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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: rosiglitazone (Drug); inhaled human insulin (Drug); metformin (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Yizhen Xu, M.D., Ph.D., Study Director, Affiliation: Novo Nordisk

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in HbA1c

Secondary outcome:

Fasting plasma glucose

Lipid profiles

Hypoglycaemic episodes

Glucose profiles

Change in body weight

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Novo Nordisk Clinical Trial Call Center, Santa Barbara, California 93105, United States

Novo Nordisk Clinical Trial Call Center, Escondido, California 92026, United States

Novo Nordisk Clinical Trial Call Center, Concord, California 94520, United States

Novo Nordisk Clinical Trial Call Center, San Diego, California 92128, United States

Novo Nordisk Clinical Trial Call Center, Fresno, California 93720, United States

Novo Nordisk Clinical Trial Call Center, Colorado Springs, Colorado 80904, United States

Novo Nordisk Clinical Trial Call Center, Waterbury, Connecticut 06708, United States

Novo Nordisk Clinical Trial Call Center, Merritt Island, Florida 32953, United States

Novo Nordisk Clinical Trial Call Center, Hollywood, Florida 33021, United States

Novo Nordisk Clinical Trial Call Center, Winter Park, Florida 32789, United States

Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30309, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60607, United States

Novo Nordisk Clinical Trial Call Center, Peoria, Illinois 61615, United States

Novo Nordisk Clinical Trial Call Center, Des Moines, Iowa 50314, United States

Novo Nordisk Clinical Trial Call Center, Topeka, Kansas 66606, United States

Novo Nordisk Clinical Trial Call Center, St. Louis, Missouri 63141, United States

Novo Nordisk Clinical Trial Call Center, Omaha, Nebraska 68131, United States

Novo Nordisk Clinical Trial Call Center, Lawrenceville, New Jersey 08648, United States

Novo Nordisk Clinical Trial Call Center, Asheville, North Carolina 28801, United States

Novo Nordisk Clinical Trial Call Center, Medford, Oregon 97504, United States

Novo Nordisk Clinical Trial Call Center, Chattanooga, Tennessee 37403, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78229, United States

Clinical Trials at Novo Nordisk

Starting date: January 2007
Ending date: January 2008
Last updated: January 30, 2008