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Clinical Trial NCT00850096 (CPEX-011) for Type 2 Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus (CPEX-011) Phase 2 94
Clinical Trial NCT00850096 (CPEX-011) was designed to study Treatment for Type 2 Diabetes. This was a Phase 2 interventional study that is now completed. The study started on 1 January 2009, with plans to enroll 94 participants. Led by CPEX Pharmaceuticals Inc., the expected completion date was 1 March 2010. The latest data from ClinicalTrials.gov was last updated on 13 December 2013.
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...Show More
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
Conditions
Type 2 DiabetesOther Study IDs
- CPEX-011
- US-0100-CPEX011
NCT ID Number
Start Date (Actual)
2009-01
Last Update Posted
2013-12-13
Completion Date (Estimated)
2010-03
Enrollment (Estimated)
94
Study Type
Interventional
PHASE
Phase 2
Status
Completed
Keywords
Phase 2 Study for novel insulin delivery of type 2 diabetes
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Placebo ComparatorPlacebo for Nasulin Placebo for Nasulin Spray | Placebo for Nasulin 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. |
Active ComparatorNasulin Nasulin (intranasal insulin spray 1%) | Nasulin 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Continuous Glucose Monitoring (CGM) | 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. | Baseline and 5-6 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Glycemic Control | 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. | 5-6 weeks |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
CPEX Pharmaceuticals Inc.No contact data.
21 Study Locations in 1 Countries
Arizona
Radiant Research, Chandler, Arizona, 85225, United States
California
AMCR Institute, Inc, Escondido, California, 92026, United States
Scripps Whittier Diabetes Clinic, La Jolla, California, 92037, United States
Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst., San Mateo, California, 94401, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Colorado
Barbara Davis Center, Aurora, Colorado, 80045, United States
Florida
Clinical Research of West Florida, Clearwater, Florida, 33765, United States
University of Miami Diabetes Research Institute, Miami, Florida, 33136, United States
Metabolic Research Institute, West Palm Beach, Florida, 33401, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States
Hawaii
East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States
Idaho
Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404-7596, United States
Maine
Maine Research Associates, Auburn, Maine, 04210, United States
Missouri
Washington University, St Louis, Missouri, 63110, United States
New York
University of Rochester, Rochester, New York, 14642, United States
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
ECU Diabetes Research Center, Greenville, North Carolina, 27834, United States
Physician's East PA, Greenville, North Carolina, 27834, United States
Texas
Texas Diabetes and Endocrinology, Austin, Texas, 78731, United States
University of Texas; Southwestern Medical Center, Dallas, Texas, 75390, United States
Washington
Rainier Clinical Research, Renton, Washington, 98057, United States