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Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes

Posted 18 days ago by Drugs.com

PARIS, Nov. 21, 2016 /PRNewswire-USNewswire/ – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide*. Soliqua 100/33 is the combination of Lantus (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection, studied in a Phase 3 program of more than 1,900 patients. In an insulin intensification study, Soliqua 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus with a majority of the 736 patients (55% vs. 30%) achieving the American Diabetes Association target of less than 7% at 30 weeks. Patients treated with Soliqua 100/33 experienced similar rates of documented ... Read more

Related support groups: Diabetes, Type 2, Lantus, Insulin Glargine, Soliqua, Adlyxin, Lixisenatide, Insulin Glargine/lixisenatide

Intensive Type 2 Diabetes Treatment Can Extend Survival: Study

Posted 8 Sep 2016 by Drugs.com

WEDNESDAY, Sept. 7, 2016 – Intensive management of type 2 diabetes can make a difference in how long and how well you live, even if you don't start until middle age, researchers report. People who were already at risk of type 2 diabetes complications were randomly selected to continue with their normal treatment or to be placed in an aggressive and multipronged treatment group. Two decades after the study began, the researchers found that people in the aggressive treatment group lived almost eight years longer. Not only that, they lived better – their risk of heart disease, kidney disease and blindness all dropped. The only complication that didn't seem to improve was nerve damage caused by diabetes. "Early, intensified intervention in type 2 diabetes patients with microalbuminuria with both target-driven pharmacological (medication) and behavioral actions increased life span. And, ... Read more

Related support groups: Diabetes, Type 2, Metformin, Insulin, Victoza, Lantus, Januvia, Glucophage, Novolog, Glipizide, Humalog, Janumet, Byetta, Glyburide, Saxenda, Bydureon, Lantus Solostar, Invokana, Levemir, Actos, Glimepiride

Adlyxin Approved for Type 2 Diabetes

Posted 1 Aug 2016 by Drugs.com

THURSDAY, July 28, 2016 – Adlyxin (lixisenatide) has been approved by the U.S. Food and Drug Administration to treat type 2 diabetes in adults, the agency said Thursday in a news release. As the FDA explained, Adlyxin is a "glucagon-like peptide-1 receptor agonist" – a hormonal drug that helps control blood sugar. The drug was evaluated in clinical studies involving 5,400 people with type 2 diabetes. A separate study was held involving 6,000 type 2 diabetics at risk for atherosclerotic cardiovascular disease, the FDA said. Type 2 diabetes affects more than 29 million people in the United States, accounting for about 90 percent of diagnosed cases of diabetes, the agency said. Elevated blood sugar caused by the disease can lead to complications including heart disease, blindness and nerve and kidney damage. The most common side effects of Adlyxin included nausea, vomiting, headache, ... Read more

Related support groups: Diabetes, Type 2, Adlyxin, Lixisenatide

FDA OKs New Injectable Type 2 Diabetes Medication

Posted 28 Jul 2016 by Drugs.com

THURSDAY, July 28, 2016 – The injectable drug Adlyxin (lixisenatide) has been approved to treat adults with type 2 diabetes, the U.S. Food and Drug Administration says. The once-daily injection is to be used along with diet and exercise to improve patients' blood sugar levels. The FDA reviewed 10 clinical trials on the safety and effectiveness of Adlyxin. These studies included 5,400 people with type 2 diabetes. The drug was also specifically tested for heart issues in an additional 6,000 people at risk of heart disease, the FDA said Thursday in a news release. The FDA concluded that Adlyxin helps normalize blood sugar levels. And it doesn't appear to increase the risk of heart problems. Adlyxin is in a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. Other GLP-1 drugs include liraglutide (Victoza), exenatide (Byetta, Bydureon) and dulaglutide (Trulicity), ... Read more

Related support groups: Diabetes, Type 2, Victoza, Insulin Resistance, Byetta, Saxenda, Bydureon, Pre-Diabetes, Trulicity, Liraglutide, Diabetes Mellitus, Exenatide, Abnormal Glucose Tolerance, Dulaglutide, Adlyxin, Lixisenatide

Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes

Posted 28 Jul 2016 by Drugs.com

PARIS, July 27, 2016 /PRNewswire/ – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. "The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled." The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which ... Read more

Related support groups: Diabetes, Type 2, Adlyxin, Lixisenatide

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Diabetes, Type 2

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Adlyxin

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