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The Efficacy and Safety of Liraglutide with Insulin in Type 1 Diabetes (ADJUNCT TWO)

Published: 8/7/14
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ClinicalTrials.gov Identifier: NCT02098395

Victoza (liraglutide) is a once-daily GLP-1 agonist made by Novo Nordisk and FDA approved for the treatment of type 2 diabetes. GLP-1 agonists are injectable drugs (once daily in the case of Victoza) that stimulate the pancreas to release insulin when blood glucose levels are high. These drugs also prevent the release of glucagon, the hormone that raises blood glucose. Several small studies have shown that GLP-1 agonists also work in type 1 diabetes to improve A1c, time in zone (less hypoglycemia and hyperglycemia), reduce insulin doses, and help with weight loss – you can read our conference pearls to learn more. Editor-in-chief Kelly Close also wrote about her experience using Victoza off-label in our test drive.

The six-arm, 26-week study will compare different dosages of Victoza to placebo, both added on top of insulin. Participants must be over 18 years old, have had type 1 diabetes for at least 12 months, and have been treated with insulin for at least six months. Exclusion criteria include past GLP-1 receptor agonist or DPP-4 inhibitor use, severe neuropathy, and high blood pressure, among other conditions. The study will enroll 804 subjects in multiple countries, including the United States and trials are currently recruiting in AZ, AR, CA, CO, GA, IL, IA, KY, MD, MN, MS, MT, NY, NC, ND, TX, UT, VT, and WA. Interested parties should email [email protected]. – BH/NL

Comparison Between a New Drug for Type 2 Diabetes and Exenatide Extended-release

ClinicalTrials.gov Identifier: NCT02119819

This Lilly-sponsored study will compare a new oxyntomodulin analog (“ LY2944876”), which has dual agonist activity of the GLP-1 and glucagon receptors, to both placebo and Bydureon (exenatide extended-release), a once-weekly GLP-1 agonist. This exploratory drug class has been associated with reduced appetite as well as increased metabolism.

The study is expected to take 30 weeks, with the first 12 involving blinded treatment and the next 12 unblinded. Subjects must be living with type 2 diabetes, be between 18 and 80 years old, have an A1c between 7.0% and 10.5%, and a BMI between 23 and 45 kg/m2, among other criteria. Women who are potentially pregnant, people who have used hyperglycemic treatment drugs besides metformin, and people with impaired kidney function cannot participate. The trials will take place in the Americas and Europe, including the United States (CA, FL, HI, ID, IA, KN, MS, NH, NC, ND, OR, PA, TN, TX, and UT). For more information, please visit the ClinicalTrials.gov website or please call 1-317-615-4559 or 1-877-CTLILLY. – BH

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