Hypoglycaemia data were collected during a Phase II clinical study comparing LY2605541 with insulin glargine in patients with type 2 diabetes. In addition to the reduction in nocturnal hypoglycaemia in LY2605541-treated patients, results showed the treatments had similar overall rates of hypoglycaemia (p=0.08, not statistically significant).1
The study used a validated patient-experience questionnaire called the
The results of this study found:
"As we continue development of our investigational novel basal insulin, we wanted to understand both the impact of the fear of hypoglycaemia and the impact of hypoglycaemic events and the emotional toll for the person with diabetes," said
About the Phase II Study1
The Phase II, randomized, open-label, parallel study evaluated LY2605541 in lowering self-monitored fasting blood glucose levels compared to insulin glargine in adults with type 2 diabetes. Patients were converted to morning insulin administration during a four-week lead-in period and were randomized 2:1 to morning administration of LY2605541 (195 patients) or glargine (93 patients) for a total of 12 weeks.
The primary endpoint of the study showed that LY2605541 and glargine had similar effects on lowering average daily self-monitored fasting (before breakfast) glucose levels (p=0 .433) and HbA1c (p=0.279) over 12 weeks.
Following treatment with LY2605541, blood tests on liver function (as measured by mean ALT and AST levels) statistically significantly increased from baseline and were higher than with insulin glargine. The mean levels of both liver enzymes remained within the normal range during the study for glargine and LY2605541-treated patients.
In the Phase II type 2 diabetes study, triglyceride levels in patients treated with LY2605541 were not significantly different from baseline (163 mg/dL to 172 mg/dL), but statistically higher compared to insulin glargine (160 mg/dL vs. 147 mg/dL). There was no significant difference in LDL-C or HDL-C in patients treated with LY2605541 from baseline or compared with insulin glargine.
Patients also completed the
An estimated 366 million people4 worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.5
Boehringer Ingelheim and
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim,
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavours.
In 2011, Boehringer Ingelheim achieved net sales of about
For more information please visit www.boehringer-ingelheim.com.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and our continued commitment to providing real solutions — from medicines to support programs and more — to make lives better.
For more information, visit www.lillydiabetes.com.
This press release contains forward-looking statements that are based on Lilly's current expectations for LY2605541(novel basal insulin), but actual results may differ materially due to various factors. There are significant risks and uncertainties in pharmaceutical research and development. There can be no guarantee that novel basal insulin will receive the necessary clinical and manufacturing regulatory approvals or that it will prove to be commercially successful. In addition, there can be no guarantee that the companies will realize the financial and commercial results anticipated from this collaboration. Other risk factors that may affect Lilly's results can be found in the company's latest Forms 10-K and 10-Q filed with the
*LY2605541 is an investigational agent. Its efficacy and safety have not been finally established.
1. Bergenstal RM, Rosenstock J, Arakaki RF, Prince MJ, Qu Y, Sinha VP, Howey DC, Jacober SJ. Weight loss and lower nocturnal hypoglycaemia with novel long-acting basal insulin LY2605541 versus insulin glargine in patients with type 2 diabetes. EASD: 48th Annual Meeting;
2. Curtis, B, Shi,
3. Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care 1987, 10:617-621.
4. International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2011.
5. International Diabetes Federation. Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on:
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