Efficacy and Safety of Linagliptin in Subjects With Long-standing Type 2 Diabetes Mellitus (>10 Years): Evidence From Pooled Data of Randomized, Double-blind, Placebo-controlled, Phase III Trials

Abstract

This pooled analysis found that linagliptin was well tolerated and significantly improved hyperglycemia in a clinically challenging population of patients with long-standing T2DM (>10 years). Although T2DM is commonly associated with diminished β-cell function, the extent of glucose lowering was similar to that in linagliptin trials, which largely included patients in earlier stages of the disease. Thus, this observation supports the hypothesis that regulation of glucagon release from pancreatic α cells may be of particular relevance for improving hyperglycemia in patients with long-term T2DM (NCT01194830 and NCT01084005).

Efficacy and safety of linagliptin as add‐on therapy to basal insulin and metformin in people with Type 2 diabetes

“…These findings may be particularly relevant to patients with long-standing Type 2 diabetes as such patients are more likely to use insulin in combination with background therapy. A pooled analysis of clinical trial data from participants with a Type 2 diabetes duration of >10 years showed that linagliptin was well tolerated and significantly improved hyperglycaemia [14]. The extent of glucose-lowering was similar to that observed in linagliptin trials that largely included participants in the earlier stages of Type 2 diabetes.…”

Octreotide for hypoglycemia caused by sulfonylurea and DPP-4 inhibitor

“…Strong insulin stimulatory action of combination therapy of sulfonylureas and DPP-4 inhibitors has been well recognized. Indeed, the increased rate of hypoglycemia with DPP-4 inhibitors and sulfonylureas has been reported [3]. In the early period after the release of DPP-4 inhibitors in Japan, there were reports of these agents causing severe hypoglycemia when combined with sulfonylureas.…”

Diabetes in Older People

“…DPP-4 inhibitors (alogliptin, linagliptin, saxagliptin and sitagliptin) are similarly effective and safe in young and older people with diabetes, cause minimal hypoglycemia when used alone (or with metformin) and do not result in weight gain (123)(124)(125)(126)(127)(128)(129)(130)(131)(132). Large numbers of older people have been enrolled in studies of these drugs, including those over 75 and with multiple comorbidities.…”