Phase 3
N=2,053
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Diabetes, Type 1 · Diabetes, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00308737 ↗Enrolled (actual)
2,053
Serious AEs
9.2%
Results posted
Oct 2014
Primary outcome: Primary: Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care — -0.16; -0.12 liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Technosphere® Insulin Inhalation Powder (Drug); Usual Care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mannkind Corporation
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care |
-0.16; -0.12 | — |
| PRIMARY FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care |
42; 27 | — |
| SECONDARY Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care |
-0.128; -0.092 | — |
| SECONDARY Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM |
-0.14; -0.11; -0.09 | — |
| SECONDARY Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM |
-0.05; -0.07; -0.02 | — |
| SECONDARY Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM |
-1.60; -1.36; -1.33 | — |
| SECONDARY Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement |
23; 17; 2 | — |
| SECONDARY Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement |
7; 6; 1 | — |
| SECONDARY Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement |
105; 108; 20 | — |
| SECONDARY Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement |
181; 181; 40 | — |
| SECONDARY Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care |
-0.42; -0.49 | — |
| SECONDARY Change in Weight From Baseline at Month 24 |
1.0; 1.64; 1.19 | 0.112 |
Summary
Pulmonary Safety in Diabetics with T/I
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00308737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.