Taspoglutide, a once‐weekly glucagon‐like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open‐label randomized trial. Issue 1 (13th December 2012)

• Record Type: Journal Article
• Authors: Nauck, M.; Horton, E.; Andjelkovic, M.; Ampudia‐Blasco, F. J.; Parusel, C. T.; Boldrin, M.; Balena, R.
• Is Part Of: Diabetic medicine. Volume 30:Issue 1(2013:Jan.)
• Page Start: 109
• Page End: 113
• Publication Date: 2012-12-13
• Subjects: Diabetes -- Periodicals; 616.462
• DOI: 10.1111/dme.12003
• Languages: English
• ISSNs: 0742-3071

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <p> <bold>Aims </bold> To compare the efficacy and safety of once‐weekly taspoglutide with insulin glargine in patients with advanced Type 2 diabetes failing metformin and sulphonylurea combination therapy.</p> <p> <bold>Methods </bold> This open‐label, parallel‐group, multi‐centre trial randomized 1049 patients continuing metformin 1:1:1 to taspoglutide 10 mg once weekly, taspoglutide 20 mg once weekly or insulin glargine once daily with forced titration to fasting plasma glucose ≤ 6.1 mmol/l. Sulphonylureas were discontinued before randomization. The primary endpoint was change in HbA<sub>1c</sub> after 24 weeks.</p> <p> <bold>Results </bold> After 24 weeks, least‐square mean changes from baseline in HbA<sub>1c</sub> in patients receiving taspoglutide 10 mg [−8 mmol/mol (<sc>se</sc> 1)] [−0.77% (<sc>se</sc> 0.05)] or taspoglutide 20 mg [−11 mmol/mol (<sc>se</sc> 1)] [−0.98% (<sc>se</sc> 0.05)] were non‐inferior to insulin glargine [−9 mmol/mol (<sc>se</sc> 1)] [−0.84% (<sc>se</sc> 0.05)]; treatment difference of 0.07% (95% CI −0.06 to 0.21) and −0.14% (95% CI −0.28 to −0.01), for taspoglutide 10 and 20 mg, respectively, vs. insulin glargine. Taspoglutide was associated with more adverse events (mainly gastrointestinal) and significantly less hypoglycaemia than insulin glargine.</p> <p> <bold>Conclusions </bold> Compared with insulin glargine, taspoglutide provided non‐inferior HbA<sub>1c</sub> reductions associated with less hypoglycaemia, but more gastrointestinal adverse events.</p> </abstract>