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I nhaled insulin (INH, Exubera) is under investigation for preprandial treatment of patients with type 1 and type 2 diabetes (1–3). This dry-powder insulin formulation is delivered by aerosol, permitting the noninvasive administration of rapid-acting insulin (4). Preliminary studies have shown that INH provides reproducible and effective control of glycemia(More)
OBJECTIVE To examine the effect of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on the major components of renal glucose reabsorption (decreased maximum renal glucose reabsorptive capacity [TmG], increased splay, and reduced threshold), using the pancreatic/stepped hyperglycemic clamp (SHC) technique. RESEARCH DESIGN AND METHODS(More)
OBJECTIVE To compare the pharmacokinetics and glucodynamics of three rapid-acting insulin analogs (aspart, glulisine, and lispro) injected subcutaneously with or without recombinant human hyaluronidase (rHuPH20). RESEARCH DESIGN AND METHODS This double-blind six-way crossover euglycemic glucose clamp study was conducted in 14 healthy volunteers. Each(More)
AIMS/HYPOTHESIS This study evaluates the pharmacodynamic and pharmacokinetic properties of the novel ultra-fast insulin product VIAject, a formulation of human soluble insulin and generally recognised as safe ingredients designed to increase the rate of absorption. METHODS We performed five euglycaemic glucose clamps (Biostator; target blood glucose 5(More)
INTRODUCTION This randomized, double-blind, placebo-controlled, single and multiple ascending-dose study evaluated the pharmacodynamic effects and safety/tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes. METHODS Patients (N = 116) discontinued their antihyperglycemic medications 2 weeks before(More)
OBJECTIVE To compare the pharmacokinetics, pharmacodynamics, and safety of insulin lispro or regular human insulin (RHI) with or without recombinant human hyaluronidase (rHuPH20) administered before a standardized meal. RESEARCH DESIGN AND METHODS In this four-way, crossover study, 22 patients with type 1 diabetes received injections of individually(More)
OBJECTIVE Human regular U-500 (U-500R) insulin (500 units/mL) is increasingly being used clinically, yet its pharmacokinetics (PK) and pharmacodynamics (PD) have not been well studied. Therefore, we compared PK and PD of clinically relevant doses of U-500R with the same doses of human regular U-100 (U-100R) insulin (100 units/mL). RESEARCH DESIGN AND(More)
Remogliflozin etabonate (RE) is the prodrug of remogliflozin, a selective inhibitor of the renal sodium-dependent glucose transporter 2 (SGLT2), which could increase urine glucose excretion (UGE) and lower plasma glucose in humans. This double-blind, randomized, placebo-controlled, single-dose, dose-escalation, crossover study is the first human trial(More)
Biosimilar insulins are approved copies of insulins outside patent protection. Advantages may include greater market competition and potential cost reduction, but clinicians and users lack a clear perspective on 'biosimilarity' for insulins. The manufacturing processes for biosimilar insulins are manufacturer-specific and, although these are reviewed by(More)
In 2008, the US Food and Drug Administration (FDA) issued guidance requiring demonstration of cardiovascular safety for all new glucose-lowering agents intended for the treatment of type 2 diabetes. The main driver for this move was the negative experience that the FDA had encountered with rosiglitazone. This widely prescribed thiazolidinedione had come(More)