Diabetes and prediabetes are on the rise: New medication in research trials

As the newest statistics from the CDC show, diabetes is an ever increasing problem for Americans. Almost 26 million adults in this country now have diabetes, an increase of 9% since 2008. Ninety to 95% of cases are type 2 diabetes, marked by a gradual inability of the body’s cells to respond to insulin, and eventually an inability to produce enough insulin. In addition, almost 79 million people in this country have prediabetes. The CDC has warned that if diabetes continues on its current course, it could affect a third of all adult Americans by 2050.

New drug being studied

A new oral medication for the treatment of type 2 diabetes may be on the horizon. After promising results from preclinical studies and an initial Phase 1a trial in humans of their new drug, DB959, DARA Biosciences of Raleigh, NC has begun a Phase 1b clinical study for the drug. DB959 is a peroxisome proliferator activated receptor (PPAR) agonist of PPAR delta and PPAR gamma. It regulates certain nuclear receptors (PPARs) that in turn regulate the genes involved in controlling the levels of blood sugar and certain lipids, such as HDL, LDL, and triglycerides. Although there are other PPAR drugs currently on the market for the treatment of type 2 diabetes, such as rosiglitazone and pioglitazone, DB959 is in a different chemical class and has demonstrated a very different preclinical safety and pharmacological profile.

Appears safe and effective

In preclinical studies, DB959 appears to have a favorable effect on blood lipids as well as blood sugar; it raises HDL while lowering both triglycerides and blood glucose. These results were accomplished without causing the weight gain that is seen with other PPAR

agonists. The results of the Phase 1a clinical trial revealed a promising safety profile for DB959 and a pharmacokinetic profile that supports a once-a-day oral dose. The safety of DB959 was similar to placebo up to the highest dose of 200 mg, which is well beyond the anticipated therapeutic dose.

New trial beginning

DARA is currently initiating a multiple ascending dose trial to determine the safety and pharmacokinetics of oral doses of DB959 in both male and female subjects. Results are expected in the third quarter of this year. If these results are as promising as those from earlier studies, the next step will be testing DB959 in patients with diabetes to evaluate efficacy.