Dataset Information

Effect of once weekly dulaglutide by baseline beta-cell function in people with type 2 diabetes in the AWARD programme.

ABSTRACT: Glucagon-like peptide-1 receptor agonists lower blood glucose in type 2 diabetes (T2D) partially through glucose-dependent stimulation of insulin secretion. The aim of this study was to investigate whether beta-cell function (as measured by HOMA2-%B) at baseline affects the glycaemic response to dulaglutide. Dulaglutide-treated patients from AWARD-1, AWARD-3 and AWARD-6 clinical studies were categorised based on their homeostatic model assessment of beta-cell function (HOMA2-%B) tertiles. Changes in glycaemic measures in response to treatment with once-weekly dulaglutide were evaluated in each HOMA2-%B tertile. Patients with low HOMA2-%B had higher baseline glycated haemoglobin (HbA1c), fasting and postprandial blood glucose, and longer duration of diabetes (P?

SUBMITTER: Mathieu C

PROVIDER: S-EPMC6055818 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other

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Effect of once weekly dulaglutide by baseline beta-cell function in people with type 2 diabetes in the AWARD programme.

Mathieu Chantal C Del Prato Stefano S Botros Fady T FT Thieu Vivian T VT Pavo Imre I Jia Nan N Haupt Axel A Karanikas Chrisanthi A CA García-Pérez Luis-Emilio LE

Diabetes, obesity & metabolism 20180502 8

Glucagon-like peptide-1 receptor agonists lower blood glucose in type 2 diabetes (T2D) partially through glucose-dependent stimulation of insulin secretion. The aim of this study was to investigate whether beta-cell function (as measured by HOMA2-%B) at baseline affects the glycaemic response to dulaglutide. Dulaglutide-treated patients from AWARD-1, AWARD-3 and AWARD-6 clinical studies were categorised based on their homeostatic model assessment of beta-cell function (HOMA2-%B) tertiles. Change ...[more]

PMID: 29603872

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Project description:INTRODUCTION:This analysis evaluated the efficacy and safety of dulaglutide in Chinese patients with type 2 diabetes (T2D) aged ??60 and <?60 years. METHODS:This post hoc analysis included patients with T2D enrolled in two phase 3 clinical trials AWARD-CHN1 (NCT01644500) and AWARD-CHN2 (NCT01648582) of dulaglutide 0.75 and 1.5 mg. Patients were categorized into two groups (??60 and <?60 years). Efficacy outcomes (change in glycated hemoglobin [HbA1c], fasting blood glucose [FBG], and weight; percentage of patients achieving HbA1c target [<?7.0%]) and safety outcomes (incidence of hypoglycemia and gastrointestinal treatment-emergent adverse events [GI TEAEs]) at 26 weeks were evaluated for each age group in both trials. RESULTS:A total of 766 patients (??60 years, n?=?222;?<?60 years, n?=?544) were included in the study. A similar reduction of HbA1c was observed in both age groups: AWARD-CHN1, 1.5 mg (least squares mean [LSM] 95% confidence interval [CI] ??60 years: -?1.45% [-?1.69, -?1.21%] and <?60 years: -?1.43% [-?1.59, -?1.28%]) and 0.75 mg (??60 years: -?1.29% [-?1.53, -?1.05%] and <?60 years: -?1.18% [-?1.33, -?1.03%]); AWARD-CHN2, 1.5 mg (??60 years: -?1.60% [-?1.83, -?1.36%] and <?60 years: -?1.64% [-?1.80, -?1.49%]) and 0.75 mg (??60 years: -?1.31% [-?1.55, -?1.08%] and <?60 years: -?1.33% [-?1.48, -?1.17%]). Dulaglutide showed a reduction in HbA1c as early as 4 weeks after initiation of treatment, which was maintained over 26 weeks in both age groups. The percentage of patients achieving HbA1c target?<?7.0% at 26 weeks was also similar in both age groups. Incidence of hypoglycemia and GI TEAEs was low in each age group. CONCLUSION:Treatment with once-weekly dulaglutide improved glycemic control in patients with T2D aged ??60 years and <?60 years and was well tolerated in older patients, suggesting it can be considered a safe and effective treatment option for use in older patients with T2D. TRIAL REGISTRATION:AWARD-CHN1 (NCT01644500) and AWARD-CHN2 (NCT01648582).

Project description:BackgroundType 2 Diabetes Mellitus (T2DM) is a highly prevalent disease worldwide and in Colombia, representing one of the main causes of death and placing a considerable burden on healthcare systems. 13 classes of drugs are approved for the treatment of T2DM, with Glucagon-like Peptide-1 (GLP-1) receptor agonists being a first-line treatment option for patients with or at high risk of certain cardiovascular diseases and chronic kidney disease. The objective of this study is to conduct a short-term cost-effectiveness analysis of once-weekly semaglutide versus once-weekly dulaglutide in Colombian adults with T2DM, from a third-party payer perspective.MethodsNumbers needed to treat were calculated for different single and composite endpoints of the SUSTAIN 7 trial, annual costs for once weekly semaglutide 1.0 mg and dulaglutide 1.5 mg were extracted from the public SISMED database. With these inputs a cost of control model was developed, to obtain the annual cost of bringing one T2DM patient to relevant clinical outcomes by using semaglutide or dulaglutide.ResultsSemaglutide was considered cost-effective compared to dulaglutide across all pre-specified endpoints, even in the different scenarios evaluated in the sensitivity analyses, and in a particularly pronounced manner for weight loss outcomes. Semaglutide at a dose of 1.0 mg once-weekly was cost-effective compared to dulaglutide 1.5 mg across all outcomes in the short-term, making it an appropriate first-line choice in the treatment of T2DM when deciding between these two GLP-1 receptor agonists.ConclusionsThis is the first short-term cost-effectiveness study of semaglutide and dulaglutide in T2DM Colombian patients. Our modeled results suggest that once-weekly semaglutide represents a cost-effective option for treating individuals with T2DM in Colombia who are not achieving glycaemia control with metformin, and it would be expected to improve HbA1C, promote greater weight loss and reduce costs from a third-payer perspective compared with treatment with dulaglutide.

Project description:AimsTo evaluate the efficacy and safety of dulaglutide 1.5 and 0.75?mg in patients with type 2 diabetes by subgroups of gender, duration of diabetes and baseline glycated haemoglobin (HbA1c) in the dulaglutide clinical development programme (AWARD-1 to -6 and -8 clinical trials).MethodsChange in HbA1c was analysed by gender, duration of diabetes (<5, ?5?years and <10, ?10?years), and baseline HbA1c (<8.5%, ?8.5%) in pooled and individual studies. Changes from baseline in weight, hypoglycaemia and gastrointestinal adverse events were evaluated for individual trials.ResultsIn the pooled analysis of patients treated with dulaglutide 1.5?mg at 6?months, the reductions in HbA1c from baseline were similar across gender (men: least squares [LS] mean -1.26% [95% confidence interval {CI} -1.36, -1.16]; women: LS mean -1.33% [95% CI -1.43, -1.24]) and among duration of diabetes subgroups (<5?years: LS mean -1.32% [95% CI -1.43, -1.22]; ?5 and <10?years: LS mean -1.33% [95% CI -1.43, -1.22]; ?10?years: -1.24% [95% CI -1.35, -1.14]). Patients with baseline HbA1c ?8.5% had greater HbA1c reductions than patients with baseline HbA1c <8.5%, (?8.5%: LS mean -1.86% [95% CI -1.97, -1.75]; <8.5%: LS mean -1.02% [95% CI -1.12, -0.93]). Reductions in fasting blood glucose (FBG) were consistent with HbA1c changes. Similar results were observed with dulaglutide 0.75?mg. In general, body weight changes were similar among duration of diabetes and in baseline HbA1c subgroups, respectively; women had a numerically greater weight loss or less weight gain than men with both dulaglutide doses. There was no clinically meaningful difference in hypoglycaemia trends by gender or duration of diabetes. Hypoglycaemia incidence and rate were generally lower in patients with baseline HbA1c ?8.5% than in those with <8.5%, except for the AWARD-4 study (combination with mealtime insulin).ConclusionsAcross the AWARD studies, dulaglutide demonstrated significant improvements in glycaemic control irrespective of gender, duration of diabetes, or baseline HbA1c, with greater HbA1c and FBG reductions in patients with a higher baseline HbA1c. Dulaglutide was well tolerated, with a safety profile similar to other glucagon-like peptide-1 receptor agonists.

Dataset Information

Effect of once weekly dulaglutide by baseline beta-cell function in people with type 2 diabetes in the AWARD programme.

Publications

Effect of once weekly dulaglutide by baseline beta-cell function in people with type 2 diabetes in the AWARD programme.

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