How Much Would It Help If You Took Januvia and Metformin, . . . and a Sulfonylurea?

A few months ago the FDA approved JANUVIA as monotherapy – to be used by itself. It is also approved to be used in combination with metformin or thiazolidinediones (TZDs). The catch is that a person should only use JANUVIA when diet and exercise do not control diabetes well enough. It is not approved as a medication that someone should use as their first diabetes treatment. The studies that Merck, JANUVIA’s manufacturer, submitted to the FDA for approval, occurred with large numbers of people who already had been diabetic for some time. So, the FDA approved it for that type of patient. Merck also did not seek approval for doctors to prescribe JANUVIA along with sulfonylureas.

So if Merck discovers that there are benefits to using the drug in a new way for which the FDA did not approve it, technically the company has to go back to the FDA submit a supplemental application for thd new use. Nevertheless, it is true that doctors could prescribe Januvia in liberal combinations with other drugs, such as a sulfonylurea. However, they are going to be less inclined to do that until the FDA approves it. It gives physicains an extra assurance the it will be safe for patients. Furthermore, they generally like to prescribe medicine that has a proven track record.

Januvia’s maker wants to expand its use so this week it did file the necessary supplemental applications that included three proposals. Proposal number one requests approval to use JANUVIA as initial therapy, along with metformin. (Of course Merck, your doctor and everyone else want you to use any medication to supplement diet and exercise.) A recently concluded clinical trial found that its participants were able to reduce their A1C scores an average of 2.1% over 24 weeks of taking both JANUVIA and Metformin. 66% of the patients taking this combination were able to reduce their A1C scores to below 7%. Because this combination appears to be remarkably effective, Merck could be making the case that there are situations where diabetics would benefit from both medications right from diagnosis. We’ll see if the FDA agrees. It probably will.

Proposal number three asks for the FDA to approve JANUVIA as adjunct (additional) therapy with sulfonylurea medications. A study of this combination is complete, but the results have not yet been published.

Proposal number two brings three drugs together. If the JANUVIA and sulfonylurea isn’t getting th job done, Merck proposes to allow patients to also add metformin. Again, there is study data to support this decision, but it is not available to the public (or bloggers) yet.

JANUVIA is only for people with Type II diabetes. JANUVIA is for patients in whom diet, exercise and other diabetes medications did not work well enough.