Post by sportsrancho on Jun 3, 2016 16:44:45 GMT -5
JOSEPH BRAIN, NIKHIL AMIN, JOHN STEWART, ELENA NIKONOVA, ROBERT WISE, Boston, MA, Danbury, CT, Laval, QC, Canada, Morristown, NJ, Baltimore, MD
Disclosures
J. Brain: Consultant; Author; Sanofi U.S., MannKind Corporation. N. Amin: Employee; Author; MannKind Corporation. J. Stewart: Employee; Author; Sanofi Canada. Stock/Shareholder; Author; Sanofi Canada. E. Nikonova: Other Relationship; Author; Artech Information Systems, LLC, under contract with Sanofi US, Inc. R. Wise: Consultant; Author; Sanofi U.S., MannKind Corporation.
TI is a novel inhaled rapid-acting insulin (RAI) approved for use in the U.S. This analysis explored the impact of baseline lung function on clinical outcomes and lung function changes in patients with T1D or T2D initiating inhaled TI therapy.
This pooled analyses of 7 studies (duration 6-24 months) included 949 patients with T1D and 1,132 with T2D using TI. Patients were stratified based on baseline percent predicted forced expiratory volume in 1 second (FEV1PP): 70% to <80%, 80% to <90%, 90% to < 100%, and ≥ 100%. Differences among strata were assessed with one-way ANOVA analysis for demographics and regression modeling (MMRM) for FEV1 change.
Patients in the lowest strata were older, and more had T2D than in the higher strata; they also had the lowest baseline FEV1 for T1D. Baseline FEV1 did not differ across strata for T2D (Table). There were no significant differences among the baseline FEV1PP groups for the proportion of patients experiencing hypoglycemia, reporting cough, or reaching A1c < 7.0%, or in A1c at the end of the study (Table). The decline in lung function from baseline to 3 months was small and not significantly different among the groups.
The results show that patients with lower baseline lung function (70-80% of predicted normal at baseline) experienced similar glycemic efficacy, hypoglycemia, and lung function changes after 3 months when compared to those with better baseline lung function.
Clinical outcomes and lung function changes in patients stratified by baseline FEV1PP
FEV1PP P Value
70 to < 80%
(n = 145) 80 to < 90%
(n = 456) 90 to < 100%
(n = 696) ≥ 100%
(n = 784)
Age, years (SD) 51 (13) 48 (13) 46 (14) 49 (14) < 0.0001
Female, n (%) 60 (41.4) 196 (43.0) 332 (47.7) 384 (49.0) 0.1071
Diabetes type
T1D
T2D 54 (37.2)
91 (62.8) 206 (45.2)
250 (54.8) 350 (50.3)
346 (49.7) 339 (43.2)
445 (56.8) 0.0073
End of Study A1c < 7.0%, n (%) 14 (10.8) 64 (15.2) 97 (15.1) 121 (17.0) 0.3228
End of Study A1c, % (SD) 8.30 (1.20) 8.20 (1.30) 8.15 (1.35) 8.06 (1.25) 0.1410
Adverse event, n (%) 112 (77.2) 386 (84.6) 563 (80.9) 601 (76.7) 0.0057
Hypoglycemia, n (%) 51 (35.2) 184 (40.4) 284 (40.8) 302 (38.5) 0.5554
Reporting cough, n (%) 38 (26.2) 137 (30.0) 221 (31.8) 219 (27.9) 0.3291
Baseline FEV1, L (SE)
T1D
T2D 2.73 (0.54)
2.99 (0.68) 3.11 (0.62)
2.47 (0.48) 3.44 (0.63)
2.79 (0.55) 3.83 (0.82)
2.98 (0.62) < 0.0001
< 0.0001
FEV1 change from baseline to 3 months, LS mean, L (SE)
T1D
T2D −0.023 (0.22) −0.059 (0.020) −0037 (0.020) −0.056 (0.012) −0.048 (0.009) −0.078 (0.009) −0.043 (0.009) −0.055 (0.010) 0.7785
0.2243
P values in the Table come from a one-way ANOVA analysis, except for the change in FEV1 from baseline to 3 months, which was analyzed by mixed effect model repeated measurement (MMRM) in baseline FEV1; age, gender, and height were included as covariates.
LS means, least square means.
Disclosures
J. Brain: Consultant; Author; Sanofi U.S., MannKind Corporation. N. Amin: Employee; Author; MannKind Corporation. J. Stewart: Employee; Author; Sanofi Canada. Stock/Shareholder; Author; Sanofi Canada. E. Nikonova: Other Relationship; Author; Artech Information Systems, LLC, under contract with Sanofi US, Inc. R. Wise: Consultant; Author; Sanofi U.S., MannKind Corporation.
TI is a novel inhaled rapid-acting insulin (RAI) approved for use in the U.S. This analysis explored the impact of baseline lung function on clinical outcomes and lung function changes in patients with T1D or T2D initiating inhaled TI therapy.
This pooled analyses of 7 studies (duration 6-24 months) included 949 patients with T1D and 1,132 with T2D using TI. Patients were stratified based on baseline percent predicted forced expiratory volume in 1 second (FEV1PP): 70% to <80%, 80% to <90%, 90% to < 100%, and ≥ 100%. Differences among strata were assessed with one-way ANOVA analysis for demographics and regression modeling (MMRM) for FEV1 change.
Patients in the lowest strata were older, and more had T2D than in the higher strata; they also had the lowest baseline FEV1 for T1D. Baseline FEV1 did not differ across strata for T2D (Table). There were no significant differences among the baseline FEV1PP groups for the proportion of patients experiencing hypoglycemia, reporting cough, or reaching A1c < 7.0%, or in A1c at the end of the study (Table). The decline in lung function from baseline to 3 months was small and not significantly different among the groups.
The results show that patients with lower baseline lung function (70-80% of predicted normal at baseline) experienced similar glycemic efficacy, hypoglycemia, and lung function changes after 3 months when compared to those with better baseline lung function.
Clinical outcomes and lung function changes in patients stratified by baseline FEV1PP
FEV1PP P Value
70 to < 80%
(n = 145) 80 to < 90%
(n = 456) 90 to < 100%
(n = 696) ≥ 100%
(n = 784)
Age, years (SD) 51 (13) 48 (13) 46 (14) 49 (14) < 0.0001
Female, n (%) 60 (41.4) 196 (43.0) 332 (47.7) 384 (49.0) 0.1071
Diabetes type
T1D
T2D 54 (37.2)
91 (62.8) 206 (45.2)
250 (54.8) 350 (50.3)
346 (49.7) 339 (43.2)
445 (56.8) 0.0073
End of Study A1c < 7.0%, n (%) 14 (10.8) 64 (15.2) 97 (15.1) 121 (17.0) 0.3228
End of Study A1c, % (SD) 8.30 (1.20) 8.20 (1.30) 8.15 (1.35) 8.06 (1.25) 0.1410
Adverse event, n (%) 112 (77.2) 386 (84.6) 563 (80.9) 601 (76.7) 0.0057
Hypoglycemia, n (%) 51 (35.2) 184 (40.4) 284 (40.8) 302 (38.5) 0.5554
Reporting cough, n (%) 38 (26.2) 137 (30.0) 221 (31.8) 219 (27.9) 0.3291
Baseline FEV1, L (SE)
T1D
T2D 2.73 (0.54)
2.99 (0.68) 3.11 (0.62)
2.47 (0.48) 3.44 (0.63)
2.79 (0.55) 3.83 (0.82)
2.98 (0.62) < 0.0001
< 0.0001
FEV1 change from baseline to 3 months, LS mean, L (SE)
T1D
T2D −0.023 (0.22) −0.059 (0.020) −0037 (0.020) −0.056 (0.012) −0.048 (0.009) −0.078 (0.009) −0.043 (0.009) −0.055 (0.010) 0.7785
0.2243
P values in the Table come from a one-way ANOVA analysis, except for the change in FEV1 from baseline to 3 months, which was analyzed by mixed effect model repeated measurement (MMRM) in baseline FEV1; age, gender, and height were included as covariates.
LS means, least square means.
