Omarigliptin significantly reduced HbA1c levels compared to placebo

VIENNA - Thursday, September 18th 2014 [ME NewsWire]

(BUSINESS WIRE)-- MSD, known as Merck & Co., Inc. (NYSE:MRK) in the United States and Canada, today announced the presentation of the first data from the Phase 3 clinical development program for omarigliptin, MSD’s investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes. In a study in Japanese patients, omarigliptin provided comparable efficacy and tolerability to MSD’s once-daily DPP-4 inhibitor, JANUVIA® (sitagliptin) 50 mg, which is the standard starting dose for sitagliptin in Japan.1 MSD presented these data on omarigliptin, which has been shown to produce sustained DPP-4 inhibition, at an oral session at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting.

“Despite advances in diabetes care in recent years, many people living with type 2 diabetes are not at recommended blood sugar goals,” said Peter Stein, M.D., vice president, Clinical Research, Diabetes and Endocrinology, Merck Research Laboratories. “MSD is committed to helping patients reduce the complexities of managing diabetes. If approved, omarigliptin, as a once-weekly medication, could provide an important new treatment option to help patients attain their blood sugar goals.”

MSD is supporting omarigliptin with a global clinical development program that includes 10 Phase 3 clinical trials involving approximately 8,000 patients with type 2 diabetes. These are the first Phase 3 data presented for omarigliptin and are the pivotal data for filing in Japan. As previously announced, MSD plans to file for approval in Japan by the end of 2014.

About the study

The Phase 3 double-blind, non-inferiority trial assessed the efficacy, safety and tolerability of omarigliptin 25 mg once-weekly compared to sitagliptin 50 mg once-daily (standard starting dose in Japan), and to placebo. The primary efficacy endpoint was the change in HbA1c* levels from baseline at week 24.

At baseline, randomized patients (n=414) had a mean HbA1c concentration of 7.9, 8.0 and 8.1 percent in the omarigliptin, sitagliptin and placebo groups, respectively. Mean fasting plasma glucose (FPG) levels were also similar between treatment groups.

The primary objectives of the study were met, demonstrating at 24 weeks a significant change from baseline in lowering HbA1c levels versus placebo, while demonstrating similar efficacy to sitagliptin.

At week 24, omarigliptin significantly reduced HbA1c levels by -0.80 percent from baseline relative to placebo. The change relative to sitagliptin was -0.02 percent and met the prespecified non-inferiority criterion. The pre-specified criterion was based on the upper bound of the 95 percent confidence interval (CI) being less than 0.3 percent. Fasting and two-hour post-meal blood sugar levels also were significantly reduced from baseline with omarigliptin and sitagliptin compared to placebo.

There were no meaningful differences in the incidences of adverse events with omarigliptin compared to placebo and sitagliptin. The most common adverse event that occurred with an incidence of greater than 3 percent in the omarigliptin group was nasopharyngitis, which occurred in 12.7 percent of those treated, compared to 30.5 percent of patients receiving placebo and 11.0 percent of those receiving sitagliptin. Symptomatic hypoglycemia was uncommon across all treatment groups in this study [omarigliptin (0), sitagliptin (1), and placebo (0)]. Omarigliptin was generally weight neutral, with a 0.04 kg mean change from baseline at week 24.1

About JANUVIA® (sitagliptin)

JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus as initial therapy, alone or in combination with metformin, or a PPARγ agonist, or as an add-on to metformin, PPARγ agonist, sulfonylurea, sulfonylurea + metformin or PPARγ agonist + metformin when the current regimen, with diet and exercise does not provide adequate glycemic control. JANUVIA can also be used as an adjunct to diet and exercise to improve glycemic control in combination with insulin (with or without metformin).

Important Selected Safety Information About Sitagliptin

JANUVIA is contraindicated in patients who are hypersensitive to any components of this product. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. Because these reports are made voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of JANUVIA. If pancreatitis is suspected, JANUVIA and other potentially suspect medicinal products should be discontinued. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency or with end-stage renal disease requiring hemodialysis or peritoneal dialysis.

As with other antihyperglycemic agents, when JANUVIA was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of sulfonylurea- or insulin-induced hypoglycemia was increased over that of placebo. To reduce the risk of sulfonylurea- or insulin-induced hypoglycemia, a lower dose of sulfonylurea or insulin may be considered.

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA including anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first 3 months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes.

In clinical studies as monotherapy and in combination with other agents, the adverse experiences reported regardless of causality assessment in ≥5% of patients and more commonly than placebo or the active comparator included hypoglycemia, nasopharyngitis, upper respiratory tract infection, headache, and peripheral edema.

For additional adverse experience information, see the product circular.

In clinical studies, the safety and effectiveness of JANUVIA in the elderly (≥65 years) were comparable to those seen in patients <65 years. No dosage adjustment is required based on age. In elderly patients with significant renal insufficiency dosage adjustment may be required.

Before initiating therapy, please consult the full prescribing information.

About MSD

Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. 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.msd.com.

Forward-Looking Statement

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. These statements are based upon the current beliefs and expectations of MSD’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; MSD’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of MSD patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

MSD 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 MSD’s/Merck’s 2013 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).

JANUVIA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

* HbA1c is an estimate of a person's average blood glucose over a two- to three-month period.

1 Gantz, I et al. Effect of a novel once weekly DPP-4 inhibitor, omarigliptin in patients with type 2 diabetes: a double-blind, placebo- and sitagliptin-controlled, non-inferiority trial. Presentation 115, presented at 50th EASD Annual Meeting on September 17 2014. Available athttp://www.easd.org/images/easdwebfiles/annualmeeting/50thmeeting/Prog-at-Glance.html. Last accessed September 2014

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