Comparative efficacy and safety of gemigliptin versus linagliptin in type 2 diabetes patients with renal impairment: A 40-week extension of the GUARD randomized study.

Abstract

AIMS:

The long-term safety and efficacy of gemigliptin was evaluated in the present extension study after a 12-week study during a 40-week follow-up period.

METHODS:

The main study was a randomized, placebo-controlled, double-blinded, phase IIIb study in which 50 mg of gemigliptin (N = 66) or placebo (N = 66) was administered to patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal impairment over a 12-week period. Patients with a glycated haemoglobin (HbA1c) level of 7% to 11% and an estimated glomerular filtration rate (eGFR) of 15 to 59 mL/min/1.73 m2 were enrolled in the main study. After 12 weeks, patients in the gemigliptin group continued to receive gemigliptin (N = 50), whereas patients in the placebo group were transitioned from placebo to linagliptin (N = 52). Each group received the indicated treatment over the subsequent 40-week period. A total of 102 patients consented to participate in the extension study, and 79 patients ultimately completed the study.

RESULTS:

The HbA1c levels of both groups were significantly reduced at week 52 compared with baseline. Specifically, the adjusted mean change ± standard error in HbA1c level in the gemigliptin and placebo/linagliptin groups was 1.00% ± 0.21% and 0.65% ± 0.22% lower at week 52 than at baseline (P < .001 and P = .003), respectively. No significant difference in the change in HbA1c level was found between the 2 groups (P = .148). Trends in fasting plasma glucose, fructosamine and glycated albumin levels in the 2 groups were similar to trends in HbA1c levels. The eGFR of both groups was also significantly lower at week 52 than at baseline, and no significant difference in change in eGFR was found between the 2 groups. In contrast, both drugs had little effect on urinary albumin excretion, although both drugs significantly reduced the urinary type IV collagen level. The overall rates of adverse events were similar between the 2 groups.

CONCLUSIONS:

Gemigliptin and linagliptin did not differ with respect to safety and efficacy in patients with T2DM and renal impairment. The 2 drugs had similar glucose-lowering effects, and the changes in eGFR and albuminuria were also similar. Additionally, the risk of side effects, including hypoglycaemia, was similar between the 2 groups.

• Authors: Sang Youb Han, Sun Ae Yoon, Byoung Geun Han, Sung Gyun Kim, Young-Il Jo, Kyung Hwan Jeong, Kook-Hwan Oh, Hyeong Cheon Park, Sun-Hee Park, Shin-Wook Kang, Ki-Ryang Na, Sun Woo Kang, Nam-Ho Kim, Younghwan Jang, Bogyeong Kim, Seonghye Shin, Dae Ryong Cha
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 20 Issue 2 Pg. 292-300 (02 2018) ISSN: 1463-1326 [Electronic] England
• PMID: 28719008 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2017 John Wiley & Sons Ltd.

Chemical References

• Dipeptidyl-Peptidase IV Inhibitors
• Hypoglycemic Agents
• Insulin
• LC15-0444
• Piperidones
• Pyrimidines
• Sulfonylurea Compounds
• Linagliptin

Topics

• Aged
• Diabetes Mellitus, Type 2 (blood, complications, drug therapy)
• Diabetic Nephropathies (complications, physiopathology)
• Dipeptidyl-Peptidase IV Inhibitors (adverse effects, therapeutic use)
• Double-Blind Method
• Drug Monitoring
• Drug Therapy, Combination (adverse effects)
• Female
• Follow-Up Studies
• Humans
• Hyperglycemia (prevention & control)
• Hypoglycemic Agents (therapeutic use)
• Insulin (therapeutic use)
• Kidney (drug effects, physiopathology)
• Linagliptin (adverse effects, therapeutic use)
• Male
• Middle Aged
• Patient Dropouts
• Piperidones (adverse effects, therapeutic use)
• Pyrimidines (adverse effects, therapeutic use)
• Renal Insufficiency, Chronic (complications, physiopathology)
• Severity of Illness Index
• Sulfonylurea Compounds (therapeutic use)