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

Sponsor:	Novo Nordisk
Information provided by (Responsible Party):	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00427154

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 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Insulin human Glimepiride Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

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:	227
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
Active Comparator: A	Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation. Other Name: NN1998 Drug: metformin Tablets, 2000 mg/day. Drug: glimepiride Tablets, 8 mg/day.
Active Comparator: B	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 80 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Yizhen Xu, M.D., Ph.D.

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00427154 History of Changes
Other Study ID Numbers:	NN1998-1540
Study First Received:	January 25, 2007
Last Updated:	September 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Rosiglitazone
Insulin
Metformin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012