Oral glucose lowering with linagliptin and metformin compared with linagliptin alone as initial treatment in Asian patients with newly diagnosed type 2 diabetes and marked hyperglycemia: Subgroup analysis of a randomized clinical trial |
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| Authors: | Ronald CW Ma Stefano Del Prato Baptist Gallwitz Vyankatesh K Shivane Diane Lewis‐D'Agostino Zelie Bailes Sanjay Patel Jisoo Lee Maximilian von Eynatten Maximiliano Di Domenico Stuart A Ross |
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| Affiliation: | 1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China;2. Section of Diabetes, Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy;3. Department of Medicine IV, University Hospital Tübingen, Tübingen, Germany;4. Department of Endocrinology, Seth G. S. Medical College and KEM Hospital, Mumbai, India;5. Boehringer Ingelheim Pharmaceuticals Inc., Connecticut, USA;6. Boehringer Ingelheim Ltd, Bracknell, UK;7. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany;8. University of Calgary, LMC Endocrinology Centers, Alberta, Canada |
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| Abstract: | Aims/Introduction Type 2 diabetes mellitus is an epidemic in Asia, yet clinical trials of glucose‐lowering therapies often enroll predominantly Western populations. We explored the initial combination of metformin and linagliptin, a dipeptidyl peptidase‐4 inhibitor, in newly diagnosed type 2 diabetes mellitus patients in Asia with marked hyperglycemia. Materials and Methods This was a post‐hoc subgroup analysis of a multinational, parallel‐group clinical trial in which 316 newly diagnosed type 2 diabetes mellitus patients with glycated hemoglobin A1c (HbA1c) 8.5–12.0% were randomized to double‐blind oral treatment with linagliptin/metformin or linagliptin monotherapy. The primary end‐point was the change from baseline in HbA1c at week 24. We evaluated data for the 125 participants from Asian countries. Results After 24 weeks, the mean ± standard error reduction from baseline in HbA1c (mean 10.0%) was ?2.99 ± 0.18% with linagliptin/metformin and ?1.84 ± 0.18% with linagliptin; a treatment difference of ?1.15% (95% confidence interval ?1.65 to ?0.66, P < 0.0001). HbA1c <7.0% was achieved by 60% of participants receiving linagliptin/metformin. The mean bodyweight change after 24 weeks was ?0.45 ± 0.41 kg and 1.33 ± 0.45 kg in the linagliptin/metformin and linagliptin groups, respectively (treatment difference ?1.78 kg [95% confidence interval ?2.99 to ?0.57, P = 0.0043]). Drug‐related adverse events occurred in 9.7% of participants receiving linagliptin/metformin and 4.8% of those receiving linagliptin. Hypoglycemia occurred in 6.5% and 4.8% of the linagliptin/metformin and linagliptin groups, respectively, with no severe episodes. Gastrointestinal disorders occurred in 12.9% and 12.7% of the linagliptin/metformin and linagliptin groups, respectively, with no associated treatment discontinuations. Conclusions In people from Asia with newly diagnosed type 2 diabetes mellitus and marked hyperglycemia, the initial combination of linagliptin and metformin substantially improved glycemic control without weight gain and with infrequent hypoglycemia. Initial oral combination therapy might be a viable treatment for such individuals. |
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| Keywords: | Asia Diabetes mellitus type 2 Dipeptidyl peptidase‐4 inhibitors |
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