Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION).

AIMS: To assess the efficacy and safety of adjunctive saxagliptin vs glimepiride in elderly patients with type 2 diabetes (T2D) and inadequate glycaemic control. METHODS: In this multinational, randomized, double-blind, phase IIIb/IV study (GENERATION; NCT01006603), patients aged ≥65 years were randomized (1 : 1) to receive saxagliptin 5 mg/day or glimepiride ≤6 mg/day, added to metformin, during a 52-week treatment period. The primary endpoint was achievement of glycated haemoglobin (HbA1c) <7.0% at week 52 without confirmed/severe hypoglycaemia. The key secondary endpoint was incidence of confirmed/severe hypoglycaemia. Safety and tolerability were also assessed. RESULTS: Of 720 patients randomized (360 in each treatment group; mean age 72.6 years; mean T2D duration 7.6 years), 574 (79.8%) completed the study (saxagliptin 80.3%; glimepiride 79.2%). Similar proportions of patients achieved the primary endpoint with saxagliptin and glimepiride (37.9 vs 38.2%; odds ratio 0.99, 95% confidence interval 0.73, 1.34; p = 0.9415); however, a significant treatment-by-age interaction effect was detected (p = 0.0389): saxagliptin was numerically (but not significantly) superior to glimepiride for patients aged <75 years (39.2 vs 33.3%) and numerically inferior for patients aged ≥75 years (35.9 vs 45.5%). The incidence of confirmed/severe hypoglycaemia was lower with saxagliptin vs glimepiride (1.1 vs 15.3%; nominal p < 0.0001). Saxagliptin was generally well tolerated, with similar incidences of adverse events compared with glimepiride. CONCLUSION: As avoiding hypoglycaemia is a key clinical objective in elderly patients, saxagliptin is a suitable alternative to glimepiride in patients with T2D aged ≥65 years.

Avoidance of weight gain is important for oral type 2 diabetes treatments in Sweden and Germany: patient preferences.

AIMS: The aim of the study was to quantify patient preferences for outcomes associated with oral antidiabetic medications (OAMs) in Sweden and Germany through a discrete-choice experiment. METHODS: Adults taking OAMs who had a self-reported physician's diagnosis of type 2 diabetes mellitus (T2DM) made a series of nine choices between pairs of hypothetical profiles. Each profile had a predefined range of attributes: blood glucose control, frequency of mild-to-moderate hypoglycaemia, annual severe hypoglycaemic events, annual weight gain, pill burden and frequency of administration, and cost. Choice questions were based on an experimental design with known statistical properties. Bivariate probit analysis estimated the probabilities of choice of medication administration from patient characteristics and, conditional on that choice, preferences for treatment outcomes. RESULTS: The final sample consisted of 188 Swedish and 195 German patients. For both countries, weight gain was the most important attribute, followed by blood glucose control. Avoiding a 5-kg weight gain was 1.5 times more important in Sweden and 2.3 times more important in Germany than achieving moderate blood glucose control, thereby, suggesting that blood glucose control is relatively more important to Swedish than to German patients. Least important outcomes were the number of daily pills (Sweden) and frequency of mild-to-moderate hypoglycaemia (Germany). CONCLUSION: Patients in both Sweden and Germany preferred OAMs not associated with weight gain.