Phase 3
Completed N=287
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
Source: ClinicalTrials.gov NCT00139659 ↗Enrolled (actual)
287
Serious AEs
11.9%
Results posted
May 2010
Primary outcomePrimary: Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1) — -0.070; -0.035 L/yr
Summary
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1) |
-0.070; -0.035 | — |
| PRIMARY Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco) |
-0.776; -0.273 | — |
| PRIMARY Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1) |
2.559; 2.524; -0.066; -0.027; -0.056; -0.031 | — |
| PRIMARY Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) |
23.023; 22.883; -0.574; -0.333; -0.777; -0.481 | — |
| SECONDARY Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) |
2.435; 2.412; -0.057; -0.035; -0.065; -0.034 | — |
| SECONDARY Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) |
23.034; 22.911; -0.749; -0.452; -0.835; -0.456 | — |
| SECONDARY Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1) |
2.449; 2.403; -0.038; -0.028; -0.078; -0.017 | — |
| SECONDARY Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) |
22.836; 22.718; -1.130; -0.663; -1.156; -0.630 | — |
| SECONDARY Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) |
3.355; 3.341; -0.068; -0.046; -0.057; -0.053 | — |
| SECONDARY Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol |
5.487; 5.102; -0.015; 0.347; 0.683; 0.347 | — |
| SECONDARY Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1) |
83.698; 82.833; 81.987; 82.878; 81.655; 81.881 | — |
| SECONDARY Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin |
-0.004; 0.003; -0.008; 0.005; 0.000; 0.013 | — |
| SECONDARY Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1) |
94.402; 94.391; 92.698; 94.190; -1.864; -0.456 | — |
| SECONDARY Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin |
-0.163; -0.184; -0.241; -0.131; -0.139; -0.171 | — |
| SECONDARY Methacholine Challenge |
— | — |
| SECONDARY Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1) |
— | — |
| SECONDARY Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication) |
— | — |
| SECONDARY Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage |
— | — |
| SECONDARY Step Classification of Asthma Severity by Medication Usage |
— | — |
| SECONDARY Mean Weekly Asthma Symptom Scores |
— | — |
| SECONDARY Incidence of Non-severe Asthma Exacerbations |
0.43; 0.41; 0.28; 0.38; 0.22; 0.31 | — |
| SECONDARY Incidence of Severe Asthma Exacerbations |
0.00; 0.00; 0.00; 3.13; 0.00; 9.39 | — |
| SECONDARY Number of Systemic Corticosteroid Rescues |
14; 16 | — |
| SECONDARY Asthma Control as Measured by the Asthma Control Questionnaire© |
1.04; 1.21; 2.50; 2.54; 1.25; 1.40 | — |
| SECONDARY Baseline Dyspnea Index (BDI) |
3.37; 3.36; 2.29; 2.29; 2.49; 2.34 | — |
| SECONDARY Transition Dyspnea Index (TDI): Change in Total Score |
0.36; 0.50; 0.51; 0.47; 0.14; 0.13 | — |
| SECONDARY Glycosylated Hemoglobin (HbA1c) |
7.62; 7.43; 7.22; 6.97; -0.38; -0.43 | — |
| SECONDARY Fasting Plasma Glucose |
149.22; 149.03; 143.02; 136.54; -3.34; -15.19 | — |
| SECONDARY Body Weight: Mean Baseline and Change From Baseline |
87.41; 87.13; -0.02; 1.00; 0.12; 0.57 | — |
| SECONDARY Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight) |
41.70; 45.50; 41.75; 45.46; 43.48; 47.19 | — |
| SECONDARY Total Daily Long-Acting Insulin Dose Adjusted for Body Weight |
0.47; 0.52; 0.47; 0.53; 0.49; 0.52 | — |
| SECONDARY Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) |
30.56; 30.74; 11.03; 29.52; 12.13; 31.24 | — |
| SECONDARY Total Daily Short-Acting Insulin Dose Adjusted for Body Weight |
0.35; 0.36; 0.12; 0.34; 0.14; 0.36 | — |
| SECONDARY Lipids: Median Change From Baseline to Last Observation |
-0.5; 0; 9; -8; -3; 1 | — |
| SECONDARY Hypoglycemic Event Rates |
2.99; 2.48; 2.52; 2.34; 2.12; 1.84 | — |
| SECONDARY Severe Hypoglycemic Event Rates |
2.91; 1.48; 5.22; 1.49; 4.64; 2.99 | — |
Eligibility Criteria
Inclusion Criteria
- Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
- Mild intermittent or mild to moderate persistent asthma
Exclusion Criteria
- Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking
Data sourced from ClinicalTrials.gov (NCT00139659). 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. Informational only — not medical advice.