Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial

Rosenstock, Julio; Lorber, Daniel; Gnudi, Luigi; Howard, Craig D.; Bilheimer, David W.; Chang, P. C.; Petrucci, Richard; Boss, Anders H.; Richardson, Peter

doi:10.1016/s0140-6736(10)60632-0

Cited by 113 publications

(109 citation statements)

References 24 publications

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“…Cough resulting in withdrawal from the study was uncommon; in cases where subjects discontinued owing to cough, notably, cough resolved within 24-48 h after cessation of the dry powder inhalation. The incidence of cough, 23.7% in the TI group and 19.9% in the TP group, was similar to what has been reported with other inhaled insulins (32)(33)(34).…”

Section: Discussionsupporting

confidence: 86%

“…Less hypoglycemia risk is one of the main reasons basal insulin is the preferred initial treatment, in addition to the obvious preference of once-daily injection instead of multiple prandial injections (10,11,24). A previous trial in subjects with T2D, comparing TI plus insulin glargine with twice-daily biaspart insulin, demonstrated lower rates of hypoglycemia, especially delayed hypoglycemia (2-4 h after the dose), and less weight gain in TI-treated subjects (32), probably due to the shorter duration of action of TI. Predictably, in this placebo-controlled trial, the incidence of hypoglycemia was higher in the insulin-treated subjects than the inhaled placebo group.…”

Section: Discussionmentioning

confidence: 99%

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Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents

Rosenstock

Franco²,

Корпачев

et al. 2015

Diabetes Care

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OBJECTIVETo investigate the efficacy and safety of prandial Technosphere inhaled insulin (TI), an inhaled insulin with a distinct time action profile, in insulin-naïve type 2 diabetes (T2D) inadequately controlled on oral antidiabetes agents (OADs). RESEARCH DESIGN AND METHODSSubjects with T2D with HbA 1c levels ‡7.5% (58.5 mmol/mol) and £10.0% (86.0 mmol/mol) on metformin alone or two or more OADs were randomized to add-on prandial TI (n = 177) or prandial Technosphere inhaled placebo (TP) (n = 176) to their OAD regimen in this double-blind, placebo-controlled trial. Primary end point was change in HbA 1c at 24 weeks. RESULTSTI significantly reduced HbA 1c by 20.8% (29.0 mmol/mol) from a baseline of 8.3% (66.8 mmol/mol) compared with TP 20.4% (24.6 mmol/mol) (treatment difference 20.4% [95% CI 20.57, 20.23]; P < 0.0001). More TI-treated subjects achieved an HbA 1c £7.0% (53.0 mmol/mol) (38% vs. 19%; P = 0.0005). Mean fasting plasma glucose was similarly reduced in both groups. Postprandial hyperglycemia, based on 7-point glucose profiles, was effectively controlled by TI. Mean weight change was 0.5 kg for TI and 21.1 kg for the TP group (P < 0.0001). Mild, transient dry cough was the most common adverse event, occurring similarly in both groups (TI, 23.7%; TP, 19.9%) and led to discontinuation in only 1.1% of TI-treated and 3.4% of TP-treated subjects. There was a small decline in forced expiratory volume in 1 s in both groups, with a slightly larger decline in the group receiving TI (TI, 20.13 L; TP, 20.04 L). The difference resolved after treatment discontinuation. CONCLUSIONSPrandial TI added to one or more OADs in inadequately controlled T2D is an effective treatment option. Mild, transient dry cough was the most common adverse event.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents

Rosenstock

Franco²,

Корпачев

et al. 2015

Diabetes Care

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“…It is a rapid-acting insulin, taken before meals, and appears effective in lowering glucose levels in patients with T1D and T2D. 24 A cough seems to be a minor adverse effect but longer term effects on the respiratory system have not been excluded.…”

Section: Inhaled and Oral Insulinmentioning

confidence: 99%

Drug therapies in type 2 diabetes: an era of personalised medicine

Chowdhury

Grant

2016

Clinical Medicine

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Optimal management of diabetes involves a multidisciplinary approach. Prioritisation of lifestyle change, blood pressure and lipid control, and regular screening for complications are advocated in most international guidelines. Good glucose control, however, remains an important aim of treatment, although it is increasingly recognised that glucose targets should be individualised, with less stringent targets for older patients with significant comorbidities.In recent years, a number of newer therapies for hyperglycaemia have become available. This review aims to discuss currently available options for patients with type 2 diabetes, and also discusses potential new therapies that may be on the horizon in the future.

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“…In those with T2D, insulin naïve patients treated with inhaled insulin gained more weight than those continuing on oral agents [40]. However, in studies comparing prandial inhaled insulin to short-acting subcutaneous insulin, there was either no change or less weight gain in those randomized to inhaled insulin [39, 47,48]. The unique safety issue of inhaled insulin compared to other insulin formulations is related to potential effects on lung function.…”

Section: Safety Of Inhaled Insulinmentioning

confidence: 99%

Managing diabetes with inhaled insulin

Mastrandrea

2012

RHC

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The incidence of diabetes is increasing world-wide. Many individuals with diabetes require insulin to control their blood sugar and prevent both microvascular and macrovascular complications associated with this chronic disease. Current regimens involve delivery of subcutaneous insulin by injection or continuous insulin infusion. One area of research to advance diabetes care is aimed at developing alternate routes of insulin administration that will make daily management less invasive for patients. This review will focus on inhaled insulin, a novel formulation which takes advantage of drug delivery through the pulmonary system. The pharmacology, efficacy, and safety of inhaled insulin will be discussed. In addition, the status of inhaled insulin as a potential therapy for individuals with diabetes will be reviewed.

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Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial

Cited by 113 publications

References 24 publications

Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents

Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents

Drug therapies in type 2 diabetes: an era of personalised medicine

Managing diabetes with inhaled insulin

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