A Study to Evaluate the Effect of ASP1941 (SGLT2 inhibitor) in Adult Patients of Type 2 Diabetes

ClinicalTrials.gov Identifier: NCT01071850

This phase 2 clinical trial will evaluate the efficacy of multiple doses of ASP1941, a drug in the new SGLT2 inhibitor class (for more on SGLT2 inhibitors, see Learning Curve from diaTribe #8). SGLT2 inhibitors encourage the kidneys to excrete glucose instead of reabsorb it into the bloodstream, thus lowering blood sugar through the passage of excess glucose in the urine. In addition to limiting high blood sugar, this class of drugs has been associated with some weight loss in clinical trials, which could lead to further benefits for type 2 patients. Currently, there are no SGLT2 inhibitors approved by the FDA, although ASP1941 is one of several currently in development. Participants in this study will be randomized to take one pill per day (orally) that will contain one of the following: one of four different doses of ASP1941, metformin, or placebo. Patients will be expected to take the therapy for 12 weeks and A1c values will be evaluated both at the beginning and the end of the study period. To be eligible to participate in this study, you must be diagnosed with type 2 diabetes, have an A1c between 6.8-9.5%, on a stable diet and exercise program, and over the age of 18 years old. You must also be new to taking oral anti-diabetes medications, or if you are taking one or two low-dose oral antidiabetes medications, you must be willing to discontinue use during the study. For more information on joining this trial, please contact Astellas Pharma Global Development at 800-888-7704 ext. 5473 or clintrials.info[AT]us.astellas.com.