: NasulinOther: Placebo for Nasulin
- Registration Number
- NCT00850096
- Lead Sponsor
- CPEX Pharmaceuticals Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nasulin Nasulin Nasulin (intranasal insulin spray 1%) Placebo for Nasulin Placebo for Nasulin Placebo for Nasulin Spray
- Primary Outcome Measures
Name Time Method Continuous Glucose Monitoring (CGM) Baseline and 5-6 weeks Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.
- Secondary Outcome Measures
Name Time Method Overall Glycemic Control 5-6 weeks Continuous glucose monitoring (CGM) data from patients at the last weeks of study (week 5-6) were averaged for assessment of glycemic control under the treatment of either Nasulin or placebo.
Trial Locations
- Locations (21)
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Mountain Diabetes and Endocrine Center
🇺🇸Asheville, North Carolina, United States
ECU Diabetes Research Center
🇺🇸Greenville, North Carolina, United States
Physician's East PA
🇺🇸Greenville, North Carolina, United States
University of Rochester
🇺🇸Rochester, New York, United States
Metabolic Research Institute
🇺🇸W. Palm Beach, Florida, United States
Scripps Whittier Diabetes Clinic
🇺🇸LaJolla, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
AMCR Institute, Inc
🇺🇸Escondido, California, United States
Rainier Clinical Research
🇺🇸Renton, Washington, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
Texas Diabetes and Endocrinology
🇺🇸Austin, Texas, United States
Barbara Davis Center
🇺🇸Aurora, Colorado, United States
University of Miami Diabetes Research Institute
🇺🇸Miami, Florida, United States
Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.
🇺🇸San Mateo, California, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Texas; Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Radiant Research
🇺🇸Chandler, Arizona, United States