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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)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00322257
First received: May 3, 2006
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  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
Diabetes Mellitus, Type 1
 Drug: inhaled human insulin
Drug: insulin detemir
Drug: insulin aspart
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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: 596
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
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.

  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

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

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00322257     History of Changes
Other Study ID Numbers: NN1998-2076
Study First Received: May 3, 2006
Last Updated: July 9, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2012