=Eli Lilly's (LLY) diabetes drug shows promise in mid-stage trial

• Peer: NVO

Oct 4 (Reuters) - Eli Lilly and Co said on Thursday data from mid-stage trial of its experimental diabetes drug showed clinically meaningful blood sugar reduction and weight loss in people with type 2 diabetes.

Data from the six-month study showed that the drug significantly reduced blood sugar levels by up to 2.4 percent and an average weight reduction of up to 12.7 percent, Lilly said in a statement.

The company said it intends to complete its late-stage study for the drug in late 2021, and is also evaluating the drug for treating obesity, among other conditions.

About 30 million adults in the United States have diabetes, with 90 to 95 percent of them suffering from type 2 diabetes, according to Lilly.

Lilly's wide portfolio of diabetes drugs, including Humalog and Trulicity, contributed at least 38 percent to its total sales of $6.36 billion in the last quarter. 

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Eli Lilly investigational dual GIP and GLP-1 receptor agonist shows significant reduction in HbA1c and body weight in people with type 2 diabetes  

• At 26 weeks, the primary analysis showed a robust dose response compared to placebo throughout the entire dose range of GIP/GLP-1 RA included in the study.
• The analysis of participants while on treatment comparing GIP/GLP-1 RA to dulaglutide and placebo showed significant improvements across endpoints.
• HbA1c reduction: All GIP/GLP-1 RA doses and dulaglutide showed significant blood sugar improvement (mean absolute reduction) from baseline [GIP/GLP-1 RA: -1.6% (5 mg), -2.0% (10 mg), and -2.4% (15 mg); dulaglutide -1.1% (1.5 mg)] compared to placebo (0.1%).
• The safety and efficacy of Lilly's GIP/GLP-1 RA are being studied further in a large phase 3 clinical program that will be referred to as the SURPASS program. Phase 3 studies for type 2 diabetes are expected to begin no later than early 2019 and complete in late 2021. Lilly is evaluating next steps in the study of GIP/GLP-1 RA for obesity and other conditions.

Eli Lilly announces that empagliflozin met the primary efficacy endpoint for all doses investigated (2.5, 10 and 25 mg) in the Empagliflozin as Adjunctive to inSulin thErapy Phase III program in adults with type 1 diabetes 

In EASE-2, placebo-corrected mean change from baseline in A1C at week 26 was -0.54 percent and -0.53 percent for empagliflozin 10 and 25 mg, respectively. In EASE-3, placebo-corrected mean change from baseline in A1C at week 26 was -0.28 percent, -0.45 percent and -0.52 percent for empagliflozin 2.5 mg, 10 mg and 25 mg, respectively. In addition to reduction in A1C, empagliflozin treatment was effective on secondary endpoints, showing reductions in weight, decreases in blood pressure, and decreases in total daily insulin dose. In addition, data from continuous glucose monitoring in the EASE program indicates that patients treated with empagliflozin had improved glycemic variability and spent more time in range, although the data for the 2.5 mg dose are limited.

• Based on the totality of the EASE data, partner Boehringer Ingelheim has initiated regulatory discussions for empagliflozin as adjunct to insulin for adults with type 1 diabetes.