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Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

ClinicalTrials.gov Identifier: NCT01494987

Ranolazine (Gilead Sciences’ Ranexa) is a medication used to treat angina, a chronic chest pain condition that occurs when not enough oxygen reaches the heart. Previous clinical trials have revealed improved blood glucose as a possible side effect of ranolazine, with A1c declines as large as 0.7% observed in some trials. This phase 3 study is primarily focused on ranolazine’s ability to reduce A1c levels over a 24-week period when taken with the diabetes drug glimepiride (a sulfonylurea). The experimental group will take ranolazine tablets twice daily in combination with glimepiride, while the control group will take placebo alongside glimepiride. Study participants must have type 2 diabetes, an A1c between 7% and 10%, and can be anywhere from 18 to 75 years old with a BMI between 27 and 45 kg/m². Participants must also be on a sulfonylurea or metformin therapy for at least ninety days before beginning the trial. Given ranolazine’s background as a cardiovascular drug, most research has focused on its potential use by people with diabetes who also have coronary artery disease. However, diabetes patients do not need to have any heart condition to participate in this study. For a full list of inclusion and exclusion criteria, click here. The study is recruiting at 121 total locations worldwide, including 44 locations in 20 states (AZ, AR, CA, FL, GA, ID, IL, IN, KY, LA, MD, MI, NM, NC, OH, OK, SC, TN, TX, UT) as well as additional locations throughout Eastern Europe, Southeast Asia, and South Africa. For more information, contact Millie Gottwald of Gilead Sciences at mgottwald@gilead.com. –AW

Effects of Metreleptin in Type 1 Diabetes Mellitus

ClinicalTrials.gov Identifier: NCT01268644

In rodents with diabetes, treatment with a combination of leptin and insulin has been associated with a stable pattern of glucose control and reduced insulin requirements. With this in mind, researchers at the University of Texas Southwestern Medical Center have begun a human trial studying the efficacy of metreleptin (an analog of the human hormone leptin, manufactured by Amylin Pharmaceuticals) in regulating glucose levels in people with type 1 diabetes. The study will compare combined leptin and insulin therapy to insulin therapy alone – the hope is that combination therapy will lead to a stronger improvement in A1c after five months of treatment vs. insulin use alone. Participants must have type 1 diabetes, an age 18-50 years, an A1c between 7.0% and 10.0%, must be currently using either an insulin pump or a mix of basal and mealtime insulin therapy, and have a BMI less than 27 kg/m². Additional study criteria can be found here. The researchers plan to enroll 15 participants in the vicinity of Dallas’s UT Southwestern Medical Center. –AW