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Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

This study has been terminated.
(See termination reason in detailed description)
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: May 3, 2006
Last updated: February 28, 2017
Last verified: February 2017
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 Diabetes Mellitus, Type 1 Drug: inhaled human insulin Drug: insulin detemir Drug: insulin aspart Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • HbA1c [ Time Frame: After 52 weeks ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: after 52 weeks ]
  • Antibodies [ Time Frame: after 52 weeks ]
  • Hypoglycemia [ Time Frame: For the duration of the trial ]
  • Insulin doses [ Time Frame: For the duration of the trial ]
  • Pulmonary Function [ Time Frame: For the duration of the trial ]
  • Fasting plasma glucose [ Time Frame: after 52 weeks ]

Enrollment: 596
Actual Study Start Date: May 1, 2006
Study Completion Date: April 2, 2008
Primary Completion Date: April 2, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Drug: insulin detemir
Injection s.c., 50% of daily dose
Other Name: Levemir, NN304
Active Comparator: B Drug: insulin detemir
Injection s.c., 50% of daily dose
Other Name: Levemir, NN304
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00322257

  Show 96 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00322257     History of Changes
Other Study ID Numbers: NN1998-2076
Study First Received: May 3, 2006
Last Updated: February 28, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin Aspart
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 16, 2017