Effect of Inhaled Pre-Prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes - Full Text View

Purpose

This trial is conducted in the United States of America (USA).

This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin or rosiglitazone treatment, both in combination with metformin and glimepiride.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: rosiglitazone Drug: inhaled human insulin Drug: metformin Drug: glimepiride	Phase III

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Dextrose Glimepiride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Fasting plasma glucose [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Lipid profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Glucose profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment:	225
Study Start Date:	January 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation. Drug: metformin Tablets, 2000 mg/day. Drug: glimepiride Tablets, 8 mg/day.
B: Active Comparator	Drug: rosiglitazone Tablets, 4 mg once or twice daily. Drug: metformin Tablets, 2000 mg/day. Drug: glimepiride Tablets, 8 mg/day.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes
Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
BMI less than or equal to 40 kg/m2

Exclusion Criteria:

Current smoking or smoking within the last 6 months
Current acute or chronic pulmonary disease (except for asthma)
Proliferative retinopathy requiring acute treatment
Clinically significant disease history including kidney or liver disease
Heart disease which limits physical activity or results in discomfort with physical activity
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427154

Show 22 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Yizhen Xu, M.D., Ph.D.	Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN1998-1540
First Received:	January 25, 2007
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00427154
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glimepiride

Metabolic Diseases

Metformin

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Rosiglitazone

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Immunologic Factors

Therapeutic Uses

Physiological Effects of Drugs

Cardiovascular Agents

Anti-Arrhythmia Agents

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00427154