TrialWatch

Januvia Added-on to Insulin Study

This phase 3 study will test the efficacy of adding Januvia therapy for type 2 patients who are not at glycemic goal on insulin or insulin and metformin. Sitagliptin (or Januvia) is the only DPP-4 inhibitor currently approved by the FDA; it improves the body's ability to secrete insulin appropriately and thus complements the actions of injected insulin.

Randomized Study of Real-Time Continuous Glucose Monitors in the Management of Type 1 Diabetes

This phase 2/3 JDRF-organized clinical trial will be testing three different continuous glucose monitors in the management of type 1 diabetes. Volunteers must have type 1 diabetes and be at least eight years old. The devices being tested are Abbott's FreeStyle Navigator, DexCom's STS, and Medtronic Minimed's Paradigm or Guardian REAL-Time monitor.

Galvus vs. Thiazolidinedione as Add-on Therapy to Metformin (GALIANT)

This very large phase 3 study (8,000 patients) will compare the efficacy of adding Galvus or a thiazolidinedione (i.e. Avandia or Actos) as a second drug therapy for patients who are not at glycemic goal on metformin alone. Galvus, like Januvia, is a DPP-4 inhibitor.

Inhaled Insulins on the Horizon
(Lilly/Alkermes, AIR Insulin)
(Novo/Aradigm, AERx iDMS)
(Mannkind, Technosphere Insulin)

Exubera, the inhaled insulin system from Pfizer, can now be prescribed by endocrinologists and will soon to be available to primary care physicians as well. For the forward-looking patient, however, we thought we would highlight other inhaled insulins under development, all of which are expected to be available in the next few years. Mannkind's Technosphere Insulin is said to be faster-acting even than the current rapid-acting injected analogs Novolog and Humalog, while Lilly/Alkermes' AIR Insulin unit is supposed to be extremely small and discreet. Novo/Aradigm's AERx iDMS will have the most flexible dosing (in one-unit increments vs. the larger titration increments of the other inhaled insulins). The trials we list above are for type 1 patients, but all three devices are in phase 3 testing for type 2 patients as well – just do a search for the one you're interested in.

Targeting Inflammation Using Salsalate in Type 2 Diabetes (TINSAL-T2D)

This phase 2/3 study will evaluate the efficacy of high-dose salsalate in treating type 2 diabetes. Salsalate, a variation of aspirin, is a member of the non-steroidal anti-inflammatory drug (NSAID) class commonly used to treat aches and pains (ibuprofen is another commonly-known NSAID). Current research suggests that chronic low-grade inflammation contributes to insulin resistance and type 2 diabetes, and several smaller studies have confirmed that treating diabetes patients with high-dose anti-inflammatory agents reduces their blood glucose. This trial will test this treatment in a larger population of 400 patients.