Trial Watch: November/December 2008 - diaTribe

TrialWatch

A Study of LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin

ClinicalTrials.gov Identifier: NCT00734474

We think one of the most promising drug classes is the glucagon-like peptide (GLP)-1 analogs. GLP-1 is a hormone produced in the intestines that helps to regulate insulin secretion and glucose metabolism, and not only does it lead to improved glycemic levels but also weight loss in most patients who take it. At the moment, there is only one on the market that has been approved by the FDA: Byetta (Amylin/Eli Lilly’s exenatide). In addition to Byetta and ‘once-weekly Byetta’ (this will be submitted to the FDA by mid-2009 according to the company), Lilly is in the midst of developing another once-weekly formulation, currently known as LY2189265. In this trial, they are comparing the effects on glucose control of LY2189265 to sitagliptin (Merck’s Januvia), a dipeptidyl peptidase (DPP)-4 inhibitor (www.diatribe.us/issues/2/learning-curve.php, www.diatribe.us/issues/8/learning-curve.php). To be eligible for this study, you must be between 18 to 75 years of age and have had type 2 diabetes for at least six months. You must also be able to tolerate a daily dose of at least 1,500 mg of metformin for six weeks prior to the study. For further information, you can call 1-877-CTLILLY (1-877-285-4559).

PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus

ClinicalTrials.gov Identifier: NCT00690066

If you’re like us, you’ve probably heard a billion sound bytes about stem cells in the papers, on TV, in presidential candidates’ speeches, you name it. This trial is investigating the use of a certain type of stem cells for treatment of early-stage type 1 diabetes—and regardless of your views on stem cell issues, you can relax because these cells come from adult donors, not from embryos. Researchers have found that these types of cells help to suppress the immune system and reduce inflammation, and they may help to slow or reverse the progress of type 1 diabetes. To be eligible in this study, you must have been diagnosed with type 1 diabetes within the past 16 weeks, and you’ll need to agree to a schedule of intensive glucose management during the trial. The researchers will give you an injection of stem cells and then track your insulin use and the function of your pancreas over time. The study is recruiting at several centers around the country. For more information, you can check out the link above or contact Dayna Buskirk at (352) 335-9383 or email at osiris@osiris.com.

Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-Based Primary Care

ClinicalTrials.gov Identifier: NCT00668590

Diabetes management differs from patient to patient, and from healthcare provider to healthcare provider. Researchers in this study aim to combine multiple elements of clinical decision making – particularly patient input – to create the most feasible management plans. The study is being conducted to see whether increased patient involvement in decision-making results in better adherence to diabetes self-care behaviors and improved health outcomes. To be eligible for the study you should be 40 years of age or older, have had type 2 diabetes for more than a year, have an A1C greater than 8.0%, and own a DVD player and television at home. The study is recruiting in several locations in Los Angeles, California. For more information, check out the link above or contact Visith Uy at visith@gmail.com.