Significant hypoglycemic weight loss, Lilly Diabetes New Drug Phase 3 results positive

Significant hypoglycemic weight loss, Lilly Diabetes New Drug Phase 3 results positive

February 27, 2018 Source: WuXi PharmaTech

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Eli Lilly and Company today announced the positive results of a new Phase 3b clinical study. The new type 2 diabetes drug, Turicity (dulaglutide), significantly improved the mean blood glucose concentration (A1C) for patients over 2 to 3 months when added to the treatment of sodium-glucose cotransporter-2 (SGLT-2) inhibitors. The study, called AWARD-10, was recently published in the journal The Lancet Diabetes & Endocrinology.

About 425 million adults worldwide have diabetes, and there are nearly 30 million patients in the United States alone. Type 2 diabetes is the most common type of diabetes in the world, accounting for 90% to 95% of the total number of cases of diabetes in the United States. Diabetes is a chronic condition in which the patient's body cannot produce or use insulin properly.

Trulicity is an Lilly Glucagon-like peptide-1 (GLP-1) receptor agonist from Lilly. This weekly injection is approved in the United States to improve blood sugar (glucose) in patients with type 2 diabetes.

AWARD-10 is a double-blind, parallel-group, placebo-controlled, 24-week Phase 3b clinical trial designed to study 1.5 mg or 0.75 mg of Tulipan and sodium-glucose cotransporter-2 (SGLT-2) inhibitors The security and effectiveness of the combination. These type 2 diabetic patients (whether or not taking metformin) were not adequately controlled with SGLT-2 inhibitors. The primary goal of this study was to demonstrate that Trulicity combined with SGLT-2 inhibitors in 424 patients in eight countries significantly reduced blood glucose levels in patients compared with placebo plus SGLT-2 inhibitors.

Studies have shown that at the primary endpoint at 24 weeks, the addition of 1.5 mg or 0.75 mg of Tulipan to patients receiving SGLT-2 inhibitors showed statistically significant glycemic control (-1.34% and -1.21% improvement in A1C, respectively). The placebo combined with the SGLT-2 inhibitor only improved -0.54%. In addition, significantly more patients in the Trolicity group achieved a target of less than 7% A1C and 6.5% or less (baseline 8.04%):

• 1.5 mg Truecity: 71% (<7%); 50% (≤ 6.5%)

• 0.75 mg Truecity: 60% (<7%); 38% (≤ 6.5%)

• Placebo: 32% (<7%); 14% (≤6.5%)

Other results showed that 1.5 mg of Tulipan combined with SGLT-2 inhibitor resulted in a greater mean weight loss (-3.1 kg) compared with placebo (-2.1 kg). The observation in the 0.75 mg Truecity group was -2.6 kg. The most common adverse events in Trulicity are associated with the gastrointestinal tract and are consistent with previous studies. No new security issues related to Trulicity were found.

â–²Trulicity's mechanism of action (Source:Trulicity official website)

“I have seen many patients with type 2 diabetes treated with effective oral medications such as SGLT-2 inhibitors and metformin, which require additional treatment to maintain blood sugar levels,” said Associate Professor of Medicine at Rudolfstiftung Hospital in Vienna and AWARD-10 Principal Investigator. Dr. Bernhard Ludvik said: "The results of the AWARD-10 study show that the combination of Trulicity and SGLT-2 inhibitors once a week shows great promise to help more patients with type 2 diabetes achieve their therapeutic goals."

“Given some patients with type 2 diabetes who are still on the diet after diet, exercise and oral medications, they may need to increase their injection therapy,” said Dr. Brad W. Woodward, Senior Medical Director of the Lilly Diabetes Department: “AWARD-10 indicates Trulicity, in combination with SGLT-2 inhibitors and metformin, may be effective and well tolerated in patients with type 2 diabetes."

We hope that this new drug will be available soon, helping more type 2 diabetic patients to effectively lose weight and lower blood sugar.

Reference materials:

[1] Diabetes Market Heats Up as Eli Lilly's Trulicity Combo Shows Improved Blood Sugar Control

[2] New Data Show Lilly's Trulicity (dulaglutide) in Combination with an SGLT-2 Inhibitor Improves Blood Sugar Control in People with Type 2 Diabetes

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