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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo for Nasulin
Nasulin
Sponsored by
CPEX Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Phase 2 Study for novel insulin delivery of type 2 diabetes

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiant Research
  • AMCR Institute, Inc
  • Scripps Whittier Diabetes Clinic
  • Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.
  • Diablo Clinical Research
  • Barbara Davis Center
  • Clinical Research of West Florida
  • University of Miami Diabetes Research Institute
  • Metabolic Research Institute
  • Atlanta Diabetes Associates
  • East-West Medical Research Institute
  • Rocky Mountain Clinical Research
  • Maine Research Associates
  • Washington University
  • University of Rochester
  • Mountain Diabetes and Endocrine Center
  • ECU Diabetes Research Center
  • Physician's East PA
  • Texas Diabetes and Endocrinology
  • University of Texas; Southwestern Medical Center
  • Rainier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo for Nasulin

Nasulin

Arm Description

Placebo for Nasulin Spray

Nasulin (intranasal insulin spray 1%)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 30, 2009
Last Updated
November 25, 2013
Sponsor
CPEX Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00850096
Brief Title
Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CPEX Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Phase 2 Study for novel insulin delivery of type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo for Nasulin
Arm Type
Placebo Comparator
Arm Description
Placebo for Nasulin Spray
Arm Title
Nasulin
Arm Type
Active Comparator
Arm Description
Nasulin (intranasal insulin spray 1%)
Intervention Type
Other
Intervention Name(s)
Placebo for Nasulin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nasulin
Other Intervention Name(s)
Intranasal insulin spray 1%
Intervention Description
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 Measure Information:
Title
Continuous Glucose Monitoring (CGM)
Description
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.
Time Frame
Baseline and 5-6 weeks
Secondary Outcome Measure Information:
Title
Overall Glycemic Control
Description
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.
Time Frame
5-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Berman, MD
Organizational Affiliation
CPEX Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
AMCR Institute, Inc
City
Escondido
State/Province
California
ZIP/Postal Code
92026
Country
United States
Facility Name
Scripps Whittier Diabetes Clinic
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University of Miami Diabetes Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Metabolic Research Institute
City
W. Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7596
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Mountain Diabetes and Endocrine Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
ECU Diabetes Research Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Physician's East PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Texas Diabetes and Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
University of Texas; Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Rainier Clinical Research
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

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

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