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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 )

First Received on June 22, 2006.   Last Updated on February 22, 2011   History of Changes
Sponsor: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00343980
  Purpose

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 III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia
Drug Information available for: Insulin Insulin beef Glimepiride Rosiglitazone Rosiglitazone Maleate
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Treatment difference in HbA1c [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Lung function [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Blood glucose [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Hypoglycaemia [ Time Frame: from 12-26 weeks of treatment ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343980

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

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00343980     History of Changes
Other Study ID Numbers: NN1998-1682
Study First Received: June 22, 2006
Last Updated: February 22, 2011
Health Authority: Russia: Federal Service for Control of Health Care and Social Development;   Turkey: Ministry of Health Drug and Pharmaceutical Department;   Croatia: Ministry of Health and Social Care;   India: Ministry of Health;   Philippines: Bureau of Food and Drugs;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health

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

ClinicalTrials.gov processed this record on February 09, 2012



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