Place of technosphere inhaled insulin in treatment of diabetes

Table 1 Clinical trials of technosphere insulin using Gen2 device

Ref.	Rosenstock et al[9]	Bode et al[10]
Design	Randomized, double-blind, placebo-controlled, 24 wk-duration	Randomized, open-label, 24 wk-duration
Type of diabetes	Type 2	Type 1
Intervention	TI (n = 177) vs placebo (n = 177), both groups were on oral agents	TI (n = 174) vs prandial aspart (n = 170). Both groups received basal insulin (NPH or detemir, or glargine)
Mean HbA1c levels at baseline	8.26%	7.93%
Reduction in HbA1c vs baseline	-0.8% with TI and -0.4% with placebo	-0.21% with TI vs -0.4% with aspart
Reduction in mean HbA1c with TI vs comparator	-0.4% vs placebo (95%CI: -0.57 to -0.23)	0.19% vs aspart (95%CI: 0.02 to 0.36)
Proportions of patients reaching HbA1c ≤ 7%	38% with TI vs 19% with placebo (P = 0.0005)	18% with TI vs 31% with aspart (P = 0.01)
Proportions reporting adverse effects	61% TI vs 51.1% placebo	58% TI vs 43% aspart
Proportions of patients reporting hypoglycemia	67.8% TI vs 30.7% placebo (P < 0.0001)	96% TI vs 99.4% aspart (P = 0.06)
Proportions of patients reporting cough	23.7% TI vs 19.9% placebo (difference not statistically significant)	31.6% TI vs 2.3% aspart P < 0.05
Withdrawal due to cough	1.1% with TI vs 3.4% with placebo	5.7% with TI vs 0% with aspart
Change in mean weight	+ 0.5 kg TI vs -1.1 kg placebo (P < 0.0001)	-0.4 kg with TI vs +0.9 kg aspart (P = 0.01)
Change in mean FEV1 (L)	- 013 L with TI vs -0.04 L with placebo	-0.07 L with TI vs -0.04 L with aspart
Withdrawal due to adverse effects	4% with TI vs with 5.1% placebo	9.2% with TI vs with 0% aspart

FEV1: Forced expiratory volume in 1 s; TI: Technosphere insulin; HbA1c: Hemoglobin A1c.