Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus (CPEX-011)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CPEX Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00850096
First received: January 30, 2009
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes
Other: Placebo for Nasulin
Drug: Nasulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by CPEX Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Continuous Glucose Monitoring (CGM) [ Time Frame: Baseline and 5-6 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Overall Glycemic Control [ Time Frame: 5-6 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 94
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo for Nasulin
Placebo for Nasulin Spray
Other: 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 Comparator: Nasulin
Nasulin (intranasal insulin spray 1%)
Drug: 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.
Other Name: Intranasal insulin spray 1%

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850096

Locations
United States, Arizona
Radiant Research
Chandler, Arizona, United States, 85225
United States, California
AMCR Institute, Inc
Escondido, California, United States, 92026
Scripps Whittier Diabetes Clinic
LaJolla, California, United States, 92037
Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.
San Mateo, California, United States, 94401
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
University of Miami Diabetes Research Institute
Miami, Florida, United States, 33136
Metabolic Research Institute
W. Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States, 83404-7596
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803
ECU Diabetes Research Center
Greenville, North Carolina, United States, 27834
Physician's East PA
Greenville, North Carolina, United States, 27834
United States, Texas
Texas Diabetes and Endocrinology
Austin, Texas, United States, 78731
University of Texas; Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Rainier Clinical Research
Renton, Washington, United States, 98057
Sponsors and Collaborators
CPEX Pharmaceuticals Inc.
Investigators
Study Director: Lance Berman, MD CPEX Pharmaceuticals
  More Information

No publications provided

Responsible Party: CPEX Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00850096     History of Changes
Other Study ID Numbers: US-0100-CPEX011
Study First Received: January 30, 2009
Results First Received: February 14, 2012
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CPEX Pharmaceuticals Inc.:
Phase 2 Study for novel insulin delivery of type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014