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Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 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.
ClinicalTrials.gov Identifier: NCT00343980
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : June 23, 2006
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: rosiglitazone Drug: inhaled human insulin Drug: glimepiride 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : October 10, 2006
Primary Completion Date : March 10, 2008
Study Completion Date : March 10, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Treatment difference in HbA1c [ Time Frame: After 26 weeks ]

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00343980


Locations
Australia, New South Wales
Novo Nordisk Investigational Site
St Leonards, New South Wales, Australia, 2065
Novo Nordisk Investigational Site
Wollongong, New South Wales, Australia, 2500
Australia
Novo Nordisk Investigational Site
Garran, Australia, 2605
Novo Nordisk Investigational Site
Kingswood, Australia, 2747
Croatia
Novo Nordisk Investigational Site
Osijek, Croatia, 31 000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
India
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India, 632004
Novo Nordisk Investigational Site
Bangalore, India, 560010
Novo Nordisk Investigational Site
Chennai, India, 600020
Novo Nordisk Investigational Site
Coimbatore, India, 641002
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Philippines
Novo Nordisk Investigational Site
Cebu City, Philippines, 6000
Novo Nordisk Investigational Site
Makati City, Philippines, 1200
Novo Nordisk Investigational Site
Manila, Philippines, 1000
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119034
Novo Nordisk Investigational Site
Moscow, Russian Federation, 121356
Novo Nordisk Investigational Site
Moscow, Russian Federation, 127486
Novo Nordisk Investigational Site
Moscow, Russian Federation, 127644
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194354
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 198013
Turkey
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
Novo Nordisk Investigational Site
Bursa, Turkey, 16059
Novo Nordisk Investigational Site
Istanbul, Turkey, 34098
Novo Nordisk Investigational Site
Istanbul, Turkey, 34390
Novo Nordisk Investigational Site
Istanbul, Turkey, 34718
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00343980     History of Changes
Other Study ID Numbers: NN1998-1682
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glimepiride
Rosiglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors