Linagliptin as add‐on to empagliflozin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a two‐part, randomized, placebo‐controlled trial

Aims This two‐part, double‐blind, double‐dummy, randomized, placebo‐controlled trial (83 sites) evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg and linagliptin (Lina) 5 mg fixed‐dose combinations (FDCs) in Japanese patients with type 2 diabetes mellitus (T2DM) who were poorly c...

Full description

Saved in:
Bibliographic Details
Published in:Diabetes, obesity & metabolism obesity & metabolism, 2019-01, Vol.21 (1), p.136-145
Main Authors: Kaku, Kohei, Haneda, Masakazu, Tanaka, Yuko, Lee, Ganghyuck, Shiki, Kosuke, Miyamoto, Yuki, Solimando, Fernando, Lee, Jisoo, Lee, Christopher, George, Jyothis
Format: Article
Language:English
Subjects:
Adult
Aged
Benzhydryl Compounds - administration & dosage
Benzhydryl Compounds - adverse effects
Benzhydryl Compounds - therapeutic use
Blood Glucose - analysis
Diabetes
Diabetes mellitus
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - drug therapy
Drug Combinations
Drug dosages
empagliflozin
Evidence-based medicine
Female
Glucosides - administration & dosage
Glucosides - adverse effects
Glucosides - therapeutic use
glycaemic control
Humans
Hypoglycemia
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - therapeutic use
Japan
Ketoacidosis
linagliptin
Linagliptin - administration & dosage
Linagliptin - adverse effects
Linagliptin - therapeutic use
Male
Middle Aged
Original
phase III study
randomized trial
type 2 diabetes
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Aims This two‐part, double‐blind, double‐dummy, randomized, placebo‐controlled trial (83 sites) evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg and linagliptin (Lina) 5 mg fixed‐dose combinations (FDCs) in Japanese patients with type 2 diabetes mellitus (T2DM) who were poorly controlled with Empa. Materials and methods Patients (previously drug‐naive or using one oral antidiabetic drug for ≥ 12 weeks) entered an open‐label stabilization period (16 weeks, Empa 10 mg [Part A] or Empa 25 mg [Part B]). Subsequently, they received Empa 10 mg plus placebo (Plc) for Empa/Lina10/5 (Empa/Plc 10/5; Part A) or Empa 25 mg plus Plc for Empa/Lina 25/5 (Empa/Plc 25/5; Part B) for 2 weeks. Patients with HbA1c 7.5–10.0% were randomized (1:1) to a 24‐week regimen of once‐daily Empa/Lina 10/5 (n = 107) or Empa/Plc 10/5 (n = 108) in Part A, or to Empa/Lina 25/5 (n = 116) or Empa/Plc 25/5 (n = 116) in Part B, with a 28‐week extension period in Part B. Results Change from baseline in HbA1c at Week 24 was greater (P < 0.0001) with Empa/Lina than with Empa/Plc (primary outcome, Empa/Lina 10/5: −0.94 vs −0.12%; adjusted mean difference, −0.82%; Empa/Lina 25/5: −0.91 vs −0.33%; adjusted mean difference, −0.59%). Over 24‐ and 52‐week periods, higher proportions of patients achieved HbA1c < 7.0% and greater decreases in fasting plasma glucose were observed with Empa/Lina compared with Empa/Plc. Empa/Lina was well tolerated, with no unexpected adverse events or diabetic ketoacidosis. One case of confirmed hypoglycaemia with Empa/Plc 25/5 was reported. Conclusions These results support Empa/Lina FDC as a potential option for Japanese patients with T2DM who require combination therapy. ClinicalTrials.gov NCT02489968.
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.13496