Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes (iINHALE 7)

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00469586
First received: May 3, 2007
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: inhaled human insulin
Drug: metformin
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: Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: After 18 weeks of treatment ] [ 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: after 18 weeks of treatment ] [ Designated as safety issue: No ]
  • Lung function [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]
  • Blood glucose [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]
  • Hypoglycaemia [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: April 2007
Study Completion Date: April 2008
Primary Completion Date: April 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
Experimental: B Drug: inhaled human insulin
Treat-to-target dose titration scheme, post-prandial, inhalation.
Other Name: NN1998
Active Comparator: C Drug: metformin
Tablets, 2000 mg/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 OADs for more than or equal to 3 months
  • HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
  • Body Mass Index (BMI) less than or equal to 40.0 kg/m2

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: NCT00469586

Locations
Argentina
Buenos Aires, Argentina
Austria
Vienna, Austria
Belgium
Leuven, Belgium
Bulgaria
Sofia, Bulgaria
Canada
Edmonton, Canada
France
Narbonne, France
India
Hyderabad, India
Israel
Beer Sheva, Israel
Mexico
Mexico City, Mexico
Poland
Gdansk, Poland
Turkey
Istanbul, Turkey
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Dorthe Lyngsoe Vuylsteke Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00469586     History of Changes
Other Study ID Numbers: NN1998-1787, 2006-004623-12
Study First Received: May 3, 2007
Last Updated: July 9, 2012
Health Authority: Mexico: Federal Commission for Protection Against Health Risks
Turkey: Ministry of Health Drug and Pharmaceutical Department
Canada: Health Canada
India: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Israel: Israeli Health Ministry Pharmaceutical Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
France: Agence du Médicament
Poland: National Medicines Institute
Belgium: FPS of Public Health, Directorate General for the protection of Public Health: Medicines

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

ClinicalTrials.gov processed this record on October 20, 2014