Clinical trial NCT00411892: Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes
Official title: Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-12-15
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
* HbA1c between 7.0-11.0% if on OAD monotherapy
* HbA1c between 7.0-10.0% if on OAD combination therapy
* BMI less than or equal to 40 kg/m2

Exclusion Criteria:

* Current regular smoking or regular smoking within the last 6 months
* Current acute or chronic pulmonary disease (except for asthma)
* Proliferative retinopathy requiring treatment
* Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity
* Pregnancy

Primary outcomes:
measure: HbA1c change from baseline
timeFrame: After 26 weeks of treatment
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: after 26 weeks of treatment
measure: Lipid profiles
timeFrame: after 26 weeks of treatment
measure: Frequency of hypoglycaemic episodes
timeFrame: after 26 weeks of treatment
measure: Glucose profiles
timeFrame: at pre- and post meals, bedtime and 3:00 am
measure: Change in body weight
timeFrame: after 26 weeks of treatment
Other outcomes:
Locations:
city: Ozark
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Vestavia Hills
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Bermuda Dunes
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Escondido
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: La Jolla
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Northridge
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Orange
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Orange
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Poway
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Roseville
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Sacramento
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Santa Barbara
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Temecula
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Tustin
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Arvada
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Beverly Hills
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Boca Raton
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Lake Mary
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Marianna
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Niceville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Panama City
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Athens
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Blue Ridge
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Dunwoody
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Powder Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Suwanee
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Tucker
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Boise
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Avon
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Lafayette
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Prince Frederick
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Marlborough
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Waltham
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Bloomington
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: Novo Nordisk Investigational Site
state: Mississippi
city: Chesterfield
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Billings
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Syracuse
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Novo Nordisk Investigational Site
state: North Dakota
city: Canal Fulton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Clinton
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Altoona
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Beaver
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Bensalem
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Clarksville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Lewisville
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Saint George
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Warrenton
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: