Main Category: Diabetes
Also Included In: Pharma Industry / Biotech Industry
Article Date: 13 Dec 2011 - 9:00 PST
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Boehringer Ingelheim and Eli Lilly and Company announced their results of a 24-week open label arm of a phase III study for linagliptin in initial combination with metformin at the International Diabetes Federation (IDF) World Diabetes Congress in Dubai. The results showed important reductions in blood glucose for adults with Type 2 Diabetes (T2D).
After 24 weeks the study demonstrated that poorly controlled patients who received the initial combination therapy of linagliptin with metformin achieved an average HbA1c reduction of -3.7%. According to the researchers the treatment was well tolerated. 9% of patients suffered drug-related adverse events (AEs) and just 1.5% developed hypoglycemia.
Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim said:
"Many patients with high HbA1c levels require more than metformin alone to reach their blood glucose targets. Linagliptin can support patients with Type 2 Diabetes to effectively manage their condition in order reach their blood glucose targets."
Linagliptin displayed robust improvements in glycemic control. The risk of adverse events in a 34-week extension phase of a one-year monotherapy trial was low. Scientists compared linagliptin to glimepiride in T2D patients' intolerant or developing contraindications to metforim. The researchers observed that linagliptin patients showed stable HbA1c levels at 7.5% at week 18 to 7.4% at week 52.
Patients switched from placebo after completing the earlier 18-week part of the trial showed comparable stable efficacy with glimepiride, however, those in the linagliptin group experienced a lower overall number of AEs. In comparison with glimepiride, drug-related AEs were lower with linagliptin, i.e. 7.8% vs. 4.4%, whilst hypoglycemia was observed to be statistically significant three times less (2.2%) with linagliptin compared with glimepiride (7.8%).
The researchers observed no severe episodes in either group. They also observed that patients' weight in the linagliptin group had remained stable, whilst patients in the glimepiride group showed a statistically significant weight increase from 82.5kg to 85 kg.
Linagliptin, known under the trade name Tradjenta™ in the US and Trajenta™ in Europe and other global markets, is the only approved diabetes treatment without the need for dose adjustment that is available at one dosage strength (5 mg, once daily) for all adult patients with T2D. Linagliptin works different compared with other DPP-4 inhibitors because its excretion is primarily unmetabolized via bile and gut, which means that for patients with declining kidney or liver function dose adjustments is unnecessary.
The researchers also established that linagliptins' promising cardiovascular (CV) profile was supported in an analysis consisting of 8 global phase III trials. The primary endpoint was a combination of CV death, nonfatal myocardial infarction, nonfatal stroke and hospitalization for unstable angina. The combined results showed a 69% reduction of the primary endpoint for linagliptin patients with the highest baseline Framingham risk score compared with respective comparators. Linagliptin's CV safety profile is currently evaluated in a 6,000 patients CAROLINA trial (Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes).
Robert Heine, M.D., Vice President of Medical Affairs at Lilly Diabetes explained:
"The CAROLINA trial has a unique design, in that it is the first CV outcome study in the DPP-4 class to include an active comparator. It is part of our joint long-term commitment to evaluate the effectiveness of our treatments and will add to the body of knowledge that physicians have to assist them in choosing the most appropriate treatment for their patients."
Writen by Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our diabetes section for the latest news on this subject. ”Initial combination of the DPP-4 inhibitor linagliptin with metformin improves poor glycaemic status in patients with Type 2 Diabetes” Abstract-O-0617
”1yr linagliptin monotherapy is well tolerated & sustains improvement in glycaemic control in patients for whom metformin is inappropriate” Abstract-D-0920
”Cardiovascular risk with linagliptin in subgroups of patients with Type 2 Diabetes: Results of a predefined meta-analysis” Abstract-P1349
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