Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
CPEX-011
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
1 other identifier
interventional
94
1 country
21
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Jan 2009
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 30, 2009
CompletedFirst Posted
Study publicly available on registry
February 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
May 15, 2012
CompletedDecember 13, 2013
November 1, 2013
1.2 years
January 30, 2009
February 14, 2012
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Overall Glycemic Control
5-6 weeks
Study Arms (2)
Placebo for Nasulin
PLACEBO COMPARATORPlacebo for Nasulin Spray
Nasulin
ACTIVE COMPARATORNasulin (intranasal insulin spray 1%)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Radiant Research
Chandler, Arizona, 85225, United States
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
Barbara Davis Center
Aurora, Colorado, 80045, United States
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
Atlanta Diabetes Associates
Atlanta, Georgia, 30309, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404-7596, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Washington University
St Louis, Missouri, 63110, United States
University of Rochester
Rochester, New York, 14642, United States
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 Diabetes and Endocrinology
Austin, Texas, 78731, United States
University of Texas; Southwestern Medical Center
Dallas, Texas, 75390, United States
Rainier Clinical Research
Renton, Washington, 98057, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- CPEX Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Lance Berman, MD
CPEX Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2009
First Posted
February 24, 2009
Study Start
January 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
December 13, 2013
Results First Posted
May 15, 2012
Record last verified: 2013-11