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

Primary Purpose

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

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
inhaled human insulin
insulin aspart
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

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

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

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections

Secondary Outcome Measures

Patient Reported Outcomes
Diabetes control measured by change in HbA1c from baseline
Preprandial Insulin Doses

Full Information

First Posted
May 11, 2007
Last Updated
February 28, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00472953
Brief Title
Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)
Acronym
iINHALE 8
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description
Study Start Date
May 15, 2007 (Actual)
Primary Completion Date
March 5, 2008 (Actual)
Study Completion Date
March 5, 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 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).
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, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (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)
inhaled human insulin
Intervention Description
Treat-to-target dose titration scheme, pre-prandial, inhalation.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Treat-to-target dose titration scheme, pre-prandial, injection s.c.
Primary Outcome Measure Information:
Title
To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections
Time Frame
After one year
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes
Time Frame
After one year
Title
Diabetes control measured by change in HbA1c from baseline
Time Frame
After one year
Title
Preprandial Insulin Doses
Time Frame
After one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Buenos Aires
ZIP/Postal Code
B1636DSU
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
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
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
020992
Country
Romania
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
Facility Name
Novo Nordisk Investigational Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Chiayi City
ZIP/Postal Code
600
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
231
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Gaziantep
ZIP/Postal Code
27070
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34400
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

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

Learn more about this trial

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

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