Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00331604
First received: May 24, 2006
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
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 Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 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:
  • Treatment difference in HbA1c [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Blood glucose [ Time Frame: after 52, 104 and 116 weeks of treatment ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Lung function [ Time Frame: after 52, 104 and 116 weeks of treatment ] [ Designated as safety issue: No ]
  • Hypoglycaemia [ Time Frame: from 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 618
Study Start Date: August 2006
Study Completion Date: May 2008
Primary Completion Date: May 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 Names:
  • NN304
  • Levemir
Active Comparator: B Drug: insulin detemir
Injection s.c., 50% of daily dose.
Other Names:
  • NN304
  • Levemir
Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c.
Active Comparator: C Drug: insulin detemir
Injection s.c., 50% of daily dose.
Other Names:
  • NN304
  • Levemir
Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c.
Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c. After 2 years.

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 2 diabetes
  • Currently treated with insulin
  • Body mass index of (BMI) less than or equal to 40.0 kg/m2
  • HbA1c less than or equal to 11.0%

Exclusion Criteria:

  • Total daily insulin dosage less than or equal to 100 IU or U/day
  • Current smoking or smoking within the last 6 months
  • Cardiac problems
  • Uncontrolled hypertension
  • Current proliferative retinopathy or maculopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331604

Locations
Brazil
São Paulo - SP - Brazil, Brazil
Denmark
AArhus, Denmark
France
Narbonne, France
Germany
Völklingen, Germany
Hong Kong
Shatin, New Territories, Hong Kong, Hong Kong
Israel
Jerusalem, Israel
Italy
Pisa, Italy
Singapore
Singapore, Singapore
Spain
Almeria, Spain
Taiwan
Taipei, Taiwan
United Kingdom
Salford, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Trine Dano Klingberg Novo Nordisk A/S
Study Director: Lisbeth Bonefeld Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00331604     History of Changes
Other Study ID Numbers: NN1998-2161, 2005-005378-58
Study First Received: May 24, 2006
Last Updated: July 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Taiwan: Department of Health
Spain: Spanish Agency of Medicines
Singapore: Health Sciences Authority
United Kingdom: Medicines and Healthcare Products Regulatory
Denmark: Danish Medicines Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
Brazil: National Health Surveillance Agency
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014