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Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

NCT ID: NCT00343980

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-10

Study Completion Date

2008-03-10

Brief Summary

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This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)

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Detailed Description

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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.

Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

inhaled human insulin

Intervention Type DRUG

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

glimepiride

Intervention Type DRUG

Tablets, 4 mg/day.

B

Group Type ACTIVE_COMPARATOR

rosiglitazone

Intervention Type DRUG

Tablets, 4 mg once or twice a day.

glimepiride

Intervention Type DRUG

Tablets, 4 mg/day.

Interventions

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rosiglitazone

Tablets, 4 mg once or twice a day.

Intervention Type DRUG

inhaled human insulin

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

Intervention Type DRUG

glimepiride

Tablets, 4 mg/day.

Intervention Type DRUG

Other Intervention Names

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NN1998

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Treated with OAD(s) for more than or equal to 2 months
* Body mass index (BMI) less than or equal to 40.0 kg/m2
* HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
* HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy

Exclusion Criteria

* Recurrent major hypoglycaemia
* Current smoking or smoking within the last 6 months
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* Proliferative retinopathy or maculopathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

St Leonards, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

Wollongong, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

Garran, , Australia

Site Status

Novo Nordisk Investigational Site

Kingswood, , Australia

Site Status

Novo Nordisk Investigational Site

Osijek, , Croatia

Site Status

Novo Nordisk Investigational Site

Zagreb, , Croatia

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Vellore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Bangalore, , India

Site Status

Novo Nordisk Investigational Site

Chennai, , India

Site Status

Novo Nordisk Investigational Site

Coimbatore, , India

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Cebu City, , Philippines

Site Status

Novo Nordisk Investigational Site

Makati City, , Philippines

Site Status

Novo Nordisk Investigational Site

Manila, , Philippines

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Bornova-IZMIR, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Bursa, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Australia Croatia India North Macedonia Philippines Russia Turkey (Türkiye)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN1998-1682

Identifier Type: -

Identifier Source: org_study_id

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