Efficacy and Safety of Linagliptin in Black/African American Patients with Type 2 Diabetes: A 6-Month,Randomized, Double-Blind,Placebo-Controlled Study |
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| Affiliation: | 1. Medical Investigations Inc, Little Rock, Arkansas;2. Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut;3. Boehringer Ingelheim Ltd, Bracknell, United Kingdom;4. Boehringer Ingelheim GmbH and Co, KG, Ingelheim, Germany.;1. Pharmacogenetics Unit; UGC Provincial de Farmacia de Granada; Instituto de Investigación Biosanitaria de Granada; Complejo Hospitalario de Granada, Granada, Spain;2. Environmental Protection Department; Estación Experimental del Zaidín (EEZ); Spanish National Research Council (CSIC); Granada, Spain;;3. Instituto de Biología Molecular y Celular, Universidad Miguel Hernández, Elche, Alicante, Spain;4. UGC Anatomía Patológica, Complejo Hospitalario de Granada, Granada, Spain;5. Servicio de Endocrinología, Complejo Hospitalario de Granada, Granada, Spain;6. Servicio de Medicina Nuclear, Complejo Hospitalario de Granada, Granada, Spain.;1. Endocrine Section, Department of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.;2. Puerto Rico Clinical and Translational Research Consortium, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.;1. Diskapi Yildirim Beyazit Training and Research Hospital, Department of Endocrinology and Metabolic Diseases, Ankara, Turkey;2. Ankara University, School of Medicine, Department of Endocrinology and Metabolic Diseases, Ankara, Turkey;3. Diskapi Yildirim Beyazit Training and Research Hospital, Department of Biochemistry, Ankara, Turkey;4. Hacettepe University, School of Medicine (Kastamonu), Ankara-Turkey.;1. Department of Otolaryngology-Head & Neck Surgery, McGill Thyroid Cancer Center, Montreal, Canada;2. Department of Medicine, Division of Endocrinology and Metabolism, Jewish General Hospital, Montreal, Canadas;3. Department of Medicine, Division of Clinical Epidemiology, Research Institute of the McGill University Health Centre, Montreal, Canada;4. Department of Pathology, McGill Thyroid Cancer Center, Montreal, Canada. |
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| Abstract: | ObjectiveAlthough black/African American individuals are disproportionately affected by type 2 diabetes, there is scant clinical trial information available on antidiabetes therapies in this group. We compared linagliptin with placebo in black/African American adults who were treatment-naïve or receiving one oral antidiabetes drug.MethodsOf 226 patients randomized to 24 weeks’ linagliptin 5 mg/day or placebo, 208 had baseline and at least one on-treatment glycated hemoglobin (HbA1c) measurement. Mean baseline HbA1c was 8.6% in the linagliptin group (n = 98) and 8.68% in the placebo group (n = 110). The primary outcome was change in HbA1c from baseline to week 24.ResultsBy week 24, mean HbA1c changes were − 0.84% with linagliptin and − 0.25% with placebo (treatment difference, − 0.58%; P < .001), and more patients in the linagliptin group achieved HbA1c < 7.0% (26.8% vs. 8.3%; P = .001) or an HbA1c reduction ≥ 0.5% (54.1% vs. 30.0%; P < .001). Mean weight loss was − 1.1 kg in both groups. During the treatment period, 8 of 98 linagliptingroup patients and 17 of 110 placebo-group patients required rescue therapy (odds ratio, 0.5; P = .14). For postprandial glucose, values were available for few patients (11 placebo, 10 linagliptin), and thus the between-group difference was associated with wide confidence intervals (CIs) (difference, − 1.97 mg/dL; 95% CI, − 53.80 to 49.86; P = .94). In the overall study population, a similar proportion of patients in both groups had adverse events (58.5% vs. 61.7%); most events were mild or moderate and considered unrelated to study drug. Investigator-defined hypoglycemia was rare (3 linagliptin-group patients and 1 placebogroup patient), with no severe events (requiring external assistance).ConclusionThis study confirms that linagliptin is efficacious and well tolerated in black/African American patients with type 2 diabetes. (Endocr Pract. 2014;20: 412-420) |
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