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Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies.

ABSTRACT: Standardized patient-reported outcome (PRO) questionnaires can be utilized to evaluate treatment satisfaction (subjective evaluation of treatment) in patients with type 2 diabetes (T2D). These outcomes are important because they may affect patient adherence and overall study results.PROs were evaluated in two randomized 26-week clinical trials in Japanese patients with T2D taking dulaglutide 0.75 mg (dulaglutide) once weekly; comparators were once-daily liraglutide (0.9 mg/day) and once-weekly placebo in one study and once-daily insulin glargine (glargine) in the other study. The Perceptions About Medications-Diabetes 21 Questionnaire - Japanese version (PAM-D21-J) and the Injectable Diabetes Medication Questionnaire - Japanese version (IDMQ-J) were completed by patients in both studies. These measures were both considered exploratory endpoints. All scale scores range from 0 to 100, with higher scores reflecting better outcomes.Patients reported that dulaglutide was more convenient and flexible than liraglutide (PAM-D21-J Convenience/Flexibility subscale: dulaglutide least-square mean [LSM], 84.58; liraglutide LSM, 78.94; p = .026), and that they were more satisfied with dulaglutide than with liraglutide (IDMQ-J Satisfaction subscale: dulaglutide, 75.24; liraglutide, 69.53; p = .012). Patients also reported that dulaglutide was more convenient and flexible than glargine (PAM-D21-J Convenience/Flexibility subscale: dulaglutide, 87.89; glargine, 79.22; p < .001), and that they were more satisfied with dulaglutide than with glargine (IDMQ-J Satisfaction subscale: dulaglutide, 78.86; glargine, 69.66; p < .001), and felt dulaglutide was more effective than glargine, with fewer symptoms and adverse events (PAM-D21-J Perceived Effectiveness subscale: dulaglutide, 77.61; glargine, 67.22; p < .001; Emotional Effects subscale: dulaglutide, 93.02; glargine, 89.55; p = .017; IDMQ-J Blood Glucose Control subscale: dulaglutide, 76.33; glargine, 67.57; p < .001). In addition, patients responded that dulaglutide was superior to placebo in the PAM-D21-J Convenience/Flexibility, Perceived Effectiveness, and Emotional Effects subscales and all IDMQ-J subscales (Satisfaction, Ease of Use, Lifestyle Impact, Blood Glucose Control).Overall, after 26 weeks of once-weekly dulaglutide administration in Japanese patients with T2D, PROs were generally positive versus the three comparator treatments (liraglutide, glargine, and placebo), suggesting increased treatment satisfaction through better blood glucose control and convenience/flexibility and reduced negative emotional effects of diabetes.ClinicalTrials.gov (monotherapy study: NCT01558271 , registered March 12, 2012; combination therapy study: NCT01584232 , registered April 23, 2012).

SUBMITTER: Suzuki S

PROVIDER: S-EPMC5468988 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies.

Suzuki Shuichi S Oura Tomonori T Takeuchi Masakazu M Boye Kristina S KS

Health and quality of life outcomes 20170612 1

<h4>Background</h4>Standardized patient-reported outcome (PRO) questionnaires can be utilized to evaluate treatment satisfaction (subjective evaluation of treatment) in patients with type 2 diabetes (T2D). These outcomes are important because they may affect patient adherence and overall study results.<h4>Methods</h4>PROs were evaluated in two randomized 26-week clinical trials in Japanese patients with T2D taking dulaglutide 0.75 mg (dulaglutide) once weekly; comparators were once-daily liraglu ...[more]

PMID: 28606095

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Project description:IntroductionAlthough global studies have investigated the combination of dulaglutide with insulin in patients with type 2 diabetes mellitus (T2DM), differences in lean body mass and dulaglutide dosing can complicate the extrapolation of global study results to Japanese patients. This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.MethodsPatients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs). Patients were randomized in a 3:1 ratio to dulaglutide or placebo. The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).ResultsPatients (N = 159) were randomized to dulaglutide (n = 120) or placebo (n = 39). The least-squares (LS) mean changes from baseline in HbA1c at week 16 were dulaglutide - 1.45% and placebo 0.06%. The LS mean and 95% confidence interval for the difference were - 1.50% (- 1.73%, - 1.28%) and dulaglutide was superior to placebo. There were no significant differences between treatment groups in changes from baseline in body weight and insulin dose. The most frequently observed treatment-emergent adverse events in dulaglutide were nasopharyngitis, constipation, abdominal discomfort, nausea, and decreased appetite. The incidence rates of hypoglycemic events by week 16 were dulaglutide 42.5% and placebo 30.8% (P = 0.258).ConclusionOnce-weekly dulaglutide 0.75 mg was superior to once-weekly placebo in glycemic control improvement and well tolerated in patients with T2DM in combination with insulin therapy with or without OADs.Trial registrationClinicalTrials.gov, NCT02750410.FundingEli Lilly and Company.

Project description:IntroductionOnce-weekly semaglutide 1 mg is a novel glucagon-like peptide 1 receptor agonist (GLP-1 RA) that, in the SUSTAIN clinical trials, has demonstrated greater reductions in glycated haemoglobin (HbA1c) and body weight than the other GLP-1 RAs exenatide extended-release (ER) 2 mg, dulaglutide 1.5 mg and liraglutide 1.2 mg. The aim of this analysis was to evaluate the relative cost of control of achieving treatment goals in people with type 2 diabetes (T2D) treated with once-weekly semaglutide versus exenatide ER, dulaglutide and liraglutide from a UK perspective.MethodsProportions of patients reaching HbA1c targets (< 7.0% and < 7.5%), weight loss targets (≥ 5% reduction in body weight) and composite endpoints (HbA1c < 7.0% without weight gain or hypoglycaemia; reduction in HbA1c of ≥ 1% and weight loss of ≥ 5%) were obtained from the SUSTAIN clinical trials. Annual per patient treatment costs were based on wholesale acquisition costs from July 2019 in the UK. Cost of control was calculated by plotting relative treatment costs against relative efficacy.ResultsThe annual per patient cost was similar for all GLP-1 RAs. Once-weekly semaglutide was superior to exenatide ER, dulaglutide and liraglutide in bringing patients to HbA1c and weight loss targets, and to composite endpoints. When looking at the composite endpoint of HbA1c < 7.0% without weight gain or hypoglycaemia, exenatide ER, dulaglutide and liraglutide were 50.0%, 21.6% and 51.3% less efficacious in achieving this, respectively, than once-weekly semaglutide. Consequently, the efficacy-to-cost ratios for once-weekly semaglutide were superior to all comparators in bringing patients to all endpoints.ConclusionsThe present study showed that once-weekly semaglutide offers superior cost of control versus exenatide ER, dulaglutide and liraglutide in terms of achieving clinically relevant, single and composite endpoints. Once-weekly semaglutide 1 mg would therefore represent good value for money in the UK setting.

Project description:PURPOSE:In East Asian patients, type 2 diabetes mellitus (T2DM) is characterized primarily by β-cell dysfunction, with lower insulin secretion than in Caucasian individuals. Therefore, bolus insulin and premixed insulin containing a bolus insulin component are important therapeutic tools in Japan, in addition to basal insulin. This subgroup analysis is stratified by insulin regimen and uses data from a phase 4, randomized, placebo-controlled, double-blind and subsequent open-label study in Japan to assess the efficacy and safety of once-weekly dulaglutide combined with various insulin therapies. METHODS:This multicenter study enrolled Japanese patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (HbA1c) ≥ 7.5% to ≤ 10.5%] on insulin therapy [basal (B), premixed (PM), or basal bolus (BB)] in combination with or without one or two oral antidiabetic agents. Randomized participants received once-weekly dulaglutide 0.75 mg (n = 120) or placebo (n = 39) during a 16-week double-blind treatment period, and dulaglutide during a 36-week open-label extension. In this subgroup analysis, efficacy measures were changes from baseline in HbA1c, 7-point self-monitored blood glucose profiles, and body weight. Safety measures were incidence of adverse events and hypoglycemia during the first 16 weeks. RESULTS:At week 16, least squares mean differences (95% CI) regarding changes from baseline in HbA1c for each insulin regimen versus placebo were: B: - 1.62% (- 1.96, - 1.28), PM: - 1.78% (- 2.25, - 1.30), and BB: - 1.15% (- 1.54, - 0.77); p < 0.001 dulaglutide vs. placebo for each subgroup. No significant differences in body weight changes were observed between dulaglutide and placebo for any insulin regimen. Gastrointestinal symptoms were the most commonly observed adverse events in dulaglutide-treated patients. Hypoglycemia incidence rates were: B: dulaglutide 38.5% vs. placebo 23.5%; PM: dulaglutide 38.5% vs. placebo 44.4%; BB: dulaglutide 50.0% vs. placebo 30.8%. CONCLUSIONS:Overall, dulaglutide was generally well tolerated and improved glycemic control significantly versus placebo, regardless of insulin regimen. TRIAL REGISTRATION:ClinicalTrials.gov identifier, NCT02750410.

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Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies.

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Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies.

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