Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice

Abstract

Background: Randomized clinical trials have shown the efficacy and safety of short-acting exenatide in patients with type 2 diabetes mellitus (T2DM). The aim of this observational study was to investigate the effectiveness and safety of exenatide twice a day in Korean patients with T2DM who are suboptimally controlled with oral hypoglycemic agents.

Methods: This study was a post hoc analysis of multi-center (71 centers), prospective, observational, single-arm, post-marketing study of short-acting exenatide 5 to 10 μg twice a day from March 2008 to March 2014 and analyzed those who finished the follow-up over 20 weeks of medication. Changes of hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and body weight values before and after exenatide treatment were analyzed. Adverse events and adverse drug reactions were estimated in patients who were treated with exenatide at least once and for whom follow-up for safety has been completed.

Results: After 20 weeks treatment with exenatide, mean HbA1c and body weight were significantly reduced from 8.4% to 7.7% and from 83.4 kg to 80.2 kg, respectively (both p < 0.001). Subjects with higher baseline glucose and HbA1c levels showed an independent association with a greater reduction in glucose level. In addition, short duration of diabetes less than 5 years was an independent predictor for the improvement in glucose level. The majority of study subjects showed a reduction in both body weight and glucose level (63.3%) after exenatide treatment. In terms of safety profile, exenatide treatment was generally well-tolerated and the incidence of severe adverse event was rare (0.8%). The gastrointestinal side effects were most common and hypoglycemia was reported in 1.7% of subjects.

Conclusion: In real clinical practice, 20 weeks treatment with short-acting exenatide was well tolerated and showed a significant body weight and glucose reduction in Korean patients with T2D who are suboptimally controlled with oral hypoglycemic agents.

Trial registration: ClinicalTirals.gov , number NCT02090673 , registered 14 February 2008.

Keywords: Adverse event; Exenatide; GLP-1 analogue; Glucose; Type 2 diabetes mellitus.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol was written in accordance with the requirement of Korean Ministry of Food and Drug Safety (MFDS) and reviewed by institutional review board (IRB)/independent ethics committee at each hospital before the initiation of study enrolment (Additional file 1: Table S1). All of patients provided written informed consents. The study was carried out according to the principles of the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Study flow diagram demonstrating analysis population

Fig. 2

Changes of clinical findings from before to after short-acting exenatide over 20 weeks. (A) Hemoglobin A1c (HbA1c) level (n = 619), (B) Fasting plasma glucose (FPG) level (n = 54), (C) Body mass index (BMI) (n = 655), (D) Body weight (n = 674)

Fig. 3

Distribution of patients for the relation between Hemoglobin A1c (HbA1c) and body weight before and after treatment with short-acting exenatide over 20 weeks. Red line represents regression for HbA1c according to body weight change, which shows the correlation coefficient as 0.00357 closed to 0. It means that there is rare correlation between changes HbA1c and body weight