Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00322257

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: inhaled human insulin Drug: insulin detemir Drug: insulin aspart	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: After 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body weight [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
Antibodies [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
Hypoglycemia [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Insulin doses [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Pulmonary Function [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Fasting plasma glucose [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	597
Study Start Date:	May 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation. Drug: insulin detemir Injection s.c., 50% of daily dose
B: Active Comparator	Drug: insulin detemir Injection s.c., 50% of daily dose Drug: insulin aspart Treat-to-target dose titration scheme, injection s.c.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322257

Show 82 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Gabriele Sonnenberg

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:	NN1998-2076
Study First Received:	May 3, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00322257
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009