{"id":36744,"date":"2014-09-22T12:56:48","date_gmt":"2014-09-22T16:56:48","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=36744"},"modified":"2015-12-30T05:34:52","modified_gmt":"2015-12-30T10:34:52","slug":"fda-approves-trulicity-once-weekly-injection-for-type-2-diabetes","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=36744","title":{"rendered":"FDA Approves Trulicity, Once-Weekly Injection for Type 2 Diabetes"},"content":{"rendered":"

\"\"<\/a>On Thursday the United States Food and Drug Administration approved Trulicity, by Eli Lilly and Company, a once weekly, injectable GLP-1 treatment for adults with Type 2 diabetes.<\/p>\n

\u201cWe are delighted with the approval of Trulicity,\u201d the President of Lilly Diabetes Enrique Conterno said in a\u00a0statement<\/a>. \u201cLilly now has treatment options in several classes of diabetes medications: orals, GLPs and insulin. Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with Type 2 diabetes.\u201d<\/p>\n

GLP-1\u2014short for glucagon-like peptide-1 receptor agonists\u2014is a naturally occurring hormone released in the intestine that stimulates the release of insulin from pancreatic beta cells when carbohydrates are absorbed in the intestine. Additionally, GLP-1 is also present in the brain, where it acts as an appetite suppressant.<\/p>\n

Trulicity, which is the brand name for the drug dulaglutide, will be available later this year as an injectable treatment with a single-use pen that doesn\u2019t require mixing, or a needle attachment, the company said. It can be administered once a week, at any time of the day, regardless of mealtimes. Lilly recommends injecting Trulicity in the abdomen, the leg, or the upper arm.<\/p>\n

Dr. Sherry Martin, a senior medical director at Lilly who was involved in clinical trials for Trulicity, conceded that for Type 2 diabetics now treating their condition with oral medication, using an injectable drug could be a daunting change because it \u201ccarries with it an increased burden of responsibility.\u201d But, she said, when patients were ready to transition to an injectable treatment, she believed Trulicity would prove a more appealing option than the once daily regime of Victoza, another GLP-1 injectable that is the most popular treatment of its kind.<\/p>\n

The FDA cautioned that Trulicity<\/a>\u00a0\u201cshould not be used to treat people with Type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); those with severe stomach or intestinal problems; or as first-line therapy for [Type 2 diabetes] patients who cannot be managed with diet and exercise.\u201d<\/p>\n

Martin said that the treatment has been in development for 10 years. This included multiple clinical trials over the last five years. According to both Martin and the FDA, Trulicity was tested in six clinical trials that evaluated 3,342 subjects with Type 2 diabetes who were given Trulicity. The treatment was tested as a stand-alone drug, as well as being used alongside existing treatments, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. The results revealed that, according to the FDA, \u201cPatients receiving Trulicity had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control)\u201d compared to using such treatments on their own.<\/p>\n

Even though Trulicity has already undergone intensive rounds of testing, there is yet more testing that will follow. After the drug reaches the market, as part of its approval, the FDA said in\u00a0a statement<\/a>\u00a0that the agency is \u201crequiring the following post-marketing studies for Trulicity:\u00a0<\/p>\n