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Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

This study has been terminated.
(See termination reason in detailed description)
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: June 22, 2006
Last updated: July 9, 2012
Last verified: July 2012
This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: rosiglitazone
Drug: inhaled human insulin
Drug: glimepiride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes

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 26 weeks ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: For the duration of the trial ]
  • Body weight [ Time Frame: during treatment ]
  • Lung function [ Time Frame: after 26 weeks of treatment ]
  • Blood glucose [ Time Frame: after 26 weeks of treatment ]
  • Hypoglycaemia [ Time Frame: from 12-26 weeks of treatment ]

Enrollment: 363
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
Other Name: NN1998
Drug: glimepiride
Tablets, 4 mg/day.
Active Comparator: B Drug: rosiglitazone
Tablets, 4 mg once or twice a day.
Drug: glimepiride
Tablets, 4 mg/day.

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 2 diabetes
  • Treated with OAD(s) for more than or equal to 2 months
  • Body mass index (BMI) less than or equal to 40.0 kg/m2
  • HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
  • HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy

Exclusion Criteria:

  • Recurrent major hypoglycaemia
  • Current smoking or smoking within the last 6 months
  • Impaired hepatic or renal function
  • Cardiac problems
  • Uncontrolled hypertension
  • Proliferative retinopathy or maculopathy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00343980

Canberra, Australia
Zagreb, Croatia
Royapuram, India
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of
Cebu City, Philippines
Russian Federation
Moscow, Russian Federation
Bursa, Turkey
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Line Elmoe Glesner Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00343980     History of Changes
Other Study ID Numbers: NN1998-1682 
Study First Received: June 22, 2006
Last Updated: July 9, 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors processed this record on February 20, 2017