Efficacy, safety and albuminuria-reducing effect of gemigliptin in Korean type 2 diabetes patients with moderate to severe renal impairment: A 12-week, double-blind randomized study (the GUARD Study)
| Autor: | Young Il Jo, Kyung Hwan Jeong, Seong Hee Shin, Shin W. Kang, Sun A. Yoon, Nam H. Kim, K.-R. Na, Hyeong C. Park, Sun W. Kang, Sun H. Park, Byoung G. Han, Dae R. Cha, Young Ho Jang, Kook Hwan Oh, Sang Y. Han, Sung G. Kim |
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| Rok vydání: | 2016 |
| Předmět: |
Blood Glucose
Male medicine.medical_specialty Endocrinology Diabetes and Metabolism Urology Renal function 030209 endocrinology & metabolism Type 2 diabetes Placebo 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Endocrinology Double-Blind Method Internal medicine Republic of Korea Internal Medicine Medicine Albuminuria Humans Hypoglycemic Agents Diabetic Nephropathies 030212 general & internal medicine Piperidones Aged Glycated Hemoglobin Creatinine business.industry Body Weight Middle Aged medicine.disease Gemigliptin Fructosamine Pyrimidines Treatment Outcome chemistry Diabetes Mellitus Type 2 Microalbuminuria Female medicine.symptom business |
| Zdroj: | Diabetes, obesitymetabolism. 19(4) |
| ISSN: | 1463-1326 |
| Popis: | Aims This multicentre, randomized, double-blind study investigated the efficacy and safety of gemigliptin in Korean type 2 diabetes mellitus (T2DM) patients with moderate to severe renal impairment (RI). Methods The study comprised a 12-week main part and a 40-week extension. We report here the results from the main part. In total, 132 patients were randomized to receive gemigliptin (n = 66) or placebo (n = 66). Changes in glycated haemoglobin (HbA1c; primary endpoint), other glycaemic control parameters (fasting plasma glucose, glycated albumin and fructosamine), lipid profiles, renal function parameters and safety profiles were evaluated. Results Baseline characteristics were comparable between the groups (mean HbA1c, 8.4% [68 mmol/mol]; age, 62.0 years; duration of type 2 diabetes, 16.3 years; estimated glomerular filtration rate, 33.3 mL/min/1.73 m2). At Week 12, the adjusted mean change ± standard error in HbA1c with gemigliptin was −0.82% ± 0.14% (−8.9 ± 1.5 mmol/mol), whereas it was 0.38% ± 0.14% (4.2 ± 1.5 mmol/mol) with placebo (significant between-group difference, P |
| Databáze: | OpenAIRE |
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