The U.S. Food and Drug Administration (FDA) has approved the first outpatient artificial pancreas trial in the United States, marking a critical development in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with type 1 diabetes.   The JDRF-funded study will test an artificial pancreas system’s ability to function outside of a hospital setting, and is similar to the current outpatient trials being conducted in Europe.     The study is part of the first outpatient trials...

The FDA has approved Merck’s (MSD) new type 2 diabetes medication, JANUMET(R) XR (sitagliptin and metformin hydrochloride (HCl) extended-release) The new treatment combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.  Janumet targets three key defects of diabetes: insulin deficiency from pancreatic beta cells, insulin resistance, and overproduction of glucose by the liver. Janumet is indicated as an adjunct to diet and exercise to improve glycemic control in adults...

The FDA has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults submitted by Bristol-Myers Squibb Company and AstraZeneca. The complete response letter issued by the FDA follows the recommendations of the The U.S. FDA Endocrinologic and Metabolic Drugs Advisory Committee which voted against the drug, in July 2011, saying that the efficacy and safety data do not provide substantial evidence to support approval of dapagliflozin...

The U.S. Food and Drug Administration (FDA) issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes. This step comes after a large campaign led by the Juvenile Diabetes research Foundation (JDRF) pushing the FDA to set reasonable guidelines for the development of the artificial pancreas. JDRF’s campaign included a petition signed by 110,000 diabetes advocates asking the FDA to issue draft guidance by December 1, as...

The U.S. Food and Drug Administration (FDA) granted PositiveID Corporation clearance for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective...

The U.S. Food and Drug Administration (FDA) has granted Tandem Diabetes Care clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.   The t:slim has a color touch screen and was designed to make diabetes management easier to teach and easier to learn. Additional user-oriented...

The U.S. Food and Drug Administration (FDA) has  given Medtronic approval of its Investigational Device Exemption (IDE) to conduct a pivotal in-home clinical trial protocol for the ASPIRE (Automation to Simulate Pancreatic InsulinREsponse) study of the MiniMed Paradigm® System featuring Low Glucose Suspend (LGS) automation. FDA approval of the IDE makes Medtronic’s ASPIRE study the first in-home pivotal trial of a closed loop system for type 1 diabetes management.  This is the second phase of the ASPIRE study, following...

The U.S. Food and Drug Administration (FDA) has approved a new use for Amylin and Eli Lilly’s type 2 diabetes drug, Byetta (exenatide) injection.  Byetta is now approved as an add-on therapy to insulin glargine (Lantus), with or without metformin and/or a thiazolidinedione (TZD), for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone. The FDA approved Byetta as an add-on therapy to Lantus following a clinical trial where patients using Byetta with insulin glargine achieved...

ALR Technologies Inc received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Health-e-Connect (HeC) System for remote monitoring of patients in support of effective diabetes management programs. The 510(k) clearance enables the company to commence with the United States marketing and sales launch of its HeC platform.   The ALRT Health-e-Connect (HeC) System is a web-based patient management platform for medical professionals to improve compliance and management of care plans of patients in their homes....

Novo Nordisk filed two new drug applications for the approval of ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart (DegludecPlus) by the U.S. Food and Drug Administration. These new insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes. As with the European applications submitted on September 26, the U.S. filings are based on results from the BEGIN™ and BOOST™ clinical trial programs, which involved nearly 10,000 type 1 and type 2 diabetes patients....