trial watch

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

ClinicalTrials.gov Identifier: NCT01658579

While Sanofi’s Lantus (insulin glargine) has emerged as the standard for basal insulin, companies such as Novo Nordisk, Eli Lilly, and Sanofi itself are still working on new long-acting insulins that offer more flexible dosing options, less risk of hypoglycemia, and other novel features that distinguish them from Lantus. Sanofi previously announced its own new, clinically different formulation of Lantus was in phase 3 trials (see new now next in diaTribe #38), and it is now undertaking an additional phase 2 study comparing the effectiveness of the current, FDA-approved version of Lantus with this new formulation. The trial is primarily focusing on the percentage of time participants spend in their target glucose range on either version of insulin glargine, although the trial will also monitor changes in A1c and fasting plasma glucose as well as incidence of hypoglycemia. Participants must have type 1 diabetes and an A1c no greater than 9.0% – a full list of the exclusion criteria is available here. The study is currently recruiting 56 participants at Sanofi’s investigation sites in Minneapolis, MN (site #840001) and Temecula, CA (site #840002). For more information, please send an email with the number of your preferred site to contact-us@sanofi-aventis.com. –AW

The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin Therapy (DUAL III)

ClinicalTrials.gov Identifier: NCT01676116

IDegLira is Novo Nordisk’s combination of its GLP-1 agonist Victoza and its ultra-long-acting insulin degludec, which is still pending approval from the FDA and other global regulatory agencies. By combining the two therapies in a fixed ratio – which means any increase in the amount of insulin would also require a proportional increase in Victoza – IDegLira has so far demonstrated improved glycemic control, potential for weight loss, and less risk of hypoglycemia than insulin alone. Last month, Novo Nordisk announced updates on its phase 3 IDegLira trials (see new now next in diaTribe #46), with the DUAL I trial producing favorable results and the DUAL II trial on track to complete by the end of the year. The company is now beginning work on the DUAL III trial, which will compare the change in participant A1c levels when taking IDegLira and metformin compared to taking metformin and either just insulin degludec or just Victoza. Participants must have type 2 diabetes, an A1c between 7.0% and 9.0%, a BMI no greater than 40 kg/m², and be using a daily GLP-1 agonist as part of their treatment for at least 90 days before beginning the study. A full list of the inclusion and exclusion criteria is available here. The study is looking to recruit 429 participants at 55 locations in 24 states (AL, AZ, CA, FL, GA, IL, IN, KY, MD, MI, MO, NE, NV, NH, NJ, NY, NC, OH, PA, TN, TX, UT, VA, WA) as well as additional locations in Australia, France, and Slovakia. For more information, call the Novo Nordisk Clinical Trial Call Center at 866-867-7178. –AW

Diabetic Gastroparesis Efficacy/Safety Study of TZP-102 (DIGEST)

ClinicalTrials.gov Identifier: NCT01664637

Gastroparesis is a special form of diabetic neuropathy that affects the vagus nerve, which controls the passage of food through the digestive tract. Damage to this nerve disrupts the movement of food through the stomach and intestines, which can make management of diabetes much more difficult, as the delays in stomach emptying tend to lead to sudden blood glucose spikes. Gastroparesis is also known to cause nausea, vomiting, heartburn, bacterial overgrowth in the stomach, the formation of solid masses of undigested food, and a number of other unpleasant side effects. As with other diabetes complications, improved glucose control is a key part of relieving symptoms, and gastroparesis can also be treated orally with medications such as erythromycin (e.g., E-Mycin) and metoclopramide (e.g., Reglan). A new candidate to treat diabetic gastroparesis is Tranzyme’s TZP-102. The company is currently recruiting for a 12-week phase 2 trial to test the effectiveness and safety of taking a 10 mg dose of TZP-102 three times a day before each meal. Participants should be between 18 and 80, have either type 1 or type 2 diabetes, and have documented history of gastroparesis and its symptoms for at least three months before beginning the study. Tranzyme is looking to enroll 120 participants at its Investigational Site in Ventura, CA. For more information, please contact Beth Chamblin at 919-328-1132 or bchamblin@tranzyme.com. –AW