Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

— CPEX-011  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850096
• Other study ID #: US-0100-CPEX011
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2009
• Last updated: November 25, 2013
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2013
• Source: CPEX Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Mountain Diabetes and Endocrine Center	Asheville	North Carolina
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Maine Research Associates	Auburn	Maine
United States	Barbara Davis Center	Aurora	Colorado
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	Radiant Research	Chandler	Arizona
United States	Clinical Research of West Florida	Clearwater	Florida
United States	University of Texas; Southwestern Medical Center	Dallas	Texas
United States	AMCR Institute, Inc	Escondido	California
United States	ECU Diabetes Research Center	Greenville	North Carolina
United States	Physician's East PA	Greenville	North Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Scripps Whittier Diabetes Clinic	LaJolla	California
United States	University of Miami Diabetes Research Institute	Miami	Florida
United States	Rainier Clinical Research	Renton	Washington
United States	University of Rochester	Rochester	New York
United States	Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.	San Mateo	California
United States	Washington University	St. Louis	Missouri
United States	Metabolic Research Institute	W. Palm Beach	Florida
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
CPEX Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes