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Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type?2 diabetes.

ABSTRACT: Aims/Introduction:? We assessed the long-term (52?weeks) safety and efficacy of exenatide b.i.d. in Japanese patients with type?2 diabetes and suboptimal glycemic control.? Participants completing a 24-week randomized controlled trial of exenatide (5??g, 10??g or placebo b.i.d.) were invited to continue in a 28-week open-label extension study (5??g, n?=?64; 10??g, n?=?53). Safety measures included treatment-emergent adverse events (TEAE). Efficacy measures included change from baseline in glycosylated hemoglobin A1c (HbA1c) levels, proportion of participants achieving HbA1c target levels, fasting and seven-point, self-monitored blood glucose concentrations (SMBG), 1,5-anhydroglucitol concentrations, and bodyweight.? A total of 60 and 49 participants in the exenatide 5 and 10??g groups completed the study. The 52-week incidence of TEAE considered by investigators as related to the study drug was 80.6% (58/72) and 88.9% (64/72) in the exenatide 5 and 10??g groups, respectively. Mild hypoglycemia and nausea were the most common TEAE. Most TEAE occurred during the first 24?weeks. Eight participants experienced serious adverse events. Exenatide treatment was associated with sustained decreases in HbA1c values, with 33.3-47.9% of participants achieving <6.9% HbA1c, sustained decreases in fasting plasma glucose concentrations and SMBG, and sustained increases in 1,5-anhydroglucitol concentrations. Exenatide 10??g was associated with sustained weight loss.? Long-term exenatide treatment had a similar safety profile to that observed previously and was efficacious in improving glycemic control in Japanese patients with suboptimally controlled type?2 diabetes. This trial was registered with ClinicalTrials.gov (no. NCT00577824). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00137.x, 2011).

SUBMITTER: Inagaki N

PROVIDER: S-EPMC4014904 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes.

Inagaki Nobuya N Ueki Kohjiro K Yamamura Ayuko A Saito Hitoshi H Imaoka Takeshi T

Journal of diabetes investigation 20111101 6

<h4>Unlabelled</h4>Aims/Introduction: We assessed the long-term (52 weeks) safety and efficacy of exenatide b.i.d. in Japanese patients with type 2 diabetes and suboptimal glycemic control.<h4>Materials and methods</h4> Participants completing a 24-week randomized controlled trial of exenatide (5 μg, 10 μg or placebo b.i.d.) were invited to continue in a 28-week open-label extension study (5 μg, n = 64; 10 μg, n = 53). Safety measures included treatment-emergent adverse events (TEAE). Efficacy ...[more]

PMID: 24843529

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Project description:IntroductionChanges to Treatment and Outcomes in Patients with Type 2 Diabetes Initiating Injectable Therapy (CHOICE) is a European prospective, observational cohort study assessing time to, and factors associated with, a significant change in therapy after type 2 diabetes patients initiate their first injectable glucose-lowering therapy, and these patients' clinical outcomes over 24 months. The authors report baseline data and factors associated with the injectable treatment regimen.MethodsDemographic, clinical, and healthcare resource-use data were collected at initiation of injectable therapy and analyzed using univariate tests between cohorts and multivariate logistic regression analysis for treatment.ResultsOverall, 1,177 patients initiated exenatide twice daily (b.i.d.) and 1,315 initiated insulin. Most patients were recruited by secondary-care physicians. Univariate analyses revealed statistically significant differences between the characteristics of patients who initiated exenatide b.i.d. and patients who initiated insulin. On multivariate analysis, higher body mass index [BMI; 5 kg/m(2) higher: odds ratio (OR) 2.10, 95% confidence intervals (CI) 1.84-2.40], lower glycated hemoglobin (HbA(1c); 1% higher: OR 0.77, 95% CI 0.69-0.86), and lower age (5 years older: OR 0.82, 95% CI 0.76-0.88) were the variables most strongly associated with increased probability of receiving exenatide b.i.d. (P < 0.0001). Patients initiating exenatide b.i.d. had a mean BMI of 35.3 ± 6.5 kg/m(2), HbA(1c) of 8.4 ± 1.4%, and age of 58 ± 10 years, compared with 29.7 ± 5.4 kg/m(2), 9.2 ± 1.9%, and 64 ± 11 years, respectively, in patients initiating insulin (P < 0.0001). Other characteristics significantly associated with exenatide b.i.d. initiation were "disinhibited eating" (Diabetes Health Profile-18), lower random blood glucose, less blood glucose self-monitoring, lower low-density lipoprotein cholesterol, and receipt of diet/exercise advice.ConclusionsPatients who initiated exenatide b.i.d. were on average younger and more obese with lower HbA(1c) than those initiating insulin.

Dataset Information

Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type?2 diabetes.

Publications

Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes.

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