MD Conference Express EASD 2012 - (Page 14)
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function and insulin sensitivity were indicated by increases in the Homeostasis Model Assessment for β-cell function (HOMA-B; 26%±6%) and for insulin sensitivity (HOMA-S; 13%±3%). These changes from baseline were observed at Year 1 and maintained thereafter.
EASD 2012 Exenatide Sustained Improvement in Figure 1.Once Weekly Resulted inthrough 4Associated with Once-Weekly Exenatide Years Glycemic Control with Weight Loss
Improved HbA1Cwith Improved A1C and FPGGlucose Through Fig1 EQW Associated and Fasting Plasma Through 4 y 4 Years.
8.5 4-y Completers (n=176) 8.0
Improvements (baseline to 4 years) were also observed for cardiovascular risk markers: systolic BP (–1.6 mm Hg; -8.7 mm Hg in patients with abnormal baseline systolic BP), diastolic BP (–2.7 mm Hg), total cholesterol (–0.30 mmol/L), low-density lipoprotein cholesterol (–0.20 mmol/L), high-density lipoprotein cholesterol (+0.05 mmol/L), and triglycerides (–13%). Maximum response was seen at Year 2 and maintained thereafter. Seventy-one percent of patients lost weight (–2.5 kg mean weight loss at Year 4). Nausea and injection-site pruritus—the most common adverse events (AEs)—decreased in incidence with ongoing therapy, as did vomiting and diarrhea. The annual event rate for nausea and injection-site pruritus was 15/100 years and 6/100 years patient exposure over the 4-year study duration. Cardiac and renal/urinary disorders occurred at event rates of 5 and 6 per 100 years patient exposure, respectively. Twenty percent of EQW patients experienced serious AEs (no identifiable pattern of types of events) and 3 patients died (none due to treatment). Withdrawal rates over the 4-year duration due to AEs were low (8%); gastrointestinal AEs led to withdrawal in few (2%) patients. There was no major hypoglycemia. Minor hypoglycemia increased minimally after 1 year of exenatide therapy. There were few minor hypoglycemia events in patients not using concomitant sulfonylurea. Long-term exenatide treatment was associated with significant, sustained improvement in glycemic control and improvements in cardiometabolic measures, with no unexpected safety findings.
HbA1C (%)
7.5 7.0 6.5 6.0
HbA1C at Year 4: 6.9%
Baseline
Year 1
Year 2
Year 3
Year 4
10 9 8 7
FPG (mmol/L)
FPG at Year 4: 7.3 mmol/L
6
Baseline
Year 1
Year 2
Year 3
Year 4
% Achieving HbA1C Target
100 80 60 40 20 0
55% 36%
DiaPep277® Shows Promise as a Therapeutic Strategy for Type 1 Diabetes
Written by Maria Vinall
<7.0%
≤6.5%
• Improvements in β-cell function and insulin sensitivity at 4 years:
-HOMA-B 26%±6% -HOMA-S 13%±3%
Administration of DiaPep277® is safe and represents a promising therapeutic strategy in patients with recentonset type 1 diabetes (T1DM). Results of two large Phase 3 trials will determine if this therapy might change the current approach to treating newly diagnosed T1DM patients [Tuccinardi D et al. Expert Opin Biol Ther 2011]. Itamar Raz, MD, Hadassah Medical Center, Jerusalem, Israel, reported outcomes from 1 of these trials—a multinational, randomized, double-blind, placebocontrolled, parallel-group study to investigate the clinical Efficacy and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients [DIA-AID 1; NCT00615264].
FPG=fasting plasma glucose; HOMA-B=Homeostasis Model Assessment B-cell function; HOMA-S=Homeostasis Model Assessment, insulin sensitivity; SE=standard error. Reproduced with permission from Amylin Pharmaceuticals.
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November 2012
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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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