TrialWatch

This column consists of a review of interesting diabetes-related clinical studies selected from recognized and reliable sources. Clinical studies are necessary for the development and government approval of diabetes drugs and devices and involve strict suitability, eligibility and safety criteria for participation. Please consult your healthcare team before enrolling in any clinical trial.

Increasing interest in incretins – the Duration 3 study

Clinicaltrials.gov identifier: NCT00641056

This trial is geared toward type 2 adults (18 and older) with A1c between 7% and 11% on metformin (alone or with a sulfonylurea). The study is comparing once-weekly exenatide (an incretin) and once-daily Lantus (insulin glargine). It will primarily compare the effects of these therapies on A1c in patients over 26 weeks. Additionally, researchers will compare the effects of these therapies on body weight, lipid profiles, (cholesterol etc), and frequency of hypoglycemia. Exclusion criteria include treatment with any of the following medications three months prior to enrolling in this trial: insulin, Glyset, Precose, Prandin, Starlix, Byetta, Symlin, Januvia, Actos, and Avandia. This study is enrolling approximately 456 patients at 77 centers worldwide (12 of which are located in the U.S.). For more information, please call 1-877-CTLILLY (1-877-285-4559).

Addressing health disparities – The Community Outreach And Cardiovascular Health (COACH) Study

Clinicaltrials.gov identifier: NCT00385619

People with diabetes or (at high risk for) heart disease may be eligible for enrollment in a study to test the effectiveness of a healthcare team approach in the management of risk factors for heart disease. The study will test whether a community health worker, nurse practitioner, and physician will enable a higher proportion of patients to reach goals for cholesterol, blood pressure, and blood sugar compared to those receiving standard care. One goal of this study is to test whether comprehensive prevention therapies with the team approach will decrease death from heart disease and from unequal access to healthcare in primary care practices treating underserved and minority populations. For more information, contact Carol Curtis at 410-614-6077 or at ccurtis@son.jhmi.edu.

Impact of insulin pump therapy vs. standard injection therapy

Clincialtrials.gov identifier: NCT00417989

This study could be an excellent way to figure out if insulin pump therapy (and continuous glucose monitoring) is (are) right for you. Researchers are looking for patients who have never used an insulin pump (or at least not within the last three years) in order to better understand the effects of pump/CGM therapy on A1c, frequency of hypoglycemia, and important health economic outcomes compared to standard insulin injection therapy. A total of 552 patients who test four or more times per day, are between the ages of 7 and 70, and have an A1c greater than 7.4% and less than 9.5% will be selected to participate in this 30-center trial. Participants will use the Medtronic Paradigm REAL-Time System. Find out more by contacting Brenda Parry at 818-576-5049 or at Brenda.perry@medtronic.com.