The DOI matches its Crossref record; 35 of the 35 references it cites were found in a registry or an index.
Safety and efficacy of linagliptin as add‐on therapy to metformin in patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled study
Abstract
Aim: To evaluate the efficacy and safety of the potent and selective dipeptidyl peptidase‐4 (DPP‐4) inhibitor linagliptin administered as add‐on therapy to metformin in patients with type 2 diabetes with inadequate glycaemic control. Methods: This 24‐week, randomized, placebo‐controlled, double‐blind, parallel‐group study was carried out in 82 centres in 10 countries. Patients with HbA1c levels of 7.0–10.0% on metformin and a maximum of one additional antidiabetes medication, which was discontinued at screening, continued on metformin ≥1500 mg/day for 6 weeks, including a placebo run‐in period of 2 weeks, before being randomized to linagliptin 5 mg once daily (n = 524) or placebo (n = 177) add‐on. The primary outcome was the change from baseline in HbA1c after 24 weeks of treatment, evaluated with an analysis of covariance (ANCOVA). Results: Mean baseline HbA1c and fasting plasma glucose (FPG) were 8.1% and 9.4 mmol/l, respectively. Linagliptin showed significant reductions vs. placebo in adjusted mean changes from baseline of HbA1c (−0.49 vs. 0.15%), FPG (−0.59 vs. 0.58 mmol/l) and 2hPPG (−2.7 vs. 1.0 mmol/l); all p < 0.0001. Hypoglycaemia was rare, occurring in three patients (0.6%) treated with linagliptin and five patients (2.8%) in the placebo group. Body weight did not change significantly from baseline in both groups (−0.5 kg placebo, −0.4 kg linagliptin). Conclusions: The addition of linagliptin 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin resulted in a significant and clinically meaningful improvement in glycaemic control without weight gain or increased risk of hypoglycaemia.
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Cites
International Diabetes Federation 2017
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Cited by
Japanese clinical practice guideline for diabetes 2019
Araki, E., Goto, A., Kondo, T., Noda, M., Noto, H., Origasa, H., Osawa, H., Taguchi, A., Tanizawa, Y., Tobe, K., et al. (2020) · Diabetology International · doi:10.1007/s13340-020-00439-5 · Cited by 545
Management of type 2 diabetes: new and future developments in treatment
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Japanese Clinical Practice Guideline for Diabetes 2019
Araki, E., Goto, A., Kondo, T., Noda, M., Noto, H., Origasa, H., Osawa, H., Taguchi, A., Tanizawa, Y., Tobe, K., et al. (2020) · Journal of Diabetes Investigation · doi:10.1111/jdi.13306 · Cited by 341
Japanese Clinical Practice Guideline for Diabetes 2016
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Groop, P.-H., Cooper, M. E., Perkovic, V., Emser, A., Woerle, H.-J., & von Eynatten, M. (2013) · Diabetes Care · doi:10.2337/dc13-0323 · Cited by 294
Self-citation
Metadata
- Authors
- Taskinen, M. ‐., Rosenstock, J., Tamminen, I., Kubiak, R., Patel, S., Dugi, K. A., & Woerle, H. ‐.
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2010-11-28
- Volume
- 13
- Issue
- 1
- Pages
- 65-74
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W2074142099
- Cited by
- 294
- References
- 35
- FWCI
- 29.06
- Type
- journal article
- Language
- en
- Open access
- closed
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- Taskinen, M. ‐., Rosenstock, J., Tamminen, I., Kubiak, R., Patel, S., Dugi, K. A., & Woerle, H. ‐. (2011). Safety and efficacy of linagliptin as add‐on therapy to metformin in patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled study. Diabetes, Obesity and Metabolism. https://doi.org/10.1111/j.1463-1326.2010.01326.x
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