Table 1 Summary of clinical and related trials of inhaled insulin

1–2 inhalations per dose

Inhaled insulin

70 (type 1)

HbA_1c (%): 8.51 (INH), 8.53 (SC)

Pulmonary functions: no changes

Acceptance/preference of INH: ≥ 80%.

1–2 inhalations per dose

Inhaled insulin

51 (type 1)

HbA_1c (%): 8.7 (INH), 7.8 (SC)

Pulmonary functions: no changes

Acceptance/preference of INH: 92%

250 U and 500 U

AERx DMS

11 (volunteers)

T_max (min): 7 and 16 for INH 250 and 500 U, respectively

C_max (μU/ml): 29.7 and 23.8 for INH 250 and 500 U, respectively

tG_max (min): 66 and 76 for INH 250 and 500 U, respectively

4–6 inhalations per dose

Inhaled insulin

16 (type 2)

Baseline glucose change: 100 to 53 mg/dl (INH);

100 to 57 mg/dl (SC)

Pulmonary functions: no change

Reproducibility: INH similar to SC

1–2 inhalations per dose

AERx DMS

20 (type 1)

Glucose change from baseline (mg/dl): 82 (60 min), 79 (120 min) and –11 (300 min) for AERx DMS;

89 (60 min), 82 (120 min) and –25 (300 min) for SC

Deleterious effect: none

1–2 inhalations per dose

Inhaled insulin

69 (type 2)

Baseline HbA_1c (%) before therapy: 9.92 (oral agent alone); 9.78 (oral agent + INH)

Change in HbA_1c (%) after 2 weeks: –0.13 (oral agent alone); 2.28 (oral agent + INH)

100 U TI

MedTone inhaler (TI)

12 (type 2)

GIR_max (mg/kg per min): 5.8 (INH), 2.2 (SC)

(PDC)

GIRt_max (min) = 55 (INH), 276 (SC)

USA

Early tGIR50% (min): 17 (INH), 122 (SC)

Late tGIR50% (min): 128 (INH), 335 (SC)

Not mentioned

Inhaled insulin

70 (type 1)

Preference of INH over SC: 81%

Switch from SC to INH: 79%

Continuance of SC: 21%

Satisfaction: 38% (INH), 14% (SC)

Convenience/ease of use: 46% (INH), 12% (SC)

Not mentioned

Inhaled insulin

Number not stated

HbA_1c (%): 8.9 (baseline), 8.0 (after 3 months), 8.1 (after 12 months), 8.0 (after 18 months), 8.0 (after 24 months)

(type 1 and type 2)

FEV₁ (l): 3.2 (baseline), 3.1 (after 12 months), 3.1 (after 18 months), 3.2 (after 24 months)

DLCO (ml/min per mmHg): 25.6 (baseline), 24.7 (after 12 months), 24.7 (after 18 months), 24.4 (after 24 months)

Not mentioned

Inhaled insulin

56 (type 2)

Mean improvement in patient satisfaction (%): 38 (INH),

14 (SC)

INH preference to SC based on: ease of use, comfort and convenience

0.3–1.8 U/kg

AERx DMS

18 (type 1)

T_max (min): for INH 49, 48, 62 and 65 at doses 0.3, 0.6, 1.2 and 1.8 U/kg, respectively; for SC 119 at dose 0.12 U/kg

GIR_max (mg/kg per min): for INH 1.6, 2.5, 4.7 and 6.5 at doses 0.3, 0.6, 1.2 and 1.8 U/kg, respectively; for SC 3.2 at dose 0.12 U/kg

tGIR_max (min): for INH 94, 136, 157 and 218 at doses 0.3, 0.6, 1.2 and 1.8 U/kg, respectively; for SC 189 at dose 0.12 U/kg

25–100 U

MedTone inhaler (TI)

12 (volunteers)

GIR_max (mg/kg per min): concentration dependent

(PDC)

GIRt_max (min): 47, 52, 56 for TI 25, 50 and 100 U, respectively; 192 for SC

T_max (min): 12, 18, and 21 for TI 25, 50 and 100 U, respectively; for SC 153

Bioavailability (relative to SC for 3 h): 46, 42 and 28% for TI 25, 50 and 100 U, respectively