Trial reportAdvances in therapy2018
Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials.
Trial report in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01422876 (A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components), which is not on this map. Cited by 7 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Who cites it
7 citing papers in PubMed.
- Efficacy and Safety of Fixed-Dose Combinations of Sitagliptin and Empagliflozin as Add-On to Metformin in Korean Patients With Type 2 Diabetes: A Randomised, Double-Blind, Multi-Centre, Placebo-Controlled, Phase III Trial.Diabetes, obesity & metabolism · 2026Trial
- Comparative Safety of SGLT2 Versus DPP4 Inhibitors in Patients with Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Pharmacological and Non-Pharmacological Interventions in Diabetes Mellitus: Effects on Epicardial Adipose Tissue.International journal of molecular sciences · 2025Review
- Exploring the Real-World Effectiveness of Empagliflozin and Linagliptin Fixed-Dose Combination in Type 2 Diabetes Patients of Bangladesh: A Prospective Multi-Center Observational Study.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025Article
- Comparison of glimepiride and linagliptin in the treatment of non-alcoholic hepatic disease with type 2 diabetes mellitus.Archives of medical science : AMS · 2024Article
- Expert Opinion: Optimum Clinical Approach to Combination-Use of SGLT2i + DPP4i in the Indian Diabetes Setting.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022Article
- Incipient Diabetes Treated with Long-Term Classical Prescription.Journal of diabetes research · 2019Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTwo 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.
methodsA total of 1363 patients were treated with empagliflozin 25 mg/linagliptin 5 mg (n = 273), empagliflozin 10 mg/linagliptin 5 mg (n = 272), empagliflozin 25 mg (n = 276), empagliflozin 10 mg (n = 275), or linagliptin 5 mg (n = 267). Adverse events (AEs) were assessed descriptively in patients who took ≥ 1 dose of study drug.
resultsTotal 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.
conclusionEmpagliflozin/linagliptin as monotherapy or add-on to metformin for 52 weeks was well tolerated in patients with T2DM, with safety profiles similar to individual components, including a low risk of hypoglycemia.
fundingThe Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance.
trial registrationClinicalTrials.gov identifiers, NCT01422876 & NCT01422876.
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