trial watch

Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

by Amro El-Adle and Alasdair Wilkins

ClinicalTrials.gov Identifier: NCT01681290

Diabetic neuropathy, or damage to nerves, affects about half of all people with diabetes at some point in their lifetimes. One of the most common forms of this diabetes complication is diabetic peripheral neuropathy (DPN), which primarily affects the legs and feet. While improved glucose control remains an effective method of slowing down and even reversing DPN, several drugs and devices are also available to treat the symptoms of DPN, including the recently approved Nucynta ER from J&J (see new now next in diaTribe #47) and Neurometrix’s Sensus (see new now next in diaTribe #46). A new candidate to treat DPN is Cebix’s CBX129801 (Ersatta), which utilizes a synthetic form of the protein C-peptide. This 52-week study will give participants weekly subcutaneous injections of CBX129801 at either 2.4 mg or 0.8 mg doses. The study will track what benefits the drug offers participants in terms of relief of DPN-related pain intensity, as well as the sensitivity and vibration perception of the affected nerves. Participants must be between the ages of 18 and 65, have had type 1 diabetes for at least five years, show at least one sign of DPN but be otherwise healthy, and be C-peptide deficient. There are also several exclusion criteria, all of which are available here. The study is looking to recruit 240 participants at the Diablo Clinical Research facility at Walnut Creek, California, located about 16 miles east of Oakland. For more information about the study, contact Cebix’s Mark Daniels at 1-858-729-6505 or at mark@cebix.com. 

A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

by Alasdair Wilkins

ClinicalTrials.gov Identifier: NCT01691755

Roche’s Aleglitazar is an example of a new drug class known as dual-PPAR agonists. PPARs (short for peroxisome proliferator-activated receptors) are types of proteins involved in the regulation of gene expression. Different types of PPARs play different roles – PPAR-alphas regulate cholesterol and lipid levels, while PPAR-gammas deal with the body’s sensitivity to insulin. TZDs (short for thiazolidinediones) work with the body’s PPAR-gammas to increase insulin sensitivity and lower blood glucose levels (see learning curve in diaTribe #6 and new now next in diaTribe #47). Takeda’s Actos (pioglitazone) and GSK’s Avandia (rosiglitazone) are examples of TZDs that have been previously approved for type 2 diabetes (though use of Avandia was subsequently restricted by FDA in 2010 due to cardiovascular risk concerns).

Aleglitazar modulates both PPAR-alpha and PPAR-gamma, which means it can potentially treat both high blood sugar and high blood cholesterol. This phase 3 study will track changes in A1c, blood glucose, and lipid profile over 26 weeks. Participants must be at least 18 years of age, have type 2 diabetes, have an A1c between 7.0% and 9.5%, a fasting blood glucose no greater than 240 mg/dl, and be willing to maintain a diet and exercise regimen during the study. People who have previously been on a treatment program using TZDs or dual PPAR agonists, are not eligible for the study. A full list of inclusion and exclusion criteria can be found here. The study is looking to enroll 200 participants and is recruiting at 33 locations in 13 states (CA, FL, GA, IL, IN, MD, MO, NC, ND, OR, PA, SC, WA) as well as El Salvador, Guatemala, and Mexico. For more information, email genentechclinicaltrials@druginfo.com – be sure to reference the study ID number BC28034 in your email. Prospective participants in the United States can also call 1-888-662-6728.