MD Conference Express EASD 2012 - (Page 17)
treated with diet and exercise alone, or with a stable dose of metformin (≥1000 mg/day for ≥3 months prior to screening) were eligible. Key exclusion criteria were related to hepatic diseases. Subjects (mean age 50 years, mean diabetes duration between 3 and 5 years) were randomly assigned to LY 10 mg (n=17), 30 mg (n=34), 60 mg (n=26), or placebo (n=10) QD for 12 weeks. There were 52.9% to 58.8% of the LY patients taking metformin versus 70% of placebo subjects. Mean baseline HbA1C was highest in the LY 10-mg group (8%) and 7.5%, 7.6%, and 7.8% in the 30-mg, 60-mg, and placebo groups, respectively. At Week 12, HbA1C change from baseline showed that LY was associated with significant (p≤0.05) dose-dependent improvements in glycemic control in contrast to placebo (Figure 1). LY also produced dose-dependent increases in fasting glucagon, alanine aminotransferase, aspartate aminotransferase, and total GLP-1 that returned to baseline after LY washout. The proportions of patients who experienced any treatment-emergent adverse event (TEAE) were similar in all treatment groups. No severe TEAEs were reported. Two non-drug-related serious adverse events occurred. There were no severe hypoglycemia events and 4 confirmed (blood glucose measurements) hypoglycemia events. Incidence of hypoglycemia was not dose dependent. There were no significant changes from baseline observed in any of the 3 LY treatment groups compared with placebo for body weight, blood pressure, triglycerides, low-density lipoprotein and high-density lipoprotein cholesterol, bilirubin, fasting insulin, or active GLP-1.
12Week Treatment with LY2409021 Significantly
Treatment with LY resulted in dose-dependent transient increases in mean aminotransferase, fasting glucagon, and total GLP-1 levels without elevated bilirubin or other signs/ symptoms of liver injury. There were no increases in body weight, lipids, or blood pressure. The efficacy, safety, and tolerability profile of LY in patients with T2DM supports further clinical development.
The editors would like to thank the many members of the EASD Congress 2012 presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.
Figure 1. miTT Population: Mean Change from Baseline in HbA1C at Week 12.
1.0 0.5 0 -0.5 -1.0 -1.5
Placebo
10 mg 30 mg 60 mg
LS Mean (90% Cl) Change from Baseline in HbA1C
** **
Treatment Groups
**
**Change from baseline versus placebo at indicated time points (p≤0.05; MMRM analysis)
LS=least squares; miTT=modified intention-to-treat; MMRM=Mixed Model Repeated Measures. Reproduced with permission from CM Kazda, MD.
Peer-Reviewed Highlights of the 48th Annual Meeting of the European Association for the Study of Diabetes
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Table of Contents for the Digital Edition of MD Conference Express EASD 2012
MD Conference Express EASD 2012
Contents
Understanding Incretin Hormone Action and the Treatment of Diabetes
New ADA/EASD Guidelines Focus on Patient-Centered Care
ORIGIN Trial: Insulin Glargine and n-3 Fatty Acids Fail to Reduce CV Events in Diabetic Patients
Exenatide Once Weekly Sustained Improvement in Glycemic Control with Weight Loss Through 4 Years
DiaPep277® Shows Promise as a Therapeutic Strategy for T1DM
Linagliptin Proves Safe and Effective as Add-on Therapy to Basal Insulin
12-Week Treatment with LY2409021 Significantly Lowers HbA1C and Is Well Tolerated in Patients with T2DM
Insulin Degludec Is Superior to Sitagliptin in Improving Glycemic Control in Uncontrolled Patients with Type 2 Diabetes on Oral Agents
Dapagliflozin Does Not Impact Renal Function in Patients with T2DM
Population-Based Screening for T2DM:The ADDITION-Cambridge Trial
The Challenges of Pharmaceutical Management of Painful Diabetic Peripheral Neuropathy
Enterovirus Infection
Novel Oral Agents
GLP-1
Genetics
Renal Denervation
Hypertension and Renal Function Are Risk Factors for CAD in T1DM
MD Conference Express EASD 2012
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