Januvia Approvals

Januvia is a new treatment drug has been approved by the FDA for the treatment of Type 2 diabetes. Januvia is a DPP – 4 inhibitor which helps in controlling the blood sugar levels in the body.

Januvia was cleared as a monotherapy in October 2006 and also as an add on therapy with metformin or thiazolidnediones to improve the control over blood sugar levels, when diet and exercise is not as satisfactory. Januvia improves the body’s own ability to lower the elevated blood sugar. It improves the glycemic control in patients who suffer from type 2 diabetes.

The European commission has also given Januvia a positive response, and has even recommended Januvia for the effective treatment of type 2 diabetes, but is still to give Januvia a proper approval which would in turn allow the drug to be sold in 27 EU member countries. This drug slows the inactivation of incretin hormones and helps in prolonging its action.

Januvia got a positive opinion from the committee for Medicinal products for human use of European medicines evaluation agency. After proper action on the recommendation of the drug, it should be in the europe market by April where Merck expects full marketing.

Januvia Trials

According the U.S FDA approval, there were trials which were conducted on Januvia are:

• Monotherapy Trials
  one with duration of 18 weeks and one with 24 week duration. In the 18 – week trial around 521 subjects were randomized to placebo, and in the 24 week trial 741 subjects were randomized to placebo. Treatments in which Januvia was used showed a lot of improvement in patients in A1C, FPG and a 2 hour PPG compared to placebo.
  
  
• Combination therapy trials
  This trial was designed to compare Januvia along with metformin as a treatment schedule for 24 weeks, which was quite successful as there was improvement which was seen in A1C, FPG and 2 hour PPG as compared to placebo and metformin.

The information mentioned above should not replace your doctor’s advice.

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