Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial

Roden, Michael; Weng, Jianping; Eilbracht, Jens; Delafont, Bruno; Kim, Gabriel; Woerle, Hans J.; Broedl, Uli C.

doi:10.1016/s2213-8587(13)70084-6

Cited by 396 publications

(440 citation statements)

References 16 publications

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“…Empagliflozin has consistently been shown to lead to sustained weight loss in patients with type 2 diabetes 13, 14, 15, 16, 17, 18, including those treated with a regimen of multiple daily injections of insulin, likely due to loss of calories in the urine. The majority of weight loss in patients with type 2 diabetes is attributable to a reduction in fat mass, including reductions in both trunk fat and limb fat and in both abdominal visceral and abdominal subcutaneous adipose tissue 23.…”

Section: Discussionmentioning

confidence: 99%

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Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4‐week, randomized, placebo‐controlled trial (EASE‐1)

Pieber

Famulla

Eilbracht

et al. 2015

Diabetes Obesity Metabolism

158

165

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AimsTo investigate the pharmacodynamics, efficacy and safety of empagliflozin as adjunct to insulin in patients with type 1 diabetes.MethodsA total of 75 patients with glycated haemoglobin (HbA1c) concentrations of ≥7.5 to ≤10.5% (≥58 to ≤91 mmol/mol) were randomized to receive once‐daily empagliflozin 2.5 mg, empagliflozin 10 mg, empagliflozin 25 mg, or placebo as adjunct to insulin for 28 days. Insulin dose was to be kept as stable as possible for 7 days then adjusted, at the investigator's discretion, to achieve optimum glycaemic control. The primary exploratory endpoint was change from baseline in 24‐h urinary glucose excretion (UGE) on day 7.ResultsEmpagliflozin significantly increased 24‐h UGE versus placebo on days 7 and 28. On day 28, adjusted mean differences with empagliflozin versus placebo in changes from baseline in: HbA1c were −0.35 to −0.49% (−3.8 to −5.4 mmol/mol; all p < 0.05 vs. placebo); total daily insulin dose −0.07 to −0.09 U/kg (all p<0.05 vs placebo); and weight were −1.5 to −1.9 kg (all p < 0.001 vs. placebo). In the placebo, empagliflozin 2.5, 10 and 25 mg groups, respectively, adverse events were reported in 94.7, 89.5, 78.9 and 100.0% of patients, and the rate of symptomatic hypoglycaemic episodes with glucose ≤3.0 mmol/l not requiring assistance was 1.0, 0.4, 0.5 and 0.8 episodes per 30 days.ConclusionsIn patients with type 1 diabetes, empagliflozin for 28 days as adjunct to insulin increased UGE, improved HbA1c and reduced weight with lower insulin doses compared with placebo and without increasing hypoglycaemia.

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Section: Discussionmentioning

confidence: 99%

“…In patients with type 2 diabetes, empagliflozin given as monotherapy or as add‐on therapy (including as add‐on to basal insulin or multiple daily injections of insulin) has consistently been shown to improve glycaemic control and reduce blood pressure and weight, with a low risk of hypoglycaemia 13, 14, 15, 16, 17, 18.…”

Section: Introductionmentioning

confidence: 99%

Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4‐week, randomized, placebo‐controlled trial (EASE‐1)

Pieber

Famulla

Eilbracht

et al. 2015

Diabetes Obesity Metabolism

158

165

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“…Eine moderate Reduktion des systoli schen Blutdrucks † beruht wohl auf der mit der Glukosurie verbundenen milden Diurese, die unabhängig von der Begleit medikation erfolgt [7,[9][10][11][12]. Das Aus maß der Blutdrucksenkung unter Empa gliflozin ist dabei abhängig vom Ausgangswert.…”

Section: Forum Der Industrieunclassified

SGLT2-Inhibitoren – Effektive Blutzuckerregulation über die Niere

2014

Diabetes aktuell

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“…They showed that SGLT-2 inhibitors produce similar glucose-lowering effects as metformin and sulphonylureas, with a slightly greater weight loss compared with metformin and a weight reduction (instead of a weight gain) and less hypoglycaemia compared with sulphonylureas 3 . In most trials comparing a SGLT-2 inhibitor with a DPP-4 inhibitor (including Roden's study) 4 , the active comparator was used in an exploratory…”

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confidence: 99%

“…Roden' study was the only trial comparing a SGLT-2 with a gliptin in drug-naive patients 4 while two other studies compared empagliflozin 7 or canagliflozin 8 with sitagliptin in metformin-treated patients, and one (about canagliflozin) in patients already receiving a dual therapy metformin-sulphonylurea 9 . Compared with sitagliptin 100 mg, all clinical trials performed with empagliflozin or canagliflozin (no such comparative trial available with dapagliflozin) showed a similar (or slightly) greater reduction in HbA1c, a greater fall in fasting plasma glucose, a significant weight loss of 2 to 3 kg (versus weight neutrality with sitagliptin) and a reduction in systolic blood pressure (especially with the higher dose of the SGLT-2 inhibitor) ( Table 1).…”

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confidence: 99%

SGLT2 versus DPP4 inhibitors for type 2 diabetes

Scheen

2013

The Lancet Diabetes & Endocrinology

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Management of hyperglycaemia in type 2 diabetes (T2DM) remains challenging despite increasing pharmacological opportunities 1 . The old drug metformin remains the first-line therapy in all guidelines. However, a significant number of patients cannot tolerate the biguanide because of gastrointestinal adverse events or may have contraindications to its use. Which drug to be prescribed to those patients or to those not well controlled with metformin monotherapy is still controversial. Advantages and disadvantages of specific glucose-lowering drugs for each patient should be considered 1 . Dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins) offer some advantages over classical sulphonylureas (no weight gain, no hypoglycaemia), but are more expensive 2 . A new class of glucose-lowering therapies is emerging with the recent launch of two inhibitors of sodium-glucose cotransporters type 2 (SGLT-2) (dapagliflozin and canagliflozin), and the expected commercialisation of a third one, empagliflozin, in a near future. These agents

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Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial

Cited by 396 publications

References 16 publications

Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4‐week, randomized, placebo‐controlled trial (EASE‐1)

Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4‐week, randomized, placebo‐controlled trial (EASE‐1)

SGLT2-Inhibitoren – Effektive Blutzuckerregulation über die Niere

SGLT2 versus DPP4 inhibitors for type 2 diabetes

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