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Compare Januvia and Galvus Diabetes Drugs - Both Lower Blood Sugar with Fewer Side Effects than Glipzide Glucotrol - Weight Loss Too

June 13th 2006

Compare Januvia and Galvus Diabetes Drugs - Both Lower Blood Sugar with Fewer Side Effects than Glipzide Glucotrol - Weight Loss Too

Glucose Monitor

Two pills from competing pharmaceuticals have shown promise in trials as an effective treatment for type-2 diabetes, but without the side effects.  Other drugs on the market can cause low blood sugar and weight gain side-effects, so these new drugs may be better. 

It is hoped the drugs will reach the US market in less than a year.  Forbes has reported that the combined sales could reach $5 billion by 2010.  The drugs, Januvia and Galvus (made by Merck and Novartis respectively), spare the side effects while preserving the beta cells in the pancreas.  These cells produce insulin which helps reduce glucose in the blood.  They usually die off in diabetes patients. 


There are 21 million Americans with diabetes.  The disease puts them at a higher risk for heart attacks, kidney disease and blindness.  Type-2 diabetes is the most common form and usually comes with age.  A poor diet and lack of exercise usually leads to type-2 diabetes. 

Both Januvia and Galvus help preserve the beta cells in the pancreas.  These are the cells that produce insulin.  They inhibit an enzyme called dipeptidyl peptidase 4 (DPP-IV), which breaks down hormones that help control blood sugar. 

In a 800 patient study, Januvia was tested over a year period and was found to control blood sugar levels as well as the current treatment, glipizide (Glucotrol), a commonly used diabetes drug sold by Bristol-Myers Squibb.  While patients on the traditional drug, glipzide, gained an average of 2.4 pounds, the Januvia patients actually lost weight.  Also, 32% of the patients on Glucovance had an episode of low blood sugar, while only 5% of those on Januvia did.  The Januvia side effects were similar to the side effects of the placebo sugar pill. 


Galvus shows as much promise.  A combination of Galvus and Actos, a diabetes medicine made by Takeda Pharmaceutical, allowed two-thirds of patients in one large study to adequately control their diabetes. Severely obese patients actually lost weight on the combination therapy.  Novartis will begin what they are calling the “GLORIUS” trials to prove the drugs benefits. 

Industry watchers say that for Galvus to be as effective as Januvia, patients will need to take it twice a day. Patients will only need to take Januvia once a day.  Both drugs are expected to replace the current medicines as the first line treatment for diabetes. 

James Shannon, MD, Head of Development at Novartis Pharmaceutical said "The magnitude of A1c reductions seen with the combination of Galvus and a TZD is encouraging for patients struggling to reach and maintain their blood sugar levels. The trial results for Galvus continue to reinforce the benefits of treating both islet dysfunction and insulin resistance in type 2 diabetes.”


A spokesperson for Novarti said throughout the Phase III program, Galvus has shown clinically significant and consistent A1c reductions both as monotherapy and in combination with other oral and injectable anti-diabetic agents. Galvus has demonstrated a good tolerability profile in these studies; with no weight gain overall and an incidence of hypoglycemia (excessively low blood sugar) and edema (fluid retention) similar to placebo in monotherapy trials.

Reuters reports that Merck has said it expects the U.S. Food and Drug Administration to decide whether to approve Januvia by mid-October.  The companies presented their data at the American Diabetes Association's 66th annual meeting. 

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Dan Wilson
Best Syndication

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