Boehringer Ingelheim has reported positive data from a subgroup analysis of the CARMELINA clinical trial of linagliptin in type 2 diabetes patients.
Results showed that the drug did not increase the risk of adverse cardiovascular (CV) events or hypoglycaemia when compared to placebo.
Linagliptin is a once-daily DPP-4 inhibitor that demonstrated efficacy in decreasing blood sugar levels in adults with type 2 diabetes. Boehringer is working with Eli Lilly and Company Alliance to develop and commercialise the drug.
The multi-national, randomised, double-blind, placebo-controlled CARMELINA study enrolled 6,979 patients at more than 600 sites in 27 countries. It involved a median observation period of 2.2 years.
This cardiovascular outcome trial involved participants aged 18 years and older with high cardiovascular risk. The prespecified subgroup analysis explored clinical outcomes and adverse events in patients aged under 65, 65 to 75, and over 75.
Compared to placebo, linagliptin did not raise the risk of cardiovascular events, adverse kidney outcomes, or hospitalisation for heart failure across the age groups.
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The drug also improved glycaemic control in all age groups versus placebo. An increase in the incidence of adverse events with age was observed, but the increase was similar in the linagliptin and placebo arms.
Boehringer Ingelheim corporate vice-president and CardioMetabolic Medicine head Waheed Jamal said: “Their advanced age, combined with established cardiovascular and/or kidney disease, means the older population of Carmelina was comprised of high-risk individuals with type 2 diabetes.
“The results should reassure healthcare professionals that linagliptin is suitable for a wide patient population to improve glycaemic control whilst ensuring cardiovascular and renal safety.”
In February last year, linagliptin demonstrated an encouraging profile in the CAROLINA cardiovascular outcomes trial in type 2 diabetes patients.