New NHANES Analysis Shows No Improvement in Last Decade to Get More Diabetes Patients to HbA1c Goal; Separate Study Suggests Reduced Efficacy in Real-World Plays Large Role Due to Adherence Falling Far Short of Clinical Trials

NEW ORLEANS, June 12, 2016 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced a troubling and noteworthy analysis of NHANES published data underscoring an urgent need for innovative strategies to improve patient adherence to achieve and maintain glycemic goals for a vast number of patients with type 2 diabetes. The findings were presented over the past two days at the 76th Scientific Sessions of the American Diabetes Association.

The new NHANES analysis from 2011-2014 showed a slight erosion in the percent of patients at HbA1c goal of <7% since the earlier 2003-2006 report − approximately 50% of patients currently, which is down from 56.8% in the previous report. A second analysis, using a large U.S. integrated EMR-administrative claims database, assessed the HbA1c lowering effect in the real-world setting of two currently available categories of agents: GLP-1s (glucagon-like peptide-1 receptor agonists) and DPP4s (dipeptidyl peptidase 4 inhibitors). Results indicate that treatment efficacy in the real-world falls far short of that demonstrated under controlled clinical trial conditions, most likely due to poor medication adherence with these pill and self-injected medicines.

"Our analysis reveals an alarming disparity between HbA1c reduction seen in short-term controlled clinical trials and what is being achieved over time in real-world settings. This disconnect is primarily driven by poor adherence to current pill and injection therapies," said Steven Edelman, M.D., Professor of Medicine, University of California, San Diego and founder of the patient-focused organization, Taking Control of Your Diabetes. "In fact, only approximately 50 percent of all people with diabetes in this country are achieving HbA1c goal with their current therapies and there has been little change in this statistic over the past decade. This is frankly shocking, eye-opening information that the health care community needs to confront with new and different therapeutic strategies."

Sub-optimal control of HbA1c puts patients at higher risk of complications associated with a progressive and serious disease like type 2 diabetes. Published clinical study results of pills and injections may set unrealistic expectations of benefit that are not reproducible in the majority patients' from a long-term outcomes point of view.  

"Despite over 40 new pills and injections approved for type 2 diabetes in the last decade, there are still more than 50% of patients who continue to have poorly controlled blood sugar levels over time," said Kurt Graves, Chairman, President and CEO of Intarcia. "NHANES data shows that despite dozens of pills and injections recently brought to market, we have yet to turnaround two of the biggest unmet need trends in diabetes; sub-optimal glucose control and patient non-adherence with therapy. As an industry, we must innovate and bring totally new therapeutic approaches and drug delivery systems capable of controlling blood sugar over time and taking the real-world non-adherence challenges off the table. This is Intarcia's primary mission and focus – to finally reverse these trends for patients."

About the NHANES (National Health and Nutrition Examination Survey) Study

Previous research has found that the percentage of U.S. adults with diabetes achieving glycated hemoglobin (HbA1c) goals of <7% with currently available treatments has been fairly constant, remaining at just over 50% (Ali et al. New England Journal of Medicine 2013). The objective of this study was to compare the most recent data (2011-2014) with earlier data to track progress on HbA1c goal <7.0% and individualized goals based on age and the presence of complications (Inzucchi et al. Diabetes Care 2012, 2015).

Data from 2,677 adults 18 and older with self-reported diabetes from NHANES were examined to determine the percentage of adults who achieved HbA1c goals of <7%. HbA1c data were collected from blood samples, while self-reported diabetes diagnoses and complications history was collected from interviews. The percentage of survey participants with diabetes and HbA1c <7.0% slightly declined from earlier NHANES analyses performed for periods 2003-2006 (56.8%) and 2007-2010 (52.2%) to 50.9% (CI: 47.2-54.7%).

About the Real-World vs Randomized Clinical Trial Study

A large U.S. integrated EMR-administrative claims database was used to identify type 2 diabetes patients who initiated a GLP-1RA or DPP4. HbA1c change was measured at, and one year after, drug initiation. Similar to clinical trials, real-world patients had a baseline HbA1c 7% to 10%, were drug-treated, but did not take insulin at baseline.

Real-world change in HbA1c was similar between the two drug classes (-0.52% GLP1 vs. -0.51% DPP4, P=0.90). In contrast, randomized clinical trials typically reported a larger reduction in HbA1c than these real-world findings (HbA1c change rates – 0.84% to -1.60% for GLP-1; -0.47% to -0.90% for DPP4). Medication adherence was defined as the proportion of days covered (PDC) by GLP-1 or DPP4 ≥ 80%.

The authors concluded that poor adherence with second line treatments such as GLP-1s and DPP4s prescribed to type 2 diabetes patients accounted for 75% of the reduced efficacy between real-world patient settings and clinical trial results.

About Intarcia Therapeutics, Inc.

Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines for up to a year and beyond has the potential to ensure improved patient adherence and compliance, which is very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins, peptides, antibody fragments, and other high-potency small molecules at or above body temperature, and to deliver them in a constant and consistent manner via Intarcia's proprietary technology platform, the Medici Drug Delivery System™. Intarcia continues to conduct research and development, utilizing its platform technology, to treat other chronic, serious disorders such as diabetes, obesity, autoimmune, and other serious diseases. For more information on the Company, please visit www.intarcia.com.

Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.

SOURCE Intarcia Therapeutics, Inc.

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