Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

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. Identifier: NCT00322257
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : May 5, 2006
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: inhaled human insulin Drug: insulin detemir Drug: insulin aspart Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 596 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Study Start Date : May 1, 2006
Primary Completion Date : April 2, 2008
Study Completion Date : April 2, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. Body weight [ Time Frame: after 52 weeks ]
  2. Antibodies [ Time Frame: after 52 weeks ]
  3. Hypoglycemia [ Time Frame: For the duration of the trial ]
  4. Insulin doses [ Time Frame: For the duration of the trial ]
  5. Pulmonary Function [ Time Frame: For the duration of the trial ]
  6. Fasting plasma glucose [ Time Frame: after 52 weeks ]

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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

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 identifier (NCT number): NCT00322257

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00322257     History of Changes
Other Study ID Numbers: NN1998-2076
First Posted: May 5, 2006    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 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