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Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma (iINHALE 9)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin aspart
inhaled human insulin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • Treatment with insulin and/or oral anti-diabetic drugs
  • Asthma for at least 6 months
  • Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
  • HbA1C less than or equal to 11.0 %
  • Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

  • Current smoking or smoking within the last 6 months
  • Other current acute or chronic pulmonary disease excluding asthma
  • Recurrent severe hypoglycaemia
  • Proliferative retinopathy or maculopathy

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Changes in lung function, chest X-rays, or asthma exacerbation frequency

Secondary Outcome Measures

Diabetes control measured by change in HbA1c
Laboratory assessments (biochemistry, insulin antibodies, blood count)
Preprandial insulin doses

Full Information

First Posted
August 29, 2007
Last Updated
September 3, 2018
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00523042
Brief Title
Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma
Acronym
iINHALE 9
Official Title
Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description
Study Start Date
August 30, 2007 (Actual)
Primary Completion Date
February 28, 2008 (Actual)
Study Completion Date
February 28, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Europe, Asia, Oceania and the United States of America (USA). This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Other Intervention Name(s)
NovoRapid®, NovoLog®
Intervention Description
Treat-to-target dose titration scheme, injection s.c.
Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Intervention Description
Treat-to-target dose titration scheme, inhalation.
Primary Outcome Measure Information:
Title
Changes in lung function, chest X-rays, or asthma exacerbation frequency
Time Frame
after 52 weeks of treatment
Secondary Outcome Measure Information:
Title
Diabetes control measured by change in HbA1c
Time Frame
from baseline to end of treatment
Title
Laboratory assessments (biochemistry, insulin antibodies, blood count)
Time Frame
from baseline to end of treatment
Title
Preprandial insulin doses
Time Frame
for the duration of the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 or type 2 diabetes Treatment with insulin and/or oral anti-diabetic drugs Asthma for at least 6 months Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years HbA1C less than or equal to 11.0 % Body Mass Index (BMI) less than or equal to 40.0 kg/m2 Exclusion Criteria: Current smoking or smoking within the last 6 months Other current acute or chronic pulmonary disease excluding asthma Recurrent severe hypoglycaemia Proliferative retinopathy or maculopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Keswick
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
East Ringwood
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Kippa Ring
ZIP/Postal Code
4021
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
ZIP/Postal Code
600034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
ZIP/Postal Code
400 067
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
ZIP/Postal Code
411011
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Cheras
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu, Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
04190
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Lubochna
ZIP/Postal Code
03491
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Moldava nad Bodvou
ZIP/Postal Code
045 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Zilina
ZIP/Postal Code
01207
Country
Slovakia

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma

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