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

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ClinicalTrials.gov Identifier: NCT00469586
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : May 4, 2007
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: inhaled human insulin Drug: metformin 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes
Actual Study Start Date : April 26, 2007
Primary Completion Date : April 24, 2008
Study Completion Date : April 24, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. HbA1c change from baseline [ Time Frame: After 18 weeks of treatment ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: For the duration of the trial ]
  2. Body weight [ Time Frame: after 18 weeks of treatment ]
  3. Lung function [ Time Frame: after 18 weeks of treatment ]
  4. Blood glucose [ Time Frame: after 18 weeks of treatment ]
  5. Hypoglycaemia [ Time Frame: after 18 weeks of treatment ]

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

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

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): NCT00469586

  Show 59 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00469586     History of Changes
Other Study ID Numbers: NN1998-1787
2006-004623-12 ( EudraCT Number )
First Posted: May 4, 2007    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
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors