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Tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese, Korean patients with type 2 diabetes.

ABSTRACT: AIMS/INTRODUCTION:We assessed the tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese Korean participants with type 2 diabetes. We also evaluated the characteristics of participants who respond adequately to glucagon-like peptide-1 (GLP-1) analog therapy in terms of glycated hemoglobin (HbA1c) level reductions and weight loss. MATERIALS AND METHODS:This prospective, observational, single-arm (exenatide b.i.d. in combination with both metformin and sulphonylurea), open-label study of GLP-1 analog treatment with close monitoring of metabolic parameters and weight changes was carried out for up to 22 weeks. RESULTS:Of the 110 enrolled obese participants, 37 participants dropped out during the 22-week treatment period. A total of 73 participants completed the study (median age 55.0 years, interquartile range 44.0-65.0). The median duration of diabetes was 8.0 years (interquartile range 3.5-12.5) with a mean HbA1c value of 7.6% (interquartile range 7.00-8.55). The median body mass index was 30.78 kg/m(2) (interquartile range 27.89-33.92). After 22 weeks, median changes from baseline for HbA1c levels and weight were -0.7% and -3.0 kg, respectively, which were significant. No severe hypoglycemic events were observed. Multivariate regression analysis showed that C-peptide values were a significant independent predictor for a reduction in HbA1c levels (? = 0.865, P = 0.018) with exenatide BID in combination with both sulphonylurea and metformin in obese Korean participants with type 2 diabetes and insulin naïveté. CONCLUSIONS:Clinical and laboratory parameters, such as insulin naïveté and preserved ?-cell function, should be taken into consideration as important factors in the choice of GLP-1 analog when predicting GLP-1 analog responsiveness. This trial was registered with the local committee at Yonsei University in Korea (4-2011-0032).

SUBMITTER: Song SO

PROVIDER: S-EPMC4188114 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese, Korean patients with type 2 diabetes.

Song Sun Ok SO Kim Kwang Joon KJ Lee Byung-Wan BW Kang Eun Seok ES Cha Bong Soo BS Lee Hyun Chul HC

Journal of diabetes investigation 20131222 5

<h4>Aims/introduction</h4>We assessed the tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese Korean participants with type 2 diabetes. We also evaluated the characteristics of participants who respond adequately to glucagon-like peptide-1 (GLP-1) analog therapy in terms of glycated hemoglobin (HbA1c) level reductions and weight loss.<h4>Materials and methods</h4>This prospective, observational, single-arm (exenatide b.i.d. in combination wi ...[more]

PMID: 25411624

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Project description: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.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 ?g 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.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.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.ClinicalTirals.gov , number NCT02090673 , registered 14 February 2008.

Project description:BACKGROUND:Exenatide once weekly (QW) is a glucagon-like peptide-1 receptor agonist (GLP-1RA) for the treatment of type 2 diabetes. Safety and tolerability are key considerations in treatment selection. This analysis examines the safety and tolerability profile of exenatide QW, other approved GLP-1RAs (exenatide twice daily and liraglutide once daily), and a pooled population of commonly used non-GLP-1RA treatments. METHODS:Intent-to-treat populations from eight randomized Phase III trials with 24-week and 30-week comparator-controlled periods were analyzed. Data were pooled for exenatide QW, exenatide twice daily, and non-GLP-1RA comparator groups; comparisons between exenatide QW and liraglutide were analyzed separately to better match study groups. The incidence of treatment-emergent adverse events with 95% confidence intervals and exposure-adjusted incidence were calculated. Duration and recurrence were analyzed for gastrointestinal adverse events and adverse events of special interest. RESULTS:Incidences of serious adverse events did not differ between treatments. Discontinuations due to adverse events occurred numerically less frequently with exenatide QW than with other GLP-1RAs but numerically more frequently than with non-GLP-1RA comparators. The most frequent adverse events in the GLP-1RA groups were gastrointestinal and generally mild, with decreasing incidence over time. Gastrointestinal adverse event incidences appeared lower with exenatide QW versus other GLP-1RAs and greater than with non-GLP-1RA comparators. Injection site-related adverse events seemed highest with exenatide QW, but generally did not lead to withdrawal and abated over time. Hypoglycemia was infrequent overall, but occurred numerically more frequently in the non-GLP-1RA comparator group and increased with concomitant sulfonylurea use. Pancreatitis, thyroid cancer, renal failure, and gallbladder disease were rarely reported. CONCLUSION:The overall safety and tolerability profile of exenatide QW was similar to that of other GLP-1RAs, with improved gastrointestinal tolerability. The safety and tolerability profile of exenatide QW compared with non-GLP-1RA comparators was similar overall, with the exception of a lower incidence of hypoglycemia and anticipated differences in gastrointestinal and injection site-related adverse events.

Dataset Information

Tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese, Korean patients with type 2 diabetes.

Publications

Tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese, Korean patients with type 2 diabetes.

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