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December 31, 2012

A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes

ClinicalTrials.gov Identifier: NCT01718093

Sitagliptin is a DPP-4 inhibitor sold by Merck under the name Januvia; Merck also sells a combination therapy bringing together sitagliptin and metformin called Janumet. While Januvia and Janumet are only FDA-approved for use in type 2 diabetes, recent studies have indicated that Januvia can reduce insulin doses by about 10% in people with type 1 diabetes when taken in conjunction with insulin. While DPP-4 inhibitors cannot treat the primary symptoms of type 1 diabetes – only replacement insulin can compensate for the destruction of beta cells in the pancreas – a DPP-4 and metformin might still prove useful. This study is phase 4, which means it is investigating drugs that have already been FDA approved, though not for the treatment of type 1 diabetes. The trial will take between 10 and 15 weeks to complete, with participants making four on-site visits during that period.

Participants will be randomized to one of three arms of the study: one in which they take insulin with sitagliptin alone, another where they take insulin with only metformin, and another where they take insulin with both sitagliptin and metformin. The study will measure the glucose-lowering effect of each of these three permutations when taken in combination with insulin. To participate in the study, volunteers must be 13-18 years old, have an A1c between 7.5% and 10%, and be on intensive insulin management. Participants also need to have reached at least stage 4 on the Tanner Scale of physical development and have a C-peptide level of greater than 0.6 ng/ml. For a complete list of inclusion and exclusion criteria, visit the study’s ClinicalTrials.gov page. The study is looking to enroll 48 volunteers at the Baylor College of Medicine in Houston between now and the end of the study in December 2015. For more information, contact Kathy Shippy, RN by phone at 832-824-1268 or via email at klshippy@texaschildrens.org. –AW

A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes

ClinicalTrials.gov Identifier: NCT01665352

GLP-1 agonists like Novo Nordisk’s Victoza and Amylin’s Bydureon and Byetta have proven very successful as a treatment for type 2 diabetes, with benefits including significant A1c reduction, weight loss, and low risk of hypoglycemia. The only real drawback for this drug class is that all three approved GLP-1 agonists, and most of those in the pipeline, are injectable – not as ideal as taking a pill. As such, a pill (also called an oral agent) that could replicate even a measure of the success of injectable GLP-1 agonists would be of great interest. One such drug currently under development is TransTech’s TTP054. This phase 2A study seeks to assess the effect of this oral GLP-1 at different doses. Participants will be given either a placebo or TTP054 at 200 mg, 400 mg, or 800 mg. Over the course of the 12-week study, researchers will track participants’ change in A1c level, change in fasting plasma glucose, and change in body weight. The study will also keep track of how many volunteers achieve an A1c reduction of less than 7% and weight loss of greater than 2% of body weight.

Participants in the study must have type 2 diabetes and have been on a stable, at least 3-month regimen of either metformin alone or metformin with a single other acceptable oral antidiabetic drug. Volunteers’ A1c must be between 7% and 11% if on metformin alone and between 6.5% and 9.5% if on metformin and another agent. Exclusion criteria include history or evidence of diabetes-related complications, history of serious heart problems, uncontrolled hypertension, frequent hypoglycemia, or being a woman of child-bearing potential. The study is looking to recruit 175 participants at 19 locations in California, Colorado, Florida, Hawaii, Indiana, Kentucky, Maine, Nevada, New Jersey, New York, Ohio, South Carolina, Texas, and Virginia. For more information, contact Dr. Stephanie Gustavson at ClinicalTrials@TTPharma.com. –AW

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