NCT00472953|TerminatedPhase 3

Study Stopped

See termination reason in detailed description

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN1998-16172006-004731-29

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredMay 2007

StartedMay 2007

CompletionMar 2008

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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started May 2007

Shorter than P25 for phase_3 diabetes

Geographic Reach

7 countries

27 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

May 11, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed

1 day until next milestone

Study Start

First participant enrolled

May 15, 2007

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2008

Completed

Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

May 11, 2007

Last Update Submit

February 28, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections
After one year

Secondary Outcomes (3)

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

Study Arms (2)

A

EXPERIMENTAL

Drug: inhaled human insulin

B

ACTIVE COMPARATOR

Drug: insulin aspart

Interventions

inhaled human insulinDRUG

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

insulin aspartDRUG

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

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.