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Study: Dapagliflozin efficacious up to 2 years

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ADA 71st Scientific Sessions

SAN DIEGO — New data demonstrate that the investigational type 2 diabetes drug dapagliflozin was effective in sustaining blood glucose reductions for up to 2 years as compared with glipizide, when both drugs were added to metformin therapy.

At 104 weeks, dapagliflozin (Bristol-Myers Squibb, AstraZeneca) plus metformin was associated with a –0.32% (95% CI, –0.42 to –0.21) change in HbA1c from baseline vs. –0.14% (95% CI, –0.25 to –0.03) with glipizide plus metformin. In addition, patients assigned to dapagliflozin achieved an average body weight reduction of –8.14 lb, while those assigned glipizide gained 2.99 lb, on average, at the end of the study.

The results are from a 52-week extension period of an initial 52-week trial. The phase 3 study examined up to 10 mg dapagliflozin per day; up to 20 mg glipizide per day; and 2,000 mg metformin per day. There were 624 patients when the 52-week extension began; of these 445 completed the extension to 104 weeks.

In the study, hypoglycemic episodes were reported 10 times more frequently in patients assigned to glipizide plus metformin (45.8%) than those assigned dapagliflozin plus metformin (4.2%). Adverse events suggestive of genital infections were more common in the dapagliflozin group (14.8%) vs. the glipizide group (2.9%). These events were mild to moderate in intensity, occurred mostly in the first year of the study and rarely led to discontinuation. No kidney infections were reported with dapagliflozin; two patients in the glipizide group reported pyelonephritis and one reported pyelonephritis followed by pyelocystitis. There was no clinically relevant change in renal function during the study.

According to a press release issued by the companies, there was no overall imbalance in malignant tumors in the entire dapagliflozin clinical program. However, there were imbalances in two tumor types in the dapagliflozin clinical trial program. Nine bladder cancers have been observed in 5,478 patients taking dapagliflozin and one bladder cancer has been observed in 3,156 patients in control groups. Six of these 10 participants had hematuria at baseline and five were diagnosed within 1 year after study initiation. Nine breast cancers have been observed in 2,233 women taking dapagliflozin and one has been observed in 1,053 women in control groups. All were diagnosed within 1 year after study start. In preclinical studies, dapagliflozin was not shown to be genotoxic or carcinogenic, and the investigational agent has no known off-target pharmacology, according to the release.

These clinical and preclinical data will be reviewed at the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting scheduled for July 19, 2011. The FDA accepted a New Drug Application (NDA) for dapagliflozin in March 2011. If approved, dapagliflozin would be the first in a new class of insulin-independent, oral type 2 diabetes agents.

According to the companies, within the new class of insulin-dependent, investigational type 2 diabetes agents that inhibit sodium-glucose cotransporter-2 (SGLT2) in the kidney, the 104-week results are the longest-term clinical data presented yet.

“As we advance our knowledge of how SGLT2 inhibitors may work as a potential treatment for patients with type 2 diabetes, long-term data become critical to assess a compound’s safety and its ability to sustain glycemic control,” Michael A. Nauck, MD, head of the Diabetes Center, Bad Lauterberg, Germany, and principal investigator of the study, said in the company press release. “These 2-year data demonstrated that patients taking dapagliflozin added to metformin sustained reductions in blood sugar levels over an extended period of time.”

For more information:

• Nauck MA. 0040-LB. Presented at: American Diabetes Association’s 71st Scientific Sessions; June 24-28, 2011; San Diego, Calif.

Disclosure: The study was sponsored by Bristol-Myers Squibb and AstraZeneca.

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