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Comparison of the effects of gemigliptin and dapagliflozin on glycaemic variability in type 2 diabetes: A randomized, open-label, active-controlled, 12-week study (STABLE II study).
- Source :
-
Diabetes, obesity & metabolism [Diabetes Obes Metab] 2020 Feb; Vol. 22 (2), pp. 173-181. Date of Electronic Publication: 2019 Oct 17. - Publication Year :
- 2020
-
Abstract
- Aims: The aim of this study was to compare the effect of gemigliptin, a dipeptidyl peptidase-4 inhibitor, and dapagliflozin, a sodium glucose co-transporter-2 inhibitor, on glycaemic variability in type 2 diabetes patients.<br />Materials and Methods: In this randomized, blinded end point, multicentre clinical trial, we enrolled 71 patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve. The participants were randomized to receive gemigliptin 50 mg (n = 35) or dapagliflozin 10 mg (n = 36) daily for 12 weeks. Glycaemic variability was estimated by mean amplitude of glycaemic excursions (MAGE), standard deviation (SD) and coefficient of variation (CV) using a 6-day continuous glucose monitoring system. The primary efficacy endpoint was change in MAGE after 12 weeks compared to baseline.<br />Results: Intergroup differences in baseline characteristics were not significant. The adjusted mean change (± standard error) in MAGE after 12 weeks in the gemigliptin and dapagliflozin groups was -27.2 ± 4.4 mg/dL and -7.9 ± 4.9 mg/dL, respectively. Between-group comparisons showed a significantly larger reduction in MAGE in the gemigliptin group (-19.2 mg/dL; 95% CI, -31.3 to -7.2; P = .002). Measures of SD and CV also showed a significantly larger reduction in the gemigliptin group. Average glycaemic control, estimated by HbA1c, fasting glucose and safety profiles, was comparable between the two groups.<br />Conclusions: Compared to dapagliflozin, gemigliptin significantly improved glycaemic variability, with similar glucose-lowering efficacy and safety profiles in patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve.<br /> (© 2019 John Wiley & Sons Ltd.)
- Subjects :
- Adult
Aged
Benzhydryl Compounds pharmacology
Blood Glucose metabolism
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 2 blood
Fasting blood
Female
Glucosides pharmacology
Glycemic Control
Humans
Male
Metformin therapeutic use
Middle Aged
Piperidones pharmacology
Pyrimidines pharmacology
Republic of Korea
Young Adult
Benzhydryl Compounds therapeutic use
Blood Glucose drug effects
Diabetes Mellitus, Type 2 drug therapy
Glucosides therapeutic use
Piperidones therapeutic use
Pyrimidines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1463-1326
- Volume :
- 22
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Diabetes, obesity & metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 31502749
- Full Text :
- https://doi.org/10.1111/dom.13882