Johnson & Johnson's type 2 diabetes drug trumps Januvia
  • Mon, 06/11/2012 - 3:53pm

According to data from five late stage clinical studies, Johnson & Johnson’s new anti-diabetic drug canagliflozin decreased blood sugar by a significant amount when compared to alternative treatments, such as Januvia and glimepiride.
In the five Phase 3 studies, individuals taking canagliflozin also lost more weight than individuals taking Januvia and glimepiride and experienced fewer episodes of hypoglycemia. According to WebMD, Hypoglycemia is a common symptom of diabetes in which an individual’s blood sugar level decreases, and can ranges from mild to severe.
As a SGLT2 inhibitor, canagliflozin treated Type 2 diabetes by blocking the reabsorption of glucose (sugar) by the kidney and expelling it into the urine, preventing high blood sugar. WebMD describes Type 2 diabetes as a condition that afflicts 90 to 95 percent of Americans, and occurs when the body cannot produce enough insulin or cannot process the insulin to provide the necessary glucose for the body’s cells.
In the Phase 3 studies, canagliflozin was compared with Merk & Co’s drug Januvia and glimepiride. The patients in the studies had previously experienced a loss of control over his or her blood sugar (loss of glycemic control) on the maximum effective doses of other anti-diabetic medications, such as sulfonylurea.
The results were measured in A1C levels, which measures blood sugar over time. 
Individuals on 300 milligrams of canagliflozin experienced an average one percent drop in A1C levels, while individuals taking Januvia only experienced a drop of .6 percent A1C level.
When 100 mg canagliflozin was compared with glimepiride in 1,450 patient study, both groups experienced similar decreases in A1C levels.
The 300 mg of canagliflozin was compared with glimepiride, the contrast was statistically significant. The difference was .93 percent for those taking canagliflozin and .81 percent for those taking Januvia.
Patients on canagliflozin also lost an average of 2.5 percent (about five pounds). Januvia, however, had practically no impact on weight loss for patients.
Patients experienced 4.2 percent weight loss on 100 mg canagliflozin, and 4.7 percent weight loss on 300 mg canagliflozin. Glimepiride, however, did not lead to weight loss, but resulted in a 1 percent weight gain on average.
Both patients on canagliflozin and Januvia underwent episodes of hypoglycemia at a similar rate––around 40 percent. More individuals discontinued use of Januvia due to loss of glycemic control than those taking canagliflozin––22.5 percent as opposed to 10.6 percent.
Incidents of hypoglycemia were statistically significant when canagliflozin was compared with glimepiride. Patients on canagliflozin with at least one incident of hypoglycemia was 5.6 percent for 300 mg, while patients on glimepiride with at least one incident of hypoglycemia was 34.2 percent.
Patients on canagliflozin experienced more genital infections and the need for increased urination. Urinary tract infections occurred in the same amount in both groups.
These effects were generally mild and short-lasting, and rarely lead to discontinuation of either drug. Discontinuation due to adverse events was greater in those taking canagliflozin, but was overall low in both groups.


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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