First patient enrolled in new cardiovascular and renal outcomes trial for linagliptin in Type 2 Diabetes

Linagliptin (5 mg, once daily) is a once-daily tablet that is used along with diet and exercise and other drug therapies to improve glycaemic control in adults with Type 2 Diabetes.

“Diabetes is a major risk factor for cardiovascular disease, as well as a leading cause of chronic renal failure,” said Dr. Julio Rosenstock, Director of the Dallas Diabetes and Endocrine Center at Medical City in Dallas and Principal Investigator of the study. “CARMELINA will investigate both cardiovascular and renal safety with a DPP-4 inhibitor on adverse cardiovascular and renal outcomes.”

The CARMELINA study will include more than 8,000 adults with Type 2 Diabetes in 24 countries at more than 500 sites around the world.¹ The primary endpoint will be time to the first occurrence of either CV death (including fatal stroke and fatal MI); non-fatal MI; non-fatal stroke; or hospitalisation for unstable angina pectoris (AP). The renal outcome is measured as a composite of renal death, sustained end-stage renal disease and sustained decrease of ≥50 percent eGFR.1 The study is expected to complete in 2018.

“We are delighted that the first patient has now been enrolled in CARMELINA and look forward to continued recruitment and patient follow-up,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The initiation of this trial reinforces our ongoing commitment to evaluate the efficacy and safety of linagliptin, ensuring that treating physicians are provided with all required information to support the use of the treatment in clinical practice as appropriate.”

About CARMELINA

CARMELINA (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with Type 2 Diabetes mellitus at high vascular risk) is a long-term study investigating the efficacy and safety of linagliptin 5 mg once daily versus placebo on cardiovascular and renal microvascular outcomes in people with Type 2 Diabetes who are at risk of cardiovascular events. Adults with Type 2 Diabetes and previous CV complications and albuminuria (UACR ≥30mg/g) and/or evidence of microvascular related end-organ damage (eGFR 15-200mg/g) will be randomised into the study.

About Linagliptin

Linagliptin is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin tablets), as a once-daily tablet (5mg) that is used along with diet and exercise to improve glycaemic control in adults with Type 2 Diabetes. Linagliptin should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).^2,3

About Diabetes

An estimated 371 million people worldwide have Type 1 and Type 2 Diabetes.⁴ Type 2 Diabetes is the most common type, accounting for an estimated 90 percent of all diabetes cases.⁵ Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.⁶

References

1. Clinical Trials: CARMELINA: CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with Type 2 Diabetes mellitus at high cardiovascular risk
2. Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011
3. EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011
4. International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update – 5th Edition). 2012.
5. World Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited 2013 January 2013]; Available from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html#
6. International Diabetes Federation. What is Diabetes IDF Diabetes Atlas. 2011; (5th Edition).