Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD) (iINHALE 8)

Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, Parallel Trial to Investigate Long-term Safety

This trial is conducted in Europe, Asia and South America. A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2; Diabetes; Diabetes Mellitus, Type 1; Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: inhaled human insulin; Drug: insulin aspart

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
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1636DSU
    • Novo Nordisk Investigational Site
  • Buenos Aires, Argentina, C1425AGC
    • Novo Nordisk Investigational Site
  • Ciudad de Buenos Aires, Argentina, 1280
    • Novo Nordisk Investigational Site
• India
  • Hyderabad, India, 600034
    • Novo Nordisk Investigational Site
  • Mumbai, India, 400 067
    • Novo Nordisk Investigational Site
  • Pune, India, 411011
    • Novo Nordisk Investigational Site
  • Punjab
    • Chandigarh, Punjab, India, 160012
      • Novo Nordisk Investigational Site
  • Tamil Nadu
    • Vellore, Tamil Nadu, India, 632004
      • Novo Nordisk Investigational Site
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Novo Nordisk Investigational Site
• Romania
  • Bucharest, Romania, 020475
    • Novo Nordisk Investigational Site
  • Bucharest, Romania, 020992
    • Novo Nordisk Investigational Site
• Slovakia
  • Kosice, Slovakia, 04190
    • Novo Nordisk Investigational Site
  • Lubochna, Slovakia, 03491
    • Novo Nordisk Investigational Site
  • Moldava nad Bodvou, Slovakia, 045 01
    • Novo Nordisk Investigational Site
  • Zilina, Slovakia, 01001
    • Novo Nordisk Investigational Site
  • Zilina, Slovakia, 01207
    • Novo Nordisk Investigational Site
• Taiwan
  • Changhua, Taiwan, 500
    • Novo Nordisk Investigational Site
  • Chiayi City, Taiwan, 600
    • Novo Nordisk Investigational Site
  • Taipei, Taiwan, 231
    • Novo Nordisk Investigational Site
• Thailand
  • Bangkok, Thailand, 10330
    • Novo Nordisk Investigational Site
  • Bangkok, Thailand, 10700
    • Novo Nordisk Investigational Site
• Turkey
  • Erzurum, Turkey, 25240
    • Novo Nordisk Investigational Site
  • Gaziantep, Turkey, 27070
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34722
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34400
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34890
    • Novo Nordisk Investigational Site
  • Kocaeli, Turkey, 41380
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic Obstructive Pulmonary Disease
• Type 1 or type 2 diabetes
• HbA1c lower or equal to 11.0 %
• Body Mass Index (BMI) lower or equal to 40.0 kg/m2

Exclusion Criteria:

• Recurrent severe hypoglycaemia
• Current smoking or smoking within the last 6 months
• Other pulmonary disease including asthma
• Proliferative retinopathy or maculopathy requiring acute treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: insulin aspart; Treat-to-target dose titration scheme, pre-prandial, injection s.c.
Experimental: A	Drug: inhaled human insulin; Treat-to-target dose titration scheme, pre-prandial, inhalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections	After one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Reported Outcomes	After one year
Diabetes control measured by change in HbA1c from baseline	After one year
Preprandial Insulin Doses	After one year

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2007
• Primary Completion (Actual): March 5, 2008
• Study Completion (Actual): March 5, 2008

Study Registration Dates

• First Submitted: May 11, 2007
• First Submitted That Met QC Criteria: May 11, 2007
• First Posted (Estimate): May 14, 2007

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart
• Other Study ID Numbers: NN1998-1617; 2006-004731-29 (EudraCT Number)