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

NCT ID: NCT00850096

Last Updated: 2013-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Keywords

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Phase 2 Study for novel insulin delivery of type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo for Nasulin

Placebo for Nasulin Spray

Group Type PLACEBO_COMPARATOR

Placebo for Nasulin

Intervention Type OTHER

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.

Nasulin

Nasulin (intranasal insulin spray 1%)

Group Type ACTIVE_COMPARATOR

Nasulin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DRUG

Other Intervention Names

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Intranasal insulin spray 1%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CPEX Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lance Berman, MD

Role: STUDY_DIRECTOR

CPEX Pharmaceuticals

Locations

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Radiant Research

Chandler, Arizona, United States

Site Status

AMCR Institute, Inc

Escondido, California, United States

Site Status

Scripps Whittier Diabetes Clinic

La Jolla, California, United States

Site Status

Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.

San Mateo, California, United States

Site Status

Diablo Clinical Research

Walnut Creek, California, United States

Site Status

Barbara Davis Center

Aurora, Colorado, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

University of Miami Diabetes Research Institute

Miami, Florida, United States

Site Status

Metabolic Research Institute

West Palm Beach, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status

Maine Research Associates

Auburn, Maine, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, United States

Site Status

ECU Diabetes Research Center

Greenville, North Carolina, United States

Site Status

Physician's East PA

Greenville, North Carolina, United States

Site Status

Texas Diabetes and Endocrinology

Austin, Texas, United States

Site Status

University of Texas; Southwestern Medical Center

Dallas, Texas, United States

Site Status

Rainier Clinical Research

Renton, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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US-0100-CPEX011

Identifier Type: -

Identifier Source: org_study_id