NCT00725036|CompletedPhase 3

Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes

A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN1998-1496

Study Type

interventional

Target

305

Locations

1 country

Sites

Timeline

RegisteredJul 2008

StartedSep 2002

CompletionDec 2004

Brief Summary

This trial is conducted in Oceania. The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

305

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Sep 2002

Longer than P75 for phase_3 diabetes

Geographic Reach

1 country

18 active sites

Status

completed

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

2.3 years study duration

Study Start

First participant enrolled

September 2, 2002

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2004

Completed

3.6 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed

Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

2.3 years

First QC Date

July 29, 2008

Last Update Submit

February 28, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Long term pulmonary safety profiles
during treatment

Secondary Outcomes (6)

Glycaemic control as measured by HbA1c
Incidence of hypoglycaemic episodes
Long-term safety profiles (laboratory, ECG, insulin antibodies)
Physical examination and body weight and vital signs
Adverse events
+1 more secondary outcomes

Interventions

inhaled human insulinDRUG

insulin aspartDRUG

insulin NPHDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 1 diabetes
Current treatment with any insulin in any regimen
Body mass index (BMI) below 38.0 kg/m2
HbA1c below or equal to 13.0%

You may not qualify if:

Total daily insulin dosage more than 100 IU/day
Current acute or chronic pulmonary disease (excluding asthma)
Recurrent major hypoglycaemia
Proliferative retinopathy or maculopathy requiring acute treatment
Smoker
Chest X-ray with clinically significant abnormalities

Contact the study team to confirm eligibility.