Exenatide bid observational study (ExOS): baseline population characteristics of a prospective research study to evaluate the clinical effectiveness of exenatide bid use in patients with type 2 diabetes in a real-world setting

Abstract

Objectives:

To describe the Exenatide Observational Study (ExOS) and patients initiating exenatide therapy in a real-world clinical practice setting.     

Exenatide BID Observational Study (ExOS): results for primary and secondary endpoints of a prospective research study to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes in a real-world setting

Abstract

Objective:

The Exenatide BID Observational Study (ExOS) was designed to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes (T2D) in a real-world clinical practice setting in the United States.     

Real-world comparative outcomes of US type 2 diabetes patients initiating analog basal insulin therapy

Abstract

Objective:

To evaluate outcomes in insulin-naive patients with type 2 diabetes mellitus (T2DM) who initiated insulin glargine or insulin detemir.     

A prospective study to optimize insulin treatment by switching to insulin glargine in type 2 diabetic patients previously uncontrolled on premixed insulin: the optimization study

Abstract

Objective:

To evaluate the efficacy, safety and treatment satisfaction of insulin glargine plus oral antidiabetic drugs (OADs) in Chinese individuals with Type 2 diabetes inadequately controlled with premixed insulin plus OADs.     

Treat-to-target comparison between once daily biphasic insulin aspart 30 and insulin glargine in Chinese and Japanese insulin-naïve subjects with type 2 diabetes

Abstract

Objective:

To investigate whether once daily biphasic insulin aspart 30 (BIAsp 30) is noninferior to once daily insulin glargine (IGlar) among Chinese and Japanese insulin-naïve subjects with type 2 diabetes mellitus (T2DM).     

A pooled analysis of exenatide use and risk of acute pancreatitis

Abstract

Objective:

To estimate the association between exenatide BID use and acute pancreatitis across two claims-based studies.     

Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label,multinational RCT

Abstract

Objectives:

To assess the efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) and insulin glargine, administered once daily in subjects with type 2 diabetes inadequately controlled with oral anti-diabetic drugs.     

GLP-1 receptor agonists and HBA1c target of <7% in type 2 diabetes: meta-analysis of randomized controlled trials

Abstract

Objective:

Glucagon-like peptide-1 (GLP-1) receptor agonists are available for the treatment of type 2 diabetes. We assessed the efficacy of exenatide and liraglutide to reach the HbA_1c target of <7% in people with type 2 diabetes.     

Comparison of daily insulin dose and other antidiabetic medications usage for type 2 diabetes patients treated with an analog basal insulin

Abstract

Objective:

Few comparisons of real-world insulin detemir (DET) and insulin glargine (GLAR) utilization have been conducted, which would assist payers and other healthcare decision makers assess the cost effectiveness of these treatment alternatives. The aim of this study was to compare the amount of insulin utilized in a large cohort of patients with type 2 diabetes treated with either DET or GLAR in the real-world setting considering the use of other antidiabetic agents.     

Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes

Abstract

Objective:

The primary aim was to evaluate duration of action of a single 0.8?U/kg dose of insulin lispro protamine suspension (ILPS) in type 2 diabetes (T2DM) patients; secondarily to compare onset and duration of action of ILPS, glargine (G), and detemir (D) (0.8?U/kg) and evaluate pharmacokinetic (PK) and pharmacodynamic (PD) dose responses of ILPS.     

Early use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in Type 2 diabetes

Abstract

Objective:

To evaluate the efficacy and safety of the available glucagon-like peptide-1 receptor agonists (GLP-1 RAs) exenatide and liraglutide (marketed as Byetta and Victoza, respectively) in first- or second-line pharmacotherapy for type 2 diabetes (T2D), described here as ‘early use’.     

Long-Acting Phospholipid Gel of Exenatide for Long-Term Therapy of Type II Diabetes

Purpose

This study aimed to develop a sustained-release formulation of exenatide (EXT) for the long-term therapeutic efficacy in the treatment of type II diabetes.

Methods

In this study, we present an injectable phospholipid gel by mixing biocompatible phospholipid S100, medium chain triglyceride (MCT) with 85% (w/w) ethanol. A systemic pre-formulation study has been carried out to improve the stability of EXT during formulation fabrication. With the optimized formulation, the pharmacokinetic profiles in rats were studied and two diabetic animal models were employed to evaluate the therapeutic effect of EXT phospholipid gel via a single subcutaneous injection versus repeated injections of normal saline and EXT solution.

Results

With optimized formulation, sustained release of exenatide in vivo for over three consecutive weeks was observed after one single subcutaneous injection. Moreover, the pharmacodynamic study in two diabetic models justified that the gel formulation displayed a comparable hypoglycemic effect and controlled blood glucose level compared with exenatide solution treated group.

Conclusions

EXT-loaded phospholipid gel represents a promising controlled release system for long-term therapy of type II diabetes.

     

Protected Graft Copolymer (PGC) Basal Formulation of Insulin as Potentially Safer Alternative to Lantus® (Insulin-Glargine): A Streptozotocin-Induced,Diabetic Sprague Dawley Rats Study

Purpose

To develop a long-acting formulation of native human insulin with a similar pharmacodynamics (PD) profile as the insulin analogue insulin glargine (Lantus®, Sanofi-Aventis) with the expectation of retaining native human insulin’s superior safety profile as insulin glargine is able to activate the insulin-like growth factor 1 (IGF-1) receptor and is linked to a number of malignancies at a higher rate than regular human insulin.

Methods

Development of protected graft copolymer (PGC) excipients that bind native human insulin non-covalently and testing blood glucose control obtained with these formulations in streptozotocin-induced diabetic Sprague Dawley rats compared to equally dosed insulin glargine.

Results

PGC-formulations of native human insulin are able to control blood glucose to the same extent and for the same amount of time after s.c. injection as the insulin analogue insulin glargine. No biochemical changes were made to the insulin that would change receptor binding and activation with their possible negative effects on the safety of the insulin.

Conclusion

Formulation with the PGC excipient offers a viable alternative to biochemically changing insulin or other receptor binding peptides to improve PD properties.

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Figure Blood glucose development in STZ-diabetic Sprague Dawley rats after s.c. injection of 1 mg/kg regular human insulin formulated with formulations 605c, 421a, and 421b, or an equivalent dose of insulin glargine.

     

Surgical resection of subependymal giant cell astrocytomas (SEGAs) and changes in SEGA-related conditions: a US national claims database study

Abstract

Objectives:

To compare the prevalence rates of clinical conditions related to subependymal giant cell astrocytomas (SEGAs) before and after SEGA surgery among patients with tuberous sclerosis complex (TSC).     

Clinical and economic outcomes associated with community-acquired intra-abdominal infections caused by extended spectrum beta-lactamase (ESBL) producing bacteria in China

Abstract

Background:

To compare clinical and economic outcomes in patients with community-acquired intra-abdominal infection (IAI) due to extended spectrum beta-lactamase (ESBL) producing (ESBL-positive) bacteria versus non-ESBL-producing (ESBL-negative) bacteria in China.     

Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results

Abstract

Objective:

To investigate the safety and efficacy of switching to biphasic insulin aspart (BIAsp) 30, 50 or 70 in patients with type 2 diabetes previously treated with biphasic human insulin (BHI) 30/50 (with or without oral glucose-lowering drugs) in routine clinical practice.     

Colesevelam in the treatment of hypercholesterolemia and hyperglycemia: a retrospective analysis from an ambulatory care medical network

Abstract

Objective:

To examine outcomes associated with colesevelam treatment among patients with hypercholesterolemia in real-world clinical practice.     

Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain

Abstract

Background and objectives:

Breakthrough cancer pain (BTcP) represents an important clinical challenge in the care of patients with cancer. This trial evaluated the efficacy and long-term tolerability of a sublingual formulation of the fast-acting opioid fentanyl, for the treatment of BTcP in opioid-tolerant patients with cancer.     

Efficacy,safety, and tolerability of mometasone furoate in adult Japanese patients with mild asthma: open-label clinical trial findings

Abstract

Objective:

To evaluate the clinical efficacy and safety of mometasone furoate administered via a dry powder inhaler (MF-DPI) in Japanese patients with intermittent or mild persistent asthma who were not previously receiving inhaled corticosteroids.     

Current practice of darbepoetin alfa in the management of haemoglobin levels in cancer patients undergoing chemotherapy – data from the CHOICE study

Abstract

Objective:

To evaluate adherence to European Organisation for Research and Treatment of Cancer (EORTC) and European Summary of Product Characteristic (SmPC) guidance on recommended haemoglobin (Hb) values in routine clinical practice use of darbepoetin alfa (DA) in cancer patients internationally.