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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):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE June 22, 2006
First Posted Date  ICMJE June 23, 2006
Last Update Posted Date March 1, 2017
Actual Study Start Date  ICMJE October 10, 2006
Actual Primary Completion Date March 10, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2007)
Treatment difference in HbA1c [ Time Frame: After 26 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2006)
Treatment difference in HbA1c after 26 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2006)
  • Blood glucose
  • Hypoglycaemia
  • Body weight
  • Lung function
  • Adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
Official Title  ICMJE Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes
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)
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: rosiglitazone
    Tablets, 4 mg once or twice a day.
  • Drug: inhaled human insulin
    Treat-to-target dose titration scheme, pre-prandial, inhalation.
    Other Name: NN1998
  • Drug: glimepiride
    Tablets, 4 mg/day.
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: inhaled human insulin
    • Drug: glimepiride
  • Active Comparator: B
    Interventions:
    • Drug: rosiglitazone
    • Drug: glimepiride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 7, 2009)
363
Original Enrollment  ICMJE
 (submitted: June 22, 2006)
345
Actual Study Completion Date  ICMJE March 10, 2008
Actual Primary Completion Date March 10, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Croatia,   India,   Macedonia, The Former Yugoslav Republic of,   Philippines,   Russian Federation,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00343980
Other Study ID Numbers  ICMJE NN1998-1682
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP