Merck says new data shows Januvia with metformin improves

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Drug manufacturer Merck & Co. Inc. (MRK: News ) said Tuesday new data analyses showed that initial combination therapy with Januvia, or sitagliptin, and metformin improved blood sugar levels over two years of treatment and was generally well tolerated in patients with type 2 diabetes.

Januvia is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type-2 diabetes. More than six million total prescriptions for Januvia have been dispensed worldwide since launch and it has received approval in 80 countries, the company added.

The data was collected from a double blind 54-week base study involving 412 patients who received combination therapy with Januvia and metformin. The study also demonstrated that the combination therapy significantly improved blood sugar levels compared with either metformin or Januvia alone over two years of treatment.

The company added that data from a pooled analysis of clinical studies with Januvia up to two years showed that the drug was well tolerated, with generally similar incidence of adverse experiences.

The pooled analysis evaluated data from 12 large, double-blind, randomized, completed Phase IIb and III studies of 18-weeks to two years duration that included 6,139 patients receiving either Januvia once-daily or placebo or an active comparator. The studies assessed Januvia as monotherapy, initial combination therapy with metformin or add-on therapy to oral antihyperglycemic agents.

In a separate 52-week investigational study involving 262 patients, the company found that the addition of Januvia to the combination of metformin and rosiglitazone significantly improved glycemic control in patients with type-2 diabetes.

In another 52-week study of Japanese patients, treatment with Januvia added to ongoing pioglitazone therapy provided effective glycemic control and was generally well tolerated with a comparable occurrence of hypoglycemia in the placebo and Januvia groups, and without clinically meaningful change in body weight.