NCT00331604|TerminatedPhase 3

Study Stopped

See termination reason in detailed description

Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN1998-21612005-005378-58

Study Type

interventional

Target

618

Locations

11 countries

Sites

Timeline

RegisteredMay 2006

StartedAug 2006

CompletionMay 2008

Brief Summary

This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

Trial Health

Monitor

Trial Health Score

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

Enrollment

618

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Aug 2006

Typical duration for phase_3 diabetes

Geographic Reach

11 countries

73 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

1.7 years study duration

First Submitted

Initial submission to the registry

May 24, 2006

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed

3 months until next milestone

Study Start

First participant enrolled

August 31, 2006

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2008

Completed

Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

May 24, 2006

Last Update Submit

February 28, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Treatment difference in HbA1c
After 52 weeks

Secondary Outcomes (5)

Adverse events
For the duration of the trial
Blood glucose
After 52, 104 and 116 weeks of treatment
Body weight
During treatment
Lung function
After 52, 104 and 116 weeks of treatment
Hypoglycaemia
From 12 weeks of treatment

Study Arms (3)

A

EXPERIMENTAL

Drug: inhaled human insulinDrug: insulin detemir

B

ACTIVE COMPARATOR

Drug: insulin detemirDrug: insulin aspart

C

ACTIVE COMPARATOR

Drug: insulin detemirDrug: insulin aspart

Interventions

inhaled human insulinDRUG

Treat-to-target dose titration scheme, inhalation.

insulin detemirDRUG

Injection s.c., 50% of daily dose.

Also known as: NN304, Levemir

ABC

insulin aspartDRUG

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

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Currently treated with insulin
Body mass index of (BMI) less than or equal to 40.0 kg/m2
HbA1c less than or equal to 11.0%

You may not qualify if:

Total daily insulin dosage less than or equal to 100 IU or U/day
Current smoking or smoking within the last 6 months
Cardiac problems
Uncontrolled hypertension
Current proliferative retinopathy or maculopathy

Contact the study team to confirm eligibility.