Liza L. Ilag

Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study)

To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in combination with oral antihyperglycaemic medications in patients with type 2 diabetes (T2D).

Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study.

To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in patients with type 1 diabetes (T1D).

Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus

To compare the immunogenicity profiles and the potential effects on clinical outcomes of LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar), products with identical primary amino acid sequences, in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM).

Does A1c consistently reflect mean plasma glucose

Background:  A1c, a surrogate measure of glycemic control, is known to have a strong linear correlation with mean plasma glucose (MPG) when analyzed in populations of patients. However, clinically significant intersubject variability in this relationship exists, which suggests that A1c measurements may not reflect actual glycemic control in some patients. In the present study we explored the extent to which A1c accurately represents glycemic control, as measured by MPG, for individual patients.

Comparison of insulin lispro protamine suspension and insulin detemir in basal-bolus therapy in patients with Type 1 diabetes.

Diabet. Med. 27, 563–569 (2010)

Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine

The safety and efficacy of LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar), products with identical primary amino acid sequences, were assessed in subgroups of patients with type 1 (T1D, n = 452) or type 2 diabetes (T2D, n = 299) reporting prestudy IGlar treatment in 52‐week open‐label (ELEMENT‐1) and 24‐week double‐blind (ELEMENT‐2) studies. At randomization, patients transitioned from their prestudy IGlar to equivalent doses of LY IGlar or IGlar. Primary efficacy (change in glycated haemoglobin from baseline to 24 weeks), other efficacy and select safety outcomes of LY IGlar were compared with those of IGlar. Continuous data were analysed using analysis of covariance, categorical data by Fishers exact test, and treatment comparisons for hypoglycaemia by Wilcoxon test. No statistically significant treatment differences were identified for efficacy and safety outcomes except for weight change (T1D), overall incidence of detectable insulin antibodies (T2D), and serious adverse events (T2D). These differences were neither consistently observed across both studies nor observed in the total study populations, and their magnitude suggests they were not clinically meaningful. LY IGlar and IGlar show similar efficacy and safety profiles in patients reporting prestudy IGlar treatment.

The relationship between self-monitored blood glucose values and glycated haemoglobin in insulin-treated patients with Type 2 diabetes

Diabet. Med. 27, 589–592 (2010)

Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy

Self‐efficacy plays a critical role in diabetes self‐care. Herein we explore factors contributing to decreased insulin therapy self‐efficacy in insulin‐naïve patients with type 2 diabetes mellitus (T2DM) initiating and managing insulin therapy over 36 weeks.

Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy (2型糖尿病患者经过36周的胰岛素治疗后，患者对胰岛素治疗的期望、感知的胰岛素给药装置的社会接受性以及对胰岛素治疗的满意度都可以导致胰岛素治疗自我效能感的下降)†

Self‐efficacy plays a critical role in diabetes self‐care. Herein we explore factors contributing to decreased insulin therapy self‐efficacy in insulin‐naïve patients with type 2 diabetes mellitus (T2DM) initiating and managing insulin therapy over 36 weeks.

Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus® Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation

IntroductionLY2963016 insulin glargine (LY IGlar) and Lantus® (IGlar), both with identical primary amino acid sequences, were compared in two phase 3 studies for intrapatient blood glucose variability.MethodsELEMENT-1 was a 52-week study in patients with type 1 diabetes (T1D), which included Japanese patients, and ELEMENT-2 was a 24-week study in non-Japanese patients with type 2 diabetes (T2D). In ELEMENT-1, 535 patients with T1D were evaluable (268 LY IGlar and 267 IGlar). Of these, 100 were Japanese patients (49 LY IGlar and 51 IGlar). In ELEMENT-2, 756 patients with T2D were evaluable (376 LY IGlar and 380 IGlar). We evaluated and compared intrapatient blood glucose variability of LY IGlar and IGlar in these studies from three different perspectives: intrapatient between-day fasting blood glucose variability, intrapatient between-day daily mean blood glucose variability, and intrapatient within-day blood glucose variability.ResultsOverall, evaluations of all three indices showed that intrapatient blood glucose variability was similar between LY IGlar and IGlar throughout the study periods both in the overall populations of patients with T1D and T2D and also in the subgroup of Japanese patients with T1D.ConclusionIntrapatient blood glucose variability between LY IGlar and IGlar was shown to be similar in patients with T1D or T2D.Clinical Trial RegistrationNCT01421147 (ELEMENT-1) and NCT01421459 (ELEMENT-2).FundingEli Lilly and Company (Indianapolis, IN, USA); Boehringer-Ingelheim (Ridgefield, CT, USA); Eli Lilly Japan K.K. (Kobe, Japan) and Nippon Boehringer Ingelheim Co., Ltd. (Tokyo, Japan).