Data reported by Merck and Novartis show new compounds work as well as older diabetes drugs but with fewer side effects like weight gain and hypoglycemia.
The compounds, Januvia and Galvus, are part of a new class of drugs for Type 2 diabetes called DPP-IV inhibitors, which work by inhibiting an enzyme that breaks down incretin hormones that help control blood sugar.
Analysts say the two drugs, which could be approved this year, have the potential to bring in combined sales of $5 billion by 2010, if no major safety issues emerge.
Marketers presented the data at the ADA conference in Washington, DC. In one yearlong, 793-subject trial reported by Merck, Januvia controlled blood sugar as well as glipizide, a drug sold by Bristol-Myers Squibb under the name Glucotrol. But patients in the Januvia cohort lost weight slightly while those taking glipizide gained weight—2.4 pounds on average.
Januvia also was associated with fewer episodes of hypoglycemia than glipizide, with 32% of Glucotrol patients having at least one episode of low blood sugar compared to 4.9% of Januvia patients.
Galvus performed similarly well. When taken with pioglitazone, a diabetes drug marketed by Takeda Pharmaceuticals as Actos, tests showed the Galvus-Actos combination enabled two-thirds of patients to control glucose. On their own, each allowed 42% to reach an adequate level. Weight loss benefits were seen among severely obese Galvus-treated patients.
While there appears to be little difference between the two, Januvia is expected to be decided on by the FDA in October—three months ahead of Galvus. Analysts also say that Januvia may better fit the profile of a once-a-day drug, although both are being touted as once-daily treatments.