Empagliflozin improves glycaemic and weight control as add‐on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24‐week, randomized, placebo‐controlled trial. Issue 2 (22nd August 2013)

• Record Type: Journal Article
• Authors: Kovacs, C. S.; Seshiah, V.; Swallow, R.; Jones, R.; Rattunde, H.; Woerle, H. J.; Broedl, U. C.
• Is Part Of: Diabetes, obesity & metabolism. Volume 16:Issue 2(2014:Feb.)
• Page Start: 147
• Page End: 158
• Publication Date: 2013-08-22
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12188
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12188-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12188-sec-0001" sec-type="section"> <title>Aims</title> <p id="dom12188-para-0001">This study investigated the efficacy and tolerability of empagliflozin as add‐on to pioglitazone ± metformin in patients with type 2 diabetes (T2DM).</p> </sec> <sec id="dom12188-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12188-para-0002">Patients with HbA1c ≥7 and ≤10% were randomized and treated with once daily empagliflozin 10 mg (n = 165), empagliflozin 25 mg (n = 168) or placebo (n = 165) as add‐on to pioglitazone ± metformin for 24 weeks. Endpoints included changes from baseline in HbA1c (primary endpoint), fasting plasma glucose (FPG) and body weight at week 24.</p> </sec> <sec id="dom12188-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12188-para-0003">Adjusted mean ± standard error changes in HbA1c were −0.6 ± 0.07% and −0.7 ± 0.07% with empagliflozin 10 mg and 25 mg, respectively, vs. −0.1 ± 0.07% with placebo (both p < 0.001). More patients with HbA1c ≥7% at baseline achieved HbA1c <7% with empagliflozin 10 mg (23.8%) and 25 mg (30.0%) vs. placebo (7.7%) (both p < 0.001). FPG decreased with empagliflozin (−0.94 mmol/l for 10 mg and −1.22 mmol/l for 25 mg) and increased with placebo (+0.36 mmol/l; both p < 0.001). Adjusted mean ± standard error changes in weight were −1.62 ± 0.21 kg and −1.47 ± 0.21 kg with empagliflozin 10 mg and 25 mg, respectively, vs. +0.34 ± 0.21 kg with placebo (both p < 0.001). Similar proportions of patients reported adverse events with empagliflozin (67.3–71.4%) and placebo (72.7%). Confirmed hypoglycaemia was reported by 1.2–2.4% of patients on empagliflozin and 1.8% on placebo.</p> </sec> <sec id="dom12188-sec-0004" sec-type="section"> <title>Conclusion</title> <p id="dom12188-para-0004">Empagliflozin 10 mg and 25 mg once daily for 24 weeks as add‐on to pioglitazone ± metformin reduced HbA1c, FPG and weight and were well tolerated in patients with T2DM.</p> </sec> </abstract>