Phase IIb Data Showed Merck's Investigational Once-Weekly DPP-4 Inhibitor MK-3102 Significantly Lowe
Phase IIb Data Showed Merck's Investigational Once-Weekly DPP-4 Inhibitor MK-3102 Significantly Lowered Blood Sugar in Patients with Type 2 Diabetes
Phase III Trials of MK-3102 Underway
BERLIN--(BUSINESS WIRE)-- Merck (NYSE: MRK) , known as MSD outside the United States and Canada, today announced Phase IIb data for MK-3102, the company's investigational once-weekly DPP-4 inhibitor in development for the treatment of type 2 diabetes. MK-3102 significantly lowered blood sugar in this 12-week study compared with placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo, in patients with type 2 diabetes. These data were presented today at the 48th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin.
"If approved, MK-3102 would provide a novel, once-weekly treatment option to help reduce blood sugar levels in patients with type 2 diabetes," said lead study author Ira Gantz, M.D., Clinical Research, Metabolism, Merck Research Laboratories.
The findings reported today are from a multicenter, randomized, double-blind, placebo-controlled dose-ranging study designed to evaluate five doses of MK-3102 (0.25, 1, 3, 10 and 25 mg) in patients with type 2 diabetes who had inadequate glycemic control on diet and exercise.
A total of 685 patients with a mean baseline HbA1c of approximately 8 percent were randomized: 571 patients received MK-3102 at one of the five once-weekly doses (0.25 mg, n=113; 1 mg, n=115; 3 mg, n=114; 10 mg, n=115; 25 mg, n=114) and 114 patients received placebo for 12 weeks. The primary endpoint was change in HbA1c from baseline at 12 weeks compared to placebo across doses. The secondary endpoints were 2-hour post-meal glucose and fasting plasma glucose.
MK-3102 significantly reduced HbA1c compared to placebo (p<0.001) from a mean baseline of approximately 8 percent across all doses.In the full study population at 12 weeks, the placebo-adjusted reduction from baseline in HbA1c was 0.71 percent with MK-3102 25 mg; 0.67 percent with 10 mg; 0.49 percent with 3 mg; 0.50 percent with 1 mg; and 0.28 percent with 0.25 mg.
A statistically significant (p<0.001) trend was observed across doses studied for the secondary endpoints of 2-hour post-meal glucose (PMG) and fasting blood glucose (FPG). For 2-hour PMG placebo-adjusted reductions from baseline at week 12 were: MK-3102 25 mg=2.5 mmol/L; 10 mg=2.3 mmol/L; 3 mg=1.9 mmol/L; 1 mg=1.9 mmol/L; 0.25 mg=1.0 mmol/L. For FPG, placebo-adjusted reductions from baseline at week 12 were MK-3102 25 mg=1.2 mmol/L; 10 mg=0.7 mmol/L; 3 mg=0.8 mmol/L; 1 mg=1.1 mmol/L; 0.25 mg=0.1 mmol/L.
In the study, MK-3102 was generally well tolerated with a safety profile that was generally similar to placebo.
Diabetes is a chronic, progressive disease that affects 366 million people globally, including nearly 26 million people in the U.S., however, based on National Health and Nutrition Examination Survey (NHANES) data from 1999-2006, more than 40 percent of patients are not at the American Diabetes Association (ADA) goal of less than 7.0 percent for HbA1c.
"Since the discovery of the DPP-4 inhibitor class, Merck has been actively committed to advancing the science of how to treat type 2 diabetes. We are encouraged by these Phase IIb results in patients with type 2 diabetes, and we are initiating Phase III studies to move MK-3102 forward in the development process," said Nancy Thornberry, Senior Vice President and Franchise Head, Diabetes and Endocrinology, Merck Research Laboratories.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2011 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Pam Eisele, +1 908-423-5042
Kim Hamilton, +1 908-423-6831
Carol Ferguson, +1 908-423-4465
Justin Holko, +1-908-423-5088
KEYWORDS: United Kingdom United States Europe North America Germany New Jersey Ireland