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NCT00322257 Clinical Trial

Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Diabetes Clinical Trial

Official title:
Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00322257
Other study ID # NN1998-2076
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 1, 2006
Est. completion date April 2, 2008

Study information
Verified date September 2018
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

Description:

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Recruitment information / eligibility
Status Terminated
Enrollment 596
Est. completion date April 2, 2008
Est. primary completion date April 2, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Type 1 diabetes

- HbA1c less than or equal to 11%

- Body mass index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

- Total daily insulin dosage more than 100 IU or U/day.

- Current smoking or smoking within the last 6 months

- Impaired hepatic or renal function

- Cardiac problems

- Uncontrolled hypertension

- Current proliferative retinopathy or maculopathy requiring acute treatment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
• insulin detemir
Injection s.c., 50% of daily dose
• insulin aspart
Treat-to-target dose titration scheme, injection s.c.

Locations
Country Name City State
Canada Novo Nordisk Investigational Site Gatineau
Canada Novo Nordisk Investigational Site Laval Quebec
Canada Novo Nordisk Investigational Site Mississauga
Canada Novo Nordisk Investigational Site Montreal Quebec
Canada Novo Nordisk Investigational Site Penticton
Canada Novo Nordisk Investigational Site Red Deer
Canada Novo Nordisk Investigational Site St John's
Canada Novo Nordisk Investigational Site Vancouver
Canada Novo Nordisk Investigational Site Victoria British Columbia
Canada Novo Nordisk Investigational Site Winnipeg Manitoba
United States Novo Nordisk Investigational Site Albany New York
United States Novo Nordisk Investigational Site Asheville North Carolina
United States Novo Nordisk Investigational Site Athens Georgia
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Aurora Colorado
United States Novo Nordisk Investigational Site Baton Rouge Louisiana
United States Novo Nordisk Investigational Site Birmingham Alabama
United States Novo Nordisk Investigational Site Bloomington Minnesota
United States Novo Nordisk Investigational Site Boca Raton Florida
United States Novo Nordisk Investigational Site Butte Montana
United States Novo Nordisk Investigational Site Chattanooga Tennessee
United States Novo Nordisk Investigational Site Chattanooga Tennessee
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Cleveland Ohio
United States Novo Nordisk Investigational Site Colorado Springs Colorado
United States Novo Nordisk Investigational Site Concord California
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dayton Ohio
United States Novo Nordisk Investigational Site Des Moines Iowa
United States Novo Nordisk Investigational Site Dover New Hampshire
United States Novo Nordisk Investigational Site Duluth Minnesota
United States Novo Nordisk Investigational Site Encino California
United States Novo Nordisk Investigational Site Escondido California
United States Novo Nordisk Investigational Site Fresno California
United States Novo Nordisk Investigational Site Greenville North Carolina
United States Novo Nordisk Investigational Site Hampton New Hampshire
United States Novo Nordisk Investigational Site Hershey Pennsylvania
United States Novo Nordisk Investigational Site Hollywood Florida
United States Novo Nordisk Investigational Site Honolulu Hawaii
United States Novo Nordisk Investigational Site Honolulu Hawaii
United States Novo Nordisk Investigational Site Hyattsville Maryland
United States Novo Nordisk Investigational Site Idaho Falls Idaho
United States Novo Nordisk Investigational Site Inglewood California
United States Novo Nordisk Investigational Site Jefferson City Missouri
United States Novo Nordisk Investigational Site Kansas City Missouri
United States Novo Nordisk Investigational Site Kettering Ohio
United States Novo Nordisk Investigational Site La Jolla California
United States Novo Nordisk Investigational Site Lafayette Indiana
United States Novo Nordisk Investigational Site Lake Mary Florida
United States Novo Nordisk Investigational Site Lawrenceville New Jersey
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Medford Oregon
United States Novo Nordisk Investigational Site Melbourne Florida
United States Novo Nordisk Investigational Site Mentor Ohio
United States Novo Nordisk Investigational Site Merritt Island Florida
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site Midland Texas
United States Novo Nordisk Investigational Site Milwaukee Wisconsin
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Mission Viejo California
United States Novo Nordisk Investigational Site New Albany Indiana
United States Novo Nordisk Investigational Site New Britain Connecticut
United States Novo Nordisk Investigational Site New Hyde Park New York
United States Novo Nordisk Investigational Site Norristown Pennsylvania
United States Novo Nordisk Investigational Site Norwalk Connecticut
United States Novo Nordisk Investigational Site Ogden Utah
United States Novo Nordisk Investigational Site Olympia Washington
United States Novo Nordisk Investigational Site Omaha Nebraska
United States Novo Nordisk Investigational Site Peoria Illinois
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Poway California
United States Novo Nordisk Investigational Site Renton Washington
United States Novo Nordisk Investigational Site Rochester New York
United States Novo Nordisk Investigational Site Saint Louis Missouri
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Mateo California
United States Novo Nordisk Investigational Site Santa Barbara California
United States Novo Nordisk Investigational Site Savannah Georgia
United States Novo Nordisk Investigational Site Scarborough Maine
United States Novo Nordisk Investigational Site Shawnee Mission Kansas
United States Novo Nordisk Investigational Site Spokane Washington
United States Novo Nordisk Investigational Site Springfield Massachusetts
United States Novo Nordisk Investigational Site Springfield Illinois
United States Novo Nordisk Investigational Site Topeka Kansas
United States Novo Nordisk Investigational Site Tupelo Mississippi
United States Novo Nordisk Investigational Site Tuscaloosa Alabama
United States Novo Nordisk Investigational Site Tustin California
United States Novo Nordisk Investigational Site Vista California
United States Novo Nordisk Investigational Site Walnut Creek California
United States Novo Nordisk Investigational Site Waltham Massachusetts
United States Novo Nordisk Investigational Site Waterbury Connecticut
United States Novo Nordisk Investigational Site West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c After 52 weeks
Secondary Body weight after 52 weeks
Secondary Antibodies after 52 weeks
Secondary Hypoglycemia For the duration of the trial
Secondary Insulin doses For the duration of the trial
Secondary Pulmonary Function For the duration of the trial
Secondary Fasting plasma glucose after 52 weeks
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