Abstract | INTRODUCTION: Two 52-week Phase III studies evaluated the efficacy and safety of once-daily combinations of empagliflozin/ linagliptin as monotherapy or add-on to metformin in patients with type 2 diabetes (T2DM). The aim of this analysis was to further assess the safety and tolerability of empagliflozin/ linagliptin compared with their individual components in patients with T2DM, using pooled data from these trials. METHODS: RESULTS: Total exposure was 251, 255, 256, 249, and 243 patient-years in the empagliflozin 25 mg/ linagliptin 5 mg, empagliflozin 10 mg/ linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg groups, respectively. The proportion of patients with ≥ 1 AE was similar across groups (70.4-74.9%). The percentage of patients with confirmed hypoglycemic AEs (plasma glucose ≤ 70 mg/dL and/or requiring assistance) was low in all groups (1.1-2.2%); none required assistance. Events consistent with urinary tract infection were reported in similar percentages of patients in all groups (11.4-13.8%), and in a greater proportion of female than male patients. Events consistent with genital infection were reported in higher percentages of patients on empagliflozin/ linagliptin or empagliflozin (4.0-6.5%) than linagliptin 5 mg (2.6%), and in a greater proportion of females than males. The risks of hypersensitivity reactions and events consistent with volume depletion were low across treatment groups. CONCLUSION: FUNDING: The Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance. TRIAL REGISTRATION: ClinicalTrials.gov identifiers, NCT01422876 & NCT01422876.
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Authors | Ralph A DeFronzo, Christopher Lee, Sven Kohler |
Journal | Advances in therapy
(Adv Ther)
Vol. 35
Issue 7
Pg. 1009-1022
(Jul 2018)
ISSN: 1865-8652 [Electronic] United States |
PMID | 29949041
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Benzhydryl Compounds
- Glucosides
- Hypoglycemic Agents
- Linagliptin
- Metformin
- empagliflozin
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Topics |
- Benzhydryl Compounds
(administration & dosage, adverse effects)
- Diabetes Mellitus, Type 2
(blood, diagnosis, drug therapy)
- Dose-Response Relationship, Drug
- Drug Monitoring
(methods)
- Female
- Glucosides
(administration & dosage, adverse effects)
- Humans
- Hypoglycemia
(chemically induced, diagnosis, prevention & control)
- Hypoglycemic Agents
(administration & dosage, adverse effects)
- Linagliptin
(administration & dosage, adverse effects)
- Male
- Metformin
(administration & dosage, adverse effects)
- Middle Aged
- Treatment Outcome
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