Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00308737
• Date of registration: 28/03/2006
• Prospective Registration: No
• Primary sponsor: Mannkind Corporation
• Public title: Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
• Scientific title: Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.
• Date of first enrolment: June 2005
• Target sample size: 2053
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00308737
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, Czech Republic, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes, Type 1

Diabetes, Type 2

Intervention(s)

Drug: Usual Care

Drug: Technosphere® Insulin Inhalation Powder

Primary Outcome(s)

Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care [Time Frame: Baseline to Month 24]

FEV1 Decrease of = 15% From Baseline Value at Last Measurement for TI vs Usual Care [Time Frame: Baseline to Month 24]

Secondary Outcome(s)

Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM [Time Frame: Baseline to Month 24]

Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care [Time Frame: Baseline to Month 24]

Change in Weight From Baseline at Month 24 [Time Frame: Baseline to Month 24]

Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement [Time Frame: Baseline to Month 24]

Total Lung Capacity (TLC) Decrease of = 15% From Baseline Value at Last Measurement [Time Frame: Baseline to Month 24]

Forced Vital Capacity (FVC) Decrease of = 15% From Baseline Value at Last Measurement [Time Frame: Baseline to Month 24]

Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of = 15% From Baseline Value at Last Measurement [Time Frame: Baseline to Month 24]

Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care [Time Frame: Baseline to Month 24]

Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM [Time Frame: Baseline to Month 24]

Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM [Time Frame: Baseline to Month 24]

Secondary ID(s)

MKC-TI-030

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/10/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00308737