The results from a new study in which Linagliptin ( Tradjenta ), a DPP-4 inhibitor, has demonstrated statistically significant reductions in blood glucose levels ( HbA1c ) after 12 weeks ( primary endpoint ) in adults with type 2 diabetes ( T2D ) with moderate to severe renal impairment, compared with placebo, were presented at the American Diabetes Association ( ADA ) 73rd Scientific Sessions.
Most patients had type 2 diabetes mellitus for more than ten years ( 76% ) and were on Insulin ( 86% ).
Over an extension period ( week 12 to week 52 ), patients treated with Linagliptin had an overall improvement in blood glucose levels that was similar to those patients who had initially received placebo for 12 weeks and were thereafter switched to Glimepiride for the remaining 40 weeks. Patients treated with Linagliptin had a lower rate of hypoglycemia compared to those treated with Glimepiride.
These new findings were derived from a double-blinded trial including 235 people with type 2 diabetes and moderate to severe renal impairment ( estimated glomerular filtration rate less than 60 mL/min/1.73m2 ).
For analysis of the primary endpoint, patients were randomized to Linagliptin, 5 mg once daily ( n=113 ) or placebo ( n=122 ) for 12 weeks.
For the 40-week extension period, patients initially randomized to placebo were switched to Glimepiride 1-4 mg once daily and treatment continued in both groups to week 52 ( n=107, Linagliptin 5 mg and n=114, Glimepiride 1-4 mg ).
The primary endpoint was the reduction in HbA1c levels from baseline at 12 weeks. Mean HbA1c levels at baseline were 8.08% for the Linagliptin group and 8.03% for the placebo / Glimepiride group.
Key results from the study showed:
Greater mean reduction from baseline HbA1c at 12 weeks for patients treated with Linagliptin vs placebo ( -0.53% vs. -0.11%, respectively; treatment difference -0.42%, p less than 0.0001 );
In the 40-week extension, the change in mean HbA1c was similar for Linagliptin and Glimepiride;
Over the extension period, there was less hypoglycemia with Linagliptin vs Glimepiride-treated patients ( 57.9% vs 69.3% ). ( Xagena )
Source: Lilly, 2013