TrialWatch
CANVAS: CANagliflozin cardioVascular Assessment Study
ClinicalTrials.gov Identifier: NCT01032629
The CANVAS study is designed to examine the cardiovascular safety of canagliflozin, a new drug in development in a class called SGLT2 inhibitors. SGLT2 inhibitors allow the kidneys to excrete glucose instead of conserving it in the bloodstream, thus lowering blood sugar. In addition to limiting hyperglycemia, this drug class has shown significant weight loss in clinical trials, which could lead to further benefits in treating type 2 diabetes. Currently, there are no SGLT2 inhibitors approved by the FDA, although canagliflozin is one of several currently in clinical trials. Participants in this study will be randomized to take one pill per day that will contain one of the following: a placebo, 100mg canagliflozin, or 300 mg canagliflozin. The length of the study is expected to be four years, during which study participants will be monitored for any major cardiovascular problems. To be eligible for this study, you must have type 2 diabetes, a high risk for cardiovascular disease, and an A1c between 7.0% and 10.5%. You must also be aged 30 or older. For more information on how to participate, you can go here or you can email info1@veritasmedicine.com with any questions.
Protege Encore Study: Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
ClinicalTrials.gov Identifier: NCT00920582
This study is currently recruiting patients recently diagnosed with type 1 diabetes to investigate the efficacy of teplizumab, a drug that may be able to slow the progression of diabetes. This drug, like TolerX’s otelixizumab, binds to a protein called CD3 and prevents it from functioning. This protein occurs in people with and without type 1 diabetes, but it has been implicated as a critical component in disorders where the immune system attacks the body. In the case of type 1 diabetes, the immune system attacks beta cells of the pancreas. This class of drug has so far shown to maintain some insulin secretion in people with newly diagnosed type 1 diabetes, but the effect does not last forever. Nonetheless, it is thought that reducing hyperglycemia early on in the disease progression can have benefits later on. You can read more detail on this drug class in our Learning Curve from diaTribe #15. In this study, patients will be randomized to receive daily injections of either a placebo or teplizumab. There will be two courses of treatment, each lasting two weeks. To be enrolled in this study, subjects must be 8-35 years old, weigh more than 36 kg (79 lb), and have a confirmed diagnosis of type 1 diabetes. To learn more about joining this study, please contact Angela Fields at 301-348-1608 or afields@mmgct.com.
DSS: Diabetes Surgery Study – Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
ClinicalTrials.gov Identifier: NCT00641251
Although bariatric surgery was developed to help people lose weight, an unexpected side effect of the surgery has been drastic improvements to blood glucose levels in people with diabetes (for more on the effects of bariatric surgery on diabetes, see diaTribe #18). Roux-en-Y gastric bypass, a type of bariatric surgery, often totally resolves the symptoms of type 2 diabetes. This trial explores the effectiveness of bariatric surgery to lower A1c, blood pressure, and LDL cholesterol in people with type 2 diabetes. Patients are randomized to receive either intensive medical management of their diabetes without surgery or with Roux-en-Y gastric bypass surgery. To be eligible, participants must be between 35 and 67 years old, must have been diagnosed with type 2 diabetes for at least 6 months, and must have a body mass index (BMI) between 30.0 and 34.9 kg/m2 (you can calculate your BMI here). The study is being conducted at hospitals in New York City and Minneapolis. To enroll in New York City, please contact Heather Bainbridge at 212-305-0486 or dssresearch@columbia.edu; to enroll in Minneapolis, please contact Joyce Schone at 612-273-4860 or jschone1@fairview.org.