TrialWatch

Effect of Exenatide, Sitagliptin, or Glimepiride on Functional Beta-Cell Mass

ClinicalTrials.gov Identifier: NCT00775684

This study compares the effects of exenatide (Byetta), sitagliptin (Januvia), and glimepiride (Amaryl) on beta-cells, the cells in the pancreas that make insulin. While all of these drugs lower blood sugar, their effects on beta-cells are currently a very hot topic in the diabetes world. Based on studies of animals, it is thought that some of these drugs can actually restore the ability of beta-cells to make insulin and even protect beta-cells that are still working. Drugs that protect beta-cells may slow the progression of diabetes. The study will last for six months, and will involve visits to the clinic to have your beta-cell function measured. To be eligible for this study, participants must be between 18 and 70 years of age, have type 2 diabetes, and not already be taking Byetta, Januvia, or more than two other oral drugs for diabetes. This trial is conducted at the University of Pennsylvania in Philadelphia. For more information, contact Jariss Stevens at 215-746-2081 or at jariss.stevens@uphs.upenn.edu.

Phase 1 Study of FG-3019 in Subjects with Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

ClinicalTrials.gov Identifier: NCT00754143

This phase 1 trial is studying the safety and tolerability of FibroGen’s FG-3019 being developed to treat nephropathy, a serious disease of the kidney that can develop as a complication of diabetes. The drug works by inhibiting the action of connective tissue growth factor, which helps to reduce damage to the kidney from high blood sugar. To be eligible for this study, participants must be between 18 and 80 years old, diagnosed with type 1 or 2 diabetes, have specific indications of nephropathy, and cannot have had an organ transplant or have been on dialysis. The study lasts for 34 weeks, and participants will require an IV dose of the drug or placebo every two weeks for the first 12 weeks of the study. The study is recruiting at centers all across the country. Click the link above or contact Sandy Liaw at (650) 866-7248 or sliaw@fibrogen.com.

A Study of Metformin in Combination With Colesevelam (Welchol), Compared to Metformin Alone, in Patients With Type 2 Diabetes Mellitus Not Previously Treated With Drug Therapy, and the Effects of Colesevelam on Lipids and Glucose in Patients With Pre-Diabetes

ClinicalTrials.gov Identifier: NCT00570739

Colesevelam (more commonly known as Welchol) is a cholesterol-lowering drug that has also been shown to moderately lower blood sugar—a recent study in Archives of Internal Medicine showed about a 0.5% A1c decrease with Welchol treatment after 16 weeks. This phase 3 trial by Daiichi Sankyo, the makers of Welchol, looks at how the combination of Welchol and metformin affects A1c in patients with type 2 diabetes and pre-diabetes. The effects of Welchol on lipid and glucose levels in prediabetic patients will also be evaluated. To be eligible for this study, participants must be between 18 and 79 years of age, have type 2 diabetes or pre-diabetes, and must have been off antidiabetic drugs for three months. The study lasts 16 weeks and will probably include multiple visits to the study center. The study is enrolling in 31 locations across the country. For further information and a list of study sites, you can visit the link above or contact Mary Martini at 513-345-4017 or martini.maryl@kendle.com.