Efficacy and safety of gemigliptin as add‐on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study)

The objective of this study was to evaluate the efficacy and safety of gemigliptin added to a stable dose of insulin alone or of insulin in combination with metformin in patients with type 2 diabetes mellitus. After a two‐week run‐in period, patients were randomized 2:1 to receive gemigliptin 50 mg...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2020-01, Vol.22 (1), p.123-127
Main Authors: Cho, Young Min, Deerochanawong, Chaicharn, Seekaew, Samroeng, Suraamornkul, Swangjit, Benjachareonwong, Sunun, Sattanon, Sarinya, Chamnan, Parinya, Sirirak, Thanitha, Kosachunhanun, Natapong, Pratipanawatr, Thongchai, Suwanwalaikorn, Sompongse, Lee, Woo Je, Kim, Sungrae, Choi, Seonghui, Kang, Eun Seok, Oh, Taekeun, Kwon, Sam, Lee, Moon‐Kyu
Format: Article
Language:English
Subjects:
Antidiabetics
Blood Glucose
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - drug therapy
dipeptidyl peptidase‐4
Dipeptidyl-Peptidase IV Inhibitors - adverse effects
Dipeptidyl-Peptidase IV Inhibitors - therapeutic use
Double-Blind Method
Drug Therapy, Combination
gemigliptin
Glycated Hemoglobin A - analysis
Hemoglobin
Humans
Hypoglycemia
Hypoglycemia - chemically induced
Hypoglycemic Agents - therapeutic use
Insulin
Insulin - therapeutic use
Metformin
Metformin - therapeutic use
Piperidones - adverse effects
Piperidones - therapeutic use
Pyrimidines - adverse effects
Pyrimidines - therapeutic use
Statistical analysis
Treatment Outcome
type 2 diabetes mellitus
Weight Gain
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Summary:The objective of this study was to evaluate the efficacy and safety of gemigliptin added to a stable dose of insulin alone or of insulin in combination with metformin in patients with type 2 diabetes mellitus. After a two‐week run‐in period, patients were randomized 2:1 to receive gemigliptin 50 mg or placebo once daily as add‐on to background therapy with insulin or insulin plus metformin for 24 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) from baseline at Week 24. Baseline characteristics were similar between the gemigliptin (n = 188) and placebo (n = 95) groups in terms of HbA1c (8.1%). At Week 24, the gemigliptin group showed a statistically significant reduction in mean HbA1c from baseline as compared with placebo (between‐group mean difference, −0.7% [95% CI, −0.9% to −0.4%]; P‐value 
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.13873