Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: pioglitazone Drug: inhaled human insulin	Phase III

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Pioglitazone Pioglitazone hydrochloride Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c change from baseline [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting plasma glucose [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
lipid profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
frequency of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
glucose profiles [ Time Frame: at pre- and post meals, bedtime and 3:00 am ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	196
Study Start Date:	December 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: pioglitazone Tablets, 45 mg/day. Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation.
B: Active Comparator	Drug: pioglitazone Tablets, 45 mg/day.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411892

Show 95 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Theresa Brennan	Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN1998-1683
First Received:	December 14, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00411892
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Pioglitazone

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00411892