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

November 25, 2013 updated by: CPEX Pharmaceuticals Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Intranasal insulin spray 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous Glucose Monitoring (CGM)
Time Frame: Baseline and 5-6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Glycemic Control
Time Frame: 5-6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CPEX Pharmaceuticals Inc.

Investigators

  • Study Director: Lance Berman, MD, CPEX Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (ESTIMATE)

February 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-0100-CPEX011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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