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

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

Sponsors

Lead sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Terminated
Start Date May 15, 2007
Completion Date March 5, 2008
Primary Completion Date March 5, 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections After one year
Secondary 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
Enrollment 38
Condition
Intervention

Intervention type: Drug

Intervention name: inhaled human insulin

Description: Treat-to-target dose titration scheme, pre-prandial, inhalation.

Arm group label: A

Intervention type: Drug

Intervention name: insulin aspart

Description: Treat-to-target dose titration scheme, pre-prandial, injection s.c.

Arm group label: B

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

Gender: All

Minimum age: 30 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
facility
Novo Nordisk Investigational Site | Buenos Aires, B1636DSU, Argentina
Novo Nordisk Investigational Site | Buenos Aires, C1425AGC, Argentina
Novo Nordisk Investigational Site | Ciudad de Buenos Aires, 1280, Argentina
Novo Nordisk Investigational Site | Chandigarh, Punjab, 160012, India
Novo Nordisk Investigational Site | Vellore, Tamil Nadu, 632004, India
Novo Nordisk Investigational Site | Kolkata, West Bengal, 700020, India
Novo Nordisk Investigational Site | Hyderabad, 600034, India
Novo Nordisk Investigational Site | Mumbai, 400 067, India
Novo Nordisk Investigational Site | Pune, 411011, India
Novo Nordisk Investigational Site | Bucharest, 020475, Romania
Novo Nordisk Investigational Site | Bucharest, 020992, Romania
Novo Nordisk Investigational Site | Kosice, 04190, Slovakia
Novo Nordisk Investigational Site | Lubochna, 03491, Slovakia
Novo Nordisk Investigational Site | Moldava nad Bodvou, 045 01, Slovakia
Novo Nordisk Investigational Site | Zilina, 01001, Slovakia
Novo Nordisk Investigational Site | Zilina, 01207, Slovakia
Novo Nordisk Investigational Site | Changhua, 500, Taiwan
Novo Nordisk Investigational Site | Chiayi City, 600, Taiwan
Novo Nordisk Investigational Site | Taipei, 231, Taiwan
Novo Nordisk Investigational Site | Bangkok, 10330, Thailand
Novo Nordisk Investigational Site | Bangkok, 10700, Thailand
Novo Nordisk Investigational Site | Erzurum, 25240, Turkey
Novo Nordisk Investigational Site | Gaziantep, 27070, Turkey
Novo Nordisk Investigational Site | Istanbul, 34400, Turkey
Novo Nordisk Investigational Site | Istanbul, 34722, Turkey
Novo Nordisk Investigational Site | Istanbul, 34890, Turkey
Novo Nordisk Investigational Site | Kocaeli, 41380, Turkey
Location Countries

Argentina

India

Romania

Slovakia

Taiwan

Thailand

Turkey

Verification Date

February 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A

Arm group type: Experimental

Arm group label: B

Arm group type: Active Comparator

Acronym iINHALE 8
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov