Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

This study has been terminated.

(See termination reason in detailed description)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00411892

First Posted: December 15, 2006

Last Update Posted: March 1, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novo Nordisk A/S

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 Diabetes Mellitus, Type 2	Drug: pioglitazone Drug: inhaled human insulin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human Pioglitazone

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

HbA1c change from baseline [ Time Frame: After 26 weeks of treatment ]

Secondary Outcome Measures:

Fasting plasma glucose [ Time Frame: after 26 weeks of treatment ]
Lipid profiles [ Time Frame: after 26 weeks of treatment ]
Frequency of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ]
Glucose profiles [ Time Frame: at pre- and post meals, bedtime and 3:00 am ]
Change in body weight [ Time Frame: after 26 weeks of treatment ]


Enrollment:	196
Actual Study Start Date:	November 29, 2006
Study Completion Date:	March 18, 2008
Primary Completion Date:	March 18, 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: pioglitazone Tablets, 45 mg/day. Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation. Other Name: NN1998
Active Comparator: B	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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411892

Show 110 Study Locations

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

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


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00411892 History of Changes
Other Study ID Numbers:	NN1998-1683
First Submitted:	December 14, 2006
First Posted:	December 15, 2006
Last Update Posted:	March 1, 2017
Last Verified:	February 2017

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Insulin, Globin Zinc Pioglitazone Insulin Hypoglycemic Agents Physiological Effects of Drugs

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