Safety and Efficacy of Inhaled Pre-prandial Human 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:
NCT00343980
First received: June 22, 2006
Last updated: July 9, 2012
Last verified: July 2012
  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
Diabetes Mellitus, Type 2
Drug: rosiglitazone
Drug: inhaled human insulin
Drug: glimepiride
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: 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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
Investigators
Study Director: Line Elmoe Glesner Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: 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: July 9, 2012
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
Insulin, Globin Zinc
Glimepiride
Rosiglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 22, 2014