Place of technosphere inhaled insulin in treatment of diabetes

Table 2 Clinical trials of technosphere insulin using the Med-Tone device

Ref.	Raskin et al[14]	Rosensensk et al[12]
Design	Randomized, open label, 2 yr-duration, pulmonary safety trial	Randomized, open-label, 52-wk duration
Type of diabetes	Types 1 and 2	Type 2
Groups of subjects and intervention	TI (n = 938), usual diabetes care (n = 951), control subjects without diabetes (n = 164)	Glargine qhs + prandial TI (n = 334) vs1biaspart insulin bid (n = 343)
Proportions of patients with adverse effects	79% TI vs 71% usual care	84% TI vs 89% biaspart
Mean HbA1c at baseline	8.7%	8.7%
Reduction in HbA1c vs baseline	-0.59% with TI and -0.50% with usual care	-0.68% with TI/glargine vs -0.76% with biaspart
Reduction in HbA1c with TI vs comparator	0.09% (not significant)	0.07% (not significant)
Proportions of patients reporting hypoglycemia	39.5% TI vs 39.1% usual care	48% glargine/TI vs 69% biaspart. OR 0.4 (95%CI: 0.3-0.5)
Proportions of patients reporting cough	27.8% TI vs 4.4% usual care	33% glargine/TI vs 6% biaspart
Withdrawal due to cough	4.7% TI vs 0% usual care	2% glargine/TI vs 0% biaspart
Change in mean weight	Not reported	+ 0.9 kg glargine/TI vs +2.5 kg biaspart. Mean difference 1.6 kg (95%CI: -2.4 to -0.7)
Decline in mean FEV1 (liters)	More decline in TI group vs usual care. Mean difference 0.037 (95%CI: 0.017-0.06)	-0.13 glargine/TI vs -0.09 biaspart (difference not significant)
Withdrawal due to adverse effects	11% TI vs 0.6% usual care	9% glargine/TI vs 4% biaspart

¹Biaspart insulin is pre-mixed insulin composed of 70% insulin protamine suspension + 30% insulin aspart. FEV1: Forced expiratory volume in 1 s; TI: Technosphere insulin; HbA1c: Hemoglobin A1c.