Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Type 1, Diabetes, Type 2

In brief

Pulmonary Safety in Diabetics with T/I

Key facts

Study ID

NCT00308737

Run by

Mannkind Corporation

People needed

2053

Starts

2005-06-01

Expected to finish

2008-10-01

Last updated by the study team

2014-10-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For All Subjects:
• Nonsmoking
• Body mass index <42 kg/m2
• FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
• No abnormalities in screening pulmonary radiology
• For Subjects with diabetes mellitus:
• Type 1 or type 2 diabetes for at least 2 years
• HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %
• For Subjects without abnormalities in glucose control:
• No history of diabetes
• Normal results from a formal glucose tolerance test

You may not qualify if…

• History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
• Significant renal, hepatic, or cardiac disease
• Women who are pregnant, lactating, or planning on becoming pregnant
• Subjects who have participated in studies of other investigational drugs within the previous 3 months
• Evidence of severe complications of diabetes

Where it is running

• Lovelace Scientific Resources — Phoenix, Arizona, United States
• Northwest Medical Center — Phoenix, Arizona, United States
• Arizona Center for Clinical Research — Phoenix, Arizona, United States
• Premiere Pharmaceutical Research LLC — Tempe, Arizona, United States
• Canyon Clinical Research — Tucson, Arizona, United States
• Arizona Research Associates — Tuscon, Arizona, United States
• Private Practice — Burlingame, California, United States
• Saint Agnes Medical Center — Fresno, California, United States
• Valley Research — Fresno, California, United States
• (Private Practice) — Garden Grove, California, United States
• Diabetes/Lipid Management Center — Huntington Beach, California, United States
• Interlink Research Institute — Los Alamitos, California, United States
• Diabetes Care Center — Salinas, California, United States
• San Diego Sports Medicine and Family Health Center — San Diego, California, United States
• Dorothy L & James E Frank Diabetes Research Institute — San Mateo, California, United States
• Sansum Medical Research Institute — Santa Barbara, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Kaiser Permanente — Denver, Colorado, United States
• Denver VA Medical Center — Denver, Colorado, United States
• Alliance Medical Group of Greater Waterbury — Middlebury, Connecticut, United States
• New Britain General Hosptal c?o Betsy Keller — New Britain, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Perimeter Institute for Clinical Research (PICR) — Atlanta, Georgia, United States
• Executive Health and Research Associates Inc — Atlanta, Georgia, United States
• Southwest Health Ltd Research Division — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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