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 a 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.

a new drug takes aim at insulin resistance

Clinicaltrials.gov identifier: NCT00631007

If you are between the ages of 30-70 and have poorly controlled type 2 diabetes (A1c between 7.5 percent and 10 percent), you may be eligible to enroll in a clinical trial for an experimental drug (currently referred to as INT131) that may reduce insulin resistance. The trial will randomly assign patients to one of three doses of the drug, or to Actos (a drug that is already on the market that reduces insulin resistance – see Learning Curve in diaTribe #6 to learn more about it). This trial, which is sponsored by InteKrin (the company that is developing the new drug), is looking to enroll 360 patients at approximately 50 study locations across the U.S. Researchers began enrolling patients. For more information, please contact Jennifer Kelch on 513-579-9911 ext 2275.

januvia and actos: effects on glucose control

Clinicaltrials.gov identifier: NCT00511108

This study will compare the effects of Januvia alone and in combination with Actos on blood glucose control in people with type 2 diabetes. Januvia is a DPP-4 inhibitor and Actos is a thiazolidinedione (TZD). See Learning Curve in diaTribe issue #2 and Learning Curve in diaTribe #6 for a refresher on DPP-4s and TZDs, respectively. This study is open to men and women (who are unlikely to become pregnant) between 30 and 65 years old who experience poor glucose control with diet alone or in spite of taking up to two oral antidiabetic medications. If you have taken Actos or Avandia in the 12 weeks before joining the study, you will not be eligible to participate. This study is enrolling in centers across the US, Australia, Austria, Belgium, Israel, Italy, Spain, and the UK. To locate study centers, call 1-888-577-8839 or visit the link above for international contact details.

Otelixizumab may delay the full onset of type 1 diabetes

Clinicaltrials.gov identifier: NCT00451321

If you are between the ages of 18 and 60 and have newly diagnosed type 1 diabetes with minimal insulin requirements, you may want to consider enrolling in a clinical trial for a new experimental drug called otelixizumab. Researchers hope that it may help to protect the insulin-producing cells in the pancreas, thereby delaying the full onset of type 1 diabetes. In a previous trial, otelixizumab provided some protection for insulin producing cells in the pancreas for up to 18 months or more. Otelixizumab works by blocking the function of autoreactive T cells (known as T effector cells) – the immune cells that can attack insulin producing cells in the body leading to type 1 diabetes. The present clinical trial is sponsored by Tolerx, Inc. (the drug developer) as well as the Juvenile Diabetes Research Foundation (JDRF). The study organizers hope to recruit 100 volunteers at a variety of different sites in the US and in Canada. More information may be obtained by contacting Kathleen Osborn at clinicaltrials@tolerx.com or call 1-877-515-6672.

safety, efficacy and tolerability of albiglutide vs. byetta

Clinicaltrials.gov Identifier: NCT00518115

This study aims to test the efficacy, safety and tolerability of Syncria (albiglutide), a drug in the same class as Byetta. This study will be done over 16 weeks. Participants will receive Syncria, Byetta and/or guidance in general diabetes management. Data collection involves regular monitoring of blood glucose and side effects. In addition, researchers will record changes in A1c and other indicators such as waist circumference, weight, body mass index (BMI), fasting plasma glucose, and lipid levels. Researchers will also provide weekly visits and 10 weeks of follow-up visits after the study ends.

To participate, individuals must have type 2 diabetes and be treated with diet and exercise alone or with metformin. Participants may be male or female, and must be between the ages of 18 and 75 with a BMI between 20 and 40 ^kg/m2. Smoking during the study, serious cardiovascular problems, kidney or brain disease, and pregnancy are factors for exclusion. This study is being conducted in over 200 locations across the U.S. and in other countries such as Mexico, Peru and Chile. Call 1-877-379-3718 for more information. We think enrollment might be ending soon, so we suggest calling sooner rather than later if interested.

the lancet trial: the effect of lantus on c-reactive protein (CRP) in type 2s

Clinicaltrials.gov identifier: NCT00366301

Elevated levels of CRP are thought to be a risk factor for diabetes, stroke and heart problems. Studies have shown the beneficial effects of oral diabetes medications on lowering CRP levels, but have not compared these effects with those produced by insulin. Lantus is a long-acting insulin effective in maintaining control over blood glucose levels. This study will compare the effects of Lantus and metformin on CRP levels.

Study organizers are looking for 800 people with type 2 diabetes in 100 centers across the U.S. to participate in this trial. Individuals aged 17 to 79 years with early type 2 diabetes presently treated with diet or a single oral medication may participate. Eligibility criteria also include baseline A1c between 7 percent and 10 percent and CRP greater than or equal to 2.0 mg/l. For the study’s duration, participants may be treated with Lantus, metformin, a combination of both, or placebo. Everyone in the trial will receive diet and exercise counseling. To learn more, please contact Dr. Anna Das Pradhan at 617-432-8777, or Ellie Danielson at 617-278-0854.