Affiliation:
1. National Research Institute, Los Angeles, CA
2. University of Texas Health Science Center, San Antonio, TX
3. Boehringer Ingelheim Ltd., Bracknell, Berkshire, U.K.
4. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
5. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
Abstract
OBJECTIVE
To evaluate the efficacy and safety of empagliflozin/linagliptin in subjects with type 2 diabetes.
RESEARCH DESIGN AND METHODS
Subjects not receiving antidiabetes therapy for ≥12 weeks were randomized to empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 135), empagliflozin 10 mg (n = 134), or linagliptin 5 mg (n = 135) for 52 weeks. The primary end point was change from baseline in HbA1c at week 24.
RESULTS
Mean HbA1c at baseline was 7.99–8.05% (64 mmol/mol). At week 24, adjusted mean (SE) changes from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg were −1.08 (0.06)% (−11.8 [0.7] mmol/mol), −1.24 (0.06)% (−13.6 [0.7] mmol/mol), −0.95 (0.06)% (−10.4 [0.7] mmol/mol), −0.83 (0.06)% (−9.1 [0.7] mmol/mol), and −0.67 (0.06)% (−7.3 [0.7] mmol/mol), respectively. Reductions in HbA1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg (P < 0.001) but not compared with empagliflozin 25 mg and were significantly greater for empagliflozin 10 mg/linagliptin 5 mg compared with the individual components (P < 0.001 for both). At week 24, 55.4%, 62.3%, 41.5%, 38.8%, and 32.3% of subjects with baseline HbA1c ≥7% (≥53 mmol/mol) reached HbA1c <7% with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg, respectively. Efficacy was maintained at week 52. The proportion of subjects with adverse events (AEs) over 52 weeks was similar across groups (68.9–81.5%), with no confirmed hypoglycemic AEs.
CONCLUSIONS
Reductions from baseline in HbA1c with empagliflozin/linagliptin were significantly different versus linagliptin and empagliflozin 10 mg but not versus empagliflozin 25 mg. Empagliflozin/linagliptin was well tolerated.
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
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