Inhaled Technosphere Insulin Compared with Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial  

Oleh:

Bode, Bruce W. ; McGill, Janet B. ; Lorber, Daniel L. ; Gross, Jorge L. ; P.-C. Chang ; Bregman, David B.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Diabetes Care vol. 38 no. 12 (Dec. 2015), page 2266-2273.
Topik: Technosphere Insulin
Fulltext: D05 v38 n12 p2266 kelik2016.pdf (1.2MB)

Ketersediaan

Perpustakaan FK Nomor Panggil: D05.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

OBJECTIVE To compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS This open-label noninferiority trial compared the change in HbA1c from baseline to week 24 of prandial TI (n = 174) with that of subcutaneous aspart (n = 171), both with basal insulin, in patients with type 1 diabetes and HbA1c 7.5–10.0% (56.8–86.0 mmol/mol). RESULTS Mean change in HbA1c in TI patients (–0.21% [–2.3 mmol/mol]) from baseline (7.94% [63.3 mmol/mol]) was noninferior to that in aspart patients (–0.40% [–4.4 mmol/mol]) from baseline (7.92% [63.1 mmol/mol]). The between-group difference was 0.19% (2.1 mmol/mol) (95% CI 0.02–0.36), satisfying the noninferiority margin of 0.4%. However, more aspart patients achieved HbA1c <7.0% (53.0 mmol/mol) (30.7% vs. 18.3%). TI patients had a small weight loss (–0.4 kg) compared with a gain (+0.9 kg) for aspart patients (P = 0.0102). TI patients had a lower hypoglycemia event rate than aspart patients (9.8 vs. 14.0 events/patient-month, P < 0.0001). Cough (generally mild) was the most frequent adverse event (31.6% with TI, 2.3% with aspart), leading to discontinuation in 5.7% of patients. Treatment group difference for mean change from baseline in forced expiratory volume in 1 s was small (40 mL) and disappeared upon TI discontinuation. CONCLUSIONS In patients with type 1 diabetes receiving basal insulin, HbA1c reduction with TI was noninferior to that of aspart, with less hypoglycemia and less weight gain but increased incidence of cough.

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