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Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open-label, multicenter study.

ABSTRACT: To assess the overall safety and efficacy of lixisenatide in combination with background oral antidiabetic drug treatment in Japanese patients with type 2 diabetes, as required by Japanese guidelines.A phase 3, multicenter, uncontrolled, open-label, four-arm, parallel-group study of Japanese outpatients with type 2 diabetes was carried out; patients received once-daily lixisenatide in combination with biguanide, thiazolidinedione, alpha-glucosidase inhibitors or glinide (NCT01940965). The primary end-point was safety over 52 weeks; secondary end-points included absolute change from baseline in glycated hemoglobin A1c at weeks 24 and 52.A total of 294 patients were enrolled (biguanide, thiazolidinedione, alpha-glucosidase groups: 73 patients each; glinide group: 75 patients). Overall, 90.4% of patients in the biguanide group, 83.6% in the thiazolidinedione group, 83.6% in the alpha-glucosidase group and 85.3% in the glinide group reported one or more treatment-emergent adverse event, the most common of which were nasopharingitis, nausea and constipation. Symptomatic hypoglycemia was reported in 5.5, 0, 1.4, and 10.7% of patients in the biguanide, thiazolidinedione, alpha-glucosidase and glinide groups, respectively. No severe hypoglycemia was observed. Hemoglobin A1c decreased from baseline at weeks 24 and 52, with mean changes ranging from -0.98 to -1.22%, and from -0.80 to -1.08%, respectively, across all groups.Lixisenatide treatment administered daily over 52 weeks was well tolerated and effective in improving glycemic control in Japanese patients with type 2 diabetes uncontrolled with existing oral antidiabetic drug therapies. The use of lixisenatide in combination with oral antidiabetic drugs is a valuable treatment option for Japanese patients with type 2 diabetes after failure of oral antidiabetic treatment alone.

SUBMITTER: Seino Y

PROVIDER: S-EPMC5754542 | biostudies-other | 2018 Jan

REPOSITORIES: biostudies-other

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Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open-label, multicenter study.

Seino Yutaka Y Stjepanovic Aleksandra A Takami Akane A Takagi Hiroki H

Journal of diabetes investigation 20170612 1

<h4>Aim/introduction</h4>To assess the overall safety and efficacy of lixisenatide in combination with background oral antidiabetic drug treatment in Japanese patients with type 2 diabetes, as required by Japanese guidelines.<h4>Materials and methods</h4>A phase 3, multicenter, uncontrolled, open-label, four-arm, parallel-group study of Japanese outpatients with type 2 diabetes was carried out; patients received once-daily lixisenatide in combination with biguanide, thiazolidinedione, alpha-gluc ...[more]

PMID: 28429860

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Project description:IntroductionEarly discontinuation and poor adherence are common limitations of conventional preventive migraine medications that limit their long-term efficacy. Therefore, a migraine preventive medication with favorable long-term safety is warranted.ObjectiveThis study aimed to evaluate the long-term safety and tolerability of fremanezumab for the preventive treatment of chronic or episodic migraine in Japanese patients.MethodsIn this 52-week, randomized, open-label, parallel-group study, fremanezumab monthly or quarterly was administered in newly enrolled Japanese patients with chronic migraine or episodic migraine. Safety was assessed by monitoring of treatment-emergent adverse events, including injection-site reactions, laboratory and vital sign assessments. Newly enrolled patients and rollover patients from previous phase IIb/III trials who did not receive fremanezumab in this study were included in the immunogenicity testing cohort (n = 587). Efficacy outcomes included changes from baseline in the average monthly migraine days and headache days of at least moderate severity. Other efficacy outcomes included changes in disability scores.ResultsA total of 50 patients were enrolled with chronic migraine (monthly, n = 17; quarterly, n = 17) or episodic migraine (monthly, n = 8; quarterly, n = 8). The most commonly reported treatment-emergent adverse events were nasopharyngitis (64.0%) and injection-site reactions (erythema, 24.0%; induration, 10.0%; pain, 8.0%; pruritus, 6.0%). The discontinuation rate was low (4.0% from adverse events, 2.0% from a lack of efficacy) and no deaths were reported. The incidence of anti-drug antibody development was low (2.4%). Fremanezumab reduced monthly migraine days and headache days of at least moderate severity from 1 month after initial administration, and this effect was maintained with no worsening throughout 12 months. Fremanezumab also led to sustained reductions in any acute headache medication use and headache-related disability at 12 months.ConclusionsFremanezumab administered monthly and quarterly was well tolerated in patients with chronic migraine and episodic migraine and led to sustained improvements in monthly migraine days and headache days of at least moderate severity throughout 12 months.Clinical trial registrationClinicalTrials.gov Identifier: NCT03303105.

Project description:IntroductionWe comprehensively evaluated the effects of combination therapy with insulin glargine and the incretin-based drugs lixisenatide or vildagliptin in Japanese patients with type 2 diabetes.MethodsIn this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with insulin glargine and sitagliptin. The dose of insulin glargine was titrated after the switch to maintain fasting blood glucose at approximately 110 mg/dL. The primary end points of the study were the change in glycosylated hemoglobin (HbA1c) level between before and 12 weeks after the treatment switch, the proportion of patients achieving an HbA1c level below 7.0%, and the postprandial increase in glucose concentration as assessed by self-monitoring of blood glucose.ResultsThe change in HbA1c level from baseline to 12 weeks did not differ significantly between the lixisenatide and vildagliptin groups (- 0.6 ± 0.7% and - 0.6 ± 1.2%, respectively, P = 0.920). Neither the proportion of patients achieving an HbA1c level below 7.0% nor the postprandial increase in glucose concentration was different between two groups. Body weight and serum low density lipoprotein (LDL) cholesterol level decreased significantly in the lixisenatide and vildagliptin groups, respectively. Both drugs were associated with mild gastrointestinal symptoms but not with severe hypoglycemia. Vildagliptin was associated with elevation of serum aspartate transaminase. Treatment satisfaction as assessed with the Diabetes Treatment Satisfaction Questionnaire did not differ significantly between the two groups.ConclusionThe combinations of basal insulin and either lixisenatide or vildagliptin have similar efficacies with regard to improvement of glycemic control.Trial registrationThis trial has been registered with UMIN (No. 000010769).

Dataset Information

Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open-label, multicenter study.

Publications

Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open-label, multicenter study.

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