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

This study has been terminated.

(See termination reason in detailed description)

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00343980

First received: June 22, 2006

Last updated: July 9, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 22, 2006

Last Updated Date

July 9, 2012

Start Date ^ICMJE

October 2006

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment difference in HbA1c [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Treatment difference in HbA1c after 26 weeks

Change History

Complete list of historical versions of study NCT00343980 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Body weight [ Time Frame: during treatment ] [ Designated as safety issue: No ]
Lung function [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Blood glucose [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Hypoglycaemia [ Time Frame: from 12-26 weeks of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Adverse events
body weight
Lung function
Blood glucose
Hypoglycaemia

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes

Brief Summary

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)

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: rosiglitazone
Tablets, 4 mg once or twice a day.
Drug: inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.

Other Name: NN1998
Drug: glimepiride
Tablets, 4 mg/day.

Study Arm (s)

Experimental: A
Interventions:
- Drug: inhaled human insulin
- Drug: glimepiride
Active Comparator: B
Interventions:
- Drug: rosiglitazone
- Drug: glimepiride

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

363

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Croatia, India, Macedonia, The Former Yugoslav Republic of, Philippines, Russian Federation, Turkey

Administrative Information

NCT Number ^ICMJE

NCT00343980

Other Study ID Numbers ^ICMJE

NN1998-1682

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Line Elmoe Glesner

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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