Versus Dulaglutide Research Articles

Treatment Satisfaction and Quality of Life with Tirzepatide Versus Dulaglutide Among Japanese Patients with Type2 Diabetes: Exploratory Evaluation of the SURPASS J-mono Trial.

Treatment satisfaction in diabetes management is vital to achieving long-term clinical outcomes. This analysis evaluated treatment satisfaction among patients with type2 diabetes (T2D) after 52weeks of treatment with once-weekly tirzepatide (5, 10, and 15mg) compared with dulaglutide 0.75mg. This exploratory analysis of the phase3 SURPASS J-mono trial assessed treatment satisfaction using the Japanese translation of the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change versions (DTSQc). Subgroup analyses were posthoc and conducted for the DTSQc overall treatment satisfaction score based on age (< 65 or ≥ 65years), sex (male or female), baseline body mass index (BMI; < 25 or ≥ 25kg/m2), and baseline glycated hemoglobin (≤ 8.5% or > 8.5%). Baseline DTSQs scores were similar among patients across all treatment arms. Overall, trends showed higher satisfaction among patients who received any tirzepatide dose compared with those who received dulaglutide after 52weeks of treatment. Mean overall DTSQc treatment satisfaction scores at week52 were significantly higher with tirzepatide 5, 10, and 15mg versus dulaglutide 0.75mg (11.5, 12.1, and 12.3, respectively, vs 8.9; P < 0.001). The DTSQc perceived frequency scores for unacceptable hyperglycemia were significantly lower with tirzepatide 5, 10, and 15mg versus dulaglutide 0.75 mg (- 1.7, - 1.8, and - 2.3, respectively, vs - 0.6; P < 0.001), while scores for unacceptable hypoglycemia were similar across all treatment arms, ranging from - 0.8 to - 1.1. Subgroup analyses showed increased treatment satisfaction with tirzepatide compared with dulaglutide in the < 65years (P < 0.001) and baseline BMI ≥ 25kg/m2 subgroups (P < 0.01 or < 0.001) and similar treatment satisfaction across treatment arms in the ≥ 65years and BMI < 25 kg/m2 subgroups. Patients with T2D reported higher treatment satisfaction with once-weekly tirzepatide (5, 10, and 15mg) compared with dulaglutide 0.75mg after 52weeks of treatment. ClinicalTrials.gov, NCT03861052.

EE178 CEA of Once-Weekly Subcutaneous Semaglutide Versus Dulaglutide in Patients with Type 2 Diabetes with Inadequate Glycemic Control in China

The objective of the current study was to assess the long-term cost-effectiveness of once-weekly (OW) subcutaneous (s.c.) semaglutide 0.5mg and 1.0mg versus dulaglutide 1.5mg for the treatment of type 2 diabetes, based on the head-to-head SUSTAIN 7 trial, to inform healthcare decision making in China.

EE79 A Cost of Control Analysis of Once-Weekly Subcutaneous Semaglutide Versus Dulaglutide for Bringing Patients to Treatment Targets in China

In the SUSTAIN 7 randomized controlled trial, once-weekly subcutaneous semaglutide (OW) subcutaneous (s.c.) 0.5mg was associated with greater reduction in glycated hemoglobin (HbA1c) and body weight in people with type 2 diabetes mellitus (T2DM) comparing dulaglutide 1.5mg. The present study estimated the annual cost per patient achieving HbA1c treatment targets and weight loss responses with OW s.c. semaglutide and dulaglutide in the Chinese healthcare system setting over a one-year period.

Lifetime Cost-effectiveness of Oral Semaglutide Versus Dulaglutide and Liraglutide in Patients With Type 2 Diabetes Inadequately Controlled With Oral Antidiabetics

PurposeTo estimate the incremental cost-utility ratio of oral semaglutide (14 mg once daily) vs other glucagon-like peptide 1 receptor agonist treatments among adults with type 2 diabetes that was inadequately controlled with 1 to 2 oral antidiabetic drugs from a US payer perspective. MethodsA state-transition model with a competing risk approach was developed for diabetic complications and risk of cardiovascular events based on the UK Prospective Diabetes Study Outcomes Model 1 equations. Baseline population characteristics reflect the PIONEER 4 trial (Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus) of oral semaglutide. Model comparators included subcutaneous semaglutide, dulaglutide, and liraglutide. Treatment effects (change in glycosylated hemoglobin, weight, and systolic blood pressure) were estimated by network meta-analysis. Drug, management, and event costs (in 2019 US dollars), survival after nonfatal events, and utilities were obtained from the literature. Costs and quality-adjusted life-year (QALY) outcomes were discounted at 3% annually over a lifetime horizon. Probabilistic and 1-way sensitivity analyses were performed. FindingsTotal estimated costs and QALYs were $144,065 and 12.98 for oral semaglutide, $145,721 and 12.96 for dulaglutide, $145,833 and 12.99 for SC semaglutide, and $149,428 and 12.97 for liraglutide, respectively. Oral semaglutide was less costly and more effective than dulaglutide and liraglutide but less costly than subcutaneous semaglutide with similar effectiveness. Oral semaglutide was favored versus subcutaneous semaglutide in 52.10% of model replications at a willingness-to-pay of $150,000 per QALY. ImplicationsOral semaglutide is predicted to offer health benefits similar to subcutaneous semaglutide and ahead of dulaglutide and liraglutide. Oral semaglutide is a cost-effective glucagon-like peptide 1 receptor agonist treatment option.

Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type2 Diabetes: The PIONEER10 Randomized, Active-Controlled Trial.

IntroductionIn the randomized Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) 10 trial, once-daily orally administered semaglutide—the first oral glucagon-like peptide 1 receptor agonist (GLP-1RA)—was similarly tolerated with comparable (at 7 mg) or better (at 14 mg) efficacy versus the injectable GLP-1RA dulaglutide 0.75 mg. Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.MethodsThe DTR-QoL comprises 29 questions, providing four domain and total scores. Answers were converted to a score between 0 and 100, with higher scores indicating greater HRQoL. Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients. Outcomes were assessed at weeks 26 and 52.ResultsMean baseline DTR-QoL domain scores were similar between treatment arms and were generally lower (giving more scope for improvement) for “anxiety and dissatisfaction with treatment” (62.1–65.3) and “satisfaction with treatment” (53.9–57.9) than “burden on social activities and daily activities” (76.5–77.7) and “hypoglycemia” (83.5–88.2). Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg for the total score (estimated mean change from baseline [CfB] 7.3 and 8.1 vs 3.3; estimated treatment difference [ETD] 3.9 and 4.8) and the “anxiety and dissatisfaction with treatment” domain (CfB 9.7 and 10.9 vs 3.7; ETD 6.0 and 7.2) at week 52. Orally administered semaglutide 14 mg improved the “satisfaction with treatment” domain versus dulaglutide 0.75 mg (CFB 13.8 vs 5.7; ETD 8.1). DTR-QoL scores for orally administered semaglutide tended to be more durable (sustained over time) than for dulaglutide. Outcomes for the trial product estimand were similar.ConclusionOrally administered semaglutide 7 and 14 mg improved the patients’ HRQoL measured by the Japanese-specific DTR-QoL instrument versus dulaglutide 0.75 mg at week 52.Trial registrationClinicalTrials.gov NCT03015220.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-020-00985-w.

Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11).

OBJECTIVETo compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.RESEARCH DESIGN AND METHODSPatients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks. The primary objective was determining superiority of dulaglutide 3.0 mg and/or 4.5 mg over 1.5 mg in HbA1c reduction at 36 weeks. Secondary superiority objectives included change in body weight. Two estimands addressed efficacy objectives: treatment regimen (regardless of treatment discontinuation or rescue medication) and efficacy (on treatment without rescue medication) in all randomly assigned patients.RESULTSMean baseline HbA1c and BMI in randomly assigned patients (N = 1,842) was 8.6% (70 mmol/mol) and 34.2 kg/m2, respectively. At 36 weeks, dulaglutide 4.5 mg provided superior HbA1c reductions compared with 1.5 mg (treatment-regimen estimand: −1.77 vs. −1.54% [−19.4 vs. −16.8 mmol/mol], estimated treatment difference [ETD] −0.24% (−2.6 mmol/mol), P < 0.001; efficacy estimand: −1.87 vs. −1.53% [−20.4 vs. −16.7 mmol/mol], ETD −0.34% (−3.7 mmol/mol), P < 0.001). Dulaglutide 3.0 mg was superior to 1.5 mg for reducing HbA1c, using the efficacy estimand (ETD −0.17% [−1.9 mmol/mol]; P = 0.003) but not the treatment-regimen estimand (ETD −0.10% [−1.1 mmol/mol]; P = 0.096). Dulaglutide 4.5 mg was superior to 1.5 mg for weight loss at 36 weeks for both estimands (treatment regimen: −4.6 vs. −3.0 kg, ETD −1.6 kg, P < 0.001; efficacy: −4.7 vs. −3.1 kg, ETD −1.6 kg, P < 0.001). Common adverse events through 36 weeks included nausea (1.5 mg, 13.4%; 3 mg, 15.6%; 4.5 mg, 16.4%) and vomiting (1.5 mg, 5.6%; 3 mg, 8.3%; 4.5 mg, 9.3%).CONCLUSIONSIn patients with type 2 diabetes inadequately controlled by metformin, escalation from dulaglutide 1.5 mg to 3.0 mg or 4.5 mg provided clinically relevant, dose-related reductions in HbA1c and body weight with a similar safety profile.

Evaluation of the Long-Term Cost-Effectiveness of Once-Weekly Semaglutide Versus Dulaglutide and Sitagliptin in the Spanish Setting.

Healthcare systems aim to maximize the health of the population, but must work within constrained budgets. Therefore, choosing therapies that are both effective and cost-effective is paramount. The present analysis assessed the cost-effectiveness of once-weekly semaglutide 0.5mg and 1mg versus once-weekly dulaglutide 1.5mg and versus once daily sitagliptin 100mg for the treatment of patients with type 2 diabetes with inadequate glycemic control on oral anti-hyperglycemic medications over patient lifetimes from a healthcare payer perspective in the Spanish setting. Cost and clinical outcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model. Baseline cohort characteristics and treatment effects on initiation of semaglutide 0.5mg and 1mg, dulaglutide 1.5mg and sitagliptin 100mg were based on the once-weekly semaglutide clinical trial program (SUSTAIN 7 and 2). Captured costs included treatment costs and costs of diabetes-related complications. Projected outcomes were discounted at 3.0% annually. Projections of long-term clinical outcomes indicated that once-weekly semaglutide 0.5mg and 1mg were associated with improvements in discounted life expectancy of 0.02 and 0.11years, respectively, and discounted quality-adjusted life expectancy of 0.03 and 0.11quality-adjusted life years (QALYs), respectively, versus dulaglutide 1.5mg. Compared with sitagliptin, once-weekly semaglutide 0.5mg and 1mg were associated with improvements in discounted life expectancy of 0.17 and 0.24years, respectively and discounted quality-adjusted life expectancy of 0.16 and 0.23QALYs. The increased duration and quality of life with once-weekly semaglutide 0.5mg and 1mg resulted from a reduced cumulative incidence and delayed time to onset of diabetes-related complications. Avoided complications resulted in once-weekly semaglutide 0.5mg and 1mg being cost-saving versus dulaglutide 1.5 mg and versus sitagliptin 100mg from a healthcare payer perspective. Once-weekly semaglutide 0.5mg and 1mg were considered dominant (more effective and less costly) versus sitagliptin 100mg and dulaglutide 1.5mg for the treatment of patients with type 2 diabetes with inadequate glycemic control on oral anti-hyperglycemic medications and are likely to be a good use of healthcare resources in the Spanish setting.

Effects of Semaglutide Versus Dulaglutide on Epicardial Fat Thickness in Subjects with Type 2 Diabetes and Obesity.

Background and AimsEpicardial adipose tissue (EAT), the visceral fat depot of the heart, is a modifiable cardio-metbolic risk factor and therapeutic target. Semaglutide and dulaglutide, glucagon-like peptide-1 (GLP-1) receptor agonists, are indicated for the treatment of type 2 diabetes mellitus (T2DM). GLP-1 receptor agonists have recently shown to reduce cardiovascular risk. Epicardial adipose tissue expresses GLP-1 receptors (GLP-1Rs). GLP-1 receptor agonist liraglutide is known to significantly decrease EAT thickness. However, the effects of GLP-1 receptor agonists semaglutide and dulaglutide on EAT thickness are unknown.Materials and MethodsWe performed a 12-week, controlled, parallel study in 80 subjects with T2DM and obesity. Patients received either semaglutide, up to 1 mg subcutaneous (sc) weekly, or dulaglutide, up to 1.5 mg sc weekly, as the standard of care in addition to their usual medication regimen. Twenty subjects with T2DM and obesity were started on metformin and a diet and served as the control group. Ultrasound-measured EAT thickness was measured at baseline and at the 12-week follow-up.ResultsEpicardial adipose tissue thickness significantly decreased in both semaglutide and dulaglutide groups (P < 0.001) after 12 weeks, accounting for a 20% reduction. There was no EAT reduction in the metformin group. Body mass index (BMI) and HbA1c improved in all groups without reaching statistical significance. Epicardial adipose tissue thickness reduction was significantly greater (P < 0.01) with the higher doses of semaglutide (1 mg) and dulaglutide (1.5 mg), respectively.ConclusionWeekly administration of either GLP-1 receptor agonists semaglutide or dulaglutide causes a rapid, substantial, and dose-dependent reduction in EAT thickness.

Management of Patients with Type 2 Diabetes with Once-Weekly Semaglutide Versus Dulaglutide, Exenatide ER, Liraglutide and Lixisenatide: A Cost-Effectiveness Analysis in the Danish Setting.

IntroductionOnce-weekly semaglutide is a novel glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes (T2D) that has been associated with greater reductions in glycated hemoglobin (HbA1c) and body weight versus GLP-1 receptor agonists dulaglutide, exenatide extended-release (ER), liraglutide and lixisenatide in the SUSTAIN trial program and a network meta-analysis (NMA). The aim of the present study was to assess the long-term cost-effectiveness of semaglutide versus all available GLP-1 receptor agonists in Denmark, using a clinically orientated treatment approach.MethodsOutcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model. Baseline characteristics and treatment effects were sourced from the corresponding SUSTAIN trials and the NMA. Patients were assumed to initiate GLP-1 receptor agonist therapy and subsequently treatment-intensify according to clinical treatment guidelines, with addition of basal insulin and switching to basal-bolus insulin occurring when HbA1c exceeded recommended targets. Patients were assumed to receive a GLP-1 receptor agonist plus basal insulin therapy once HbA1c levels reached 7.5% and a basal-bolus insulin regimen once HbA1c exceeded 8.0%. Costs were captured in 2017 Danish kroner (DKK), with future costs and outcomes discounted at 3% per annum.ResultsPrimary analyses indicated that semaglutide 0.5 mg and 1 mg were associated with improvements in quality-adjusted life expectancy of 0.11 and 0.34 quality-adjusted life years, respectively, versus dulaglutide, achieved at cost savings of DKK 289 and DKK 13,416, respectively. Supporting analyses indicated that both doses of semaglutide were either cost-effective or dominant versus exenatide ER, liraglutide 1.2 mg and 1.8 mg and lixisenatide.ConclusionSemaglutide represents a cost-effective alternative to other GLP-1 receptor agonist therapies available in Denmark, demonstrating clinical benefits versus dulaglutide, exenatide ER, liraglutide and lixisenatide for the treatment of patients with T2D.FundingNovo Nordisk A/S.Plain Language SummaryPlain language summary available for this article.Electronic supplementary materialThe online version of this article (10.1007/s13300-019-0630-6) contains supplementary material, which is available to authorized users.

Cost of Achieving HbA1c Treatment Targets and Weight Loss Responses with Once-Weekly Semaglutide Versus Dulaglutide in the United States.

IntroductionThe National Health and Nutrition Examination Surveys show that many people with type 2 diabetes (T2D) in the USA fail to achieve recommended treatment targets. In the SUSTAIN 7 randomized controlled trial, once-weekly semaglutide (0.5 and 1.0 mg) was superior to comparative doses of dulaglutide (0.75 and 1.5 mg) in reducing glycated hemoglobin (HbA1c) and body weight in people with T2D. The present study estimated the cost per patient achieving HbA1c treatment targets and weight loss responses with once-weekly semaglutide and dulaglutide in the USA.MethodsNumbers needed to treat and annual cost per patient achieving HbA1c targets (including a triple composite endpoint of HbA1c < 7% without hypoglycemia and no weight gain) or weight loss responses were calculated on the basis of data from SUSTAIN 7 and the annual cost of treatment from a US healthcare payer perspective.ResultsMore patients reached HbA1c targets with once-weekly semaglutide than with dulaglutide, and once-weekly semaglutide showed lower costs of control for all modeled endpoints. The cost per patient achieving the triple composite endpoint was USD 11,916 with once-weekly semaglutide 1.0 mg and USD 15,204 with dulaglutide 1.5 mg, representing a 28% larger cost with dulaglutide 1.5 mg. The cost of reaching the target was 68% larger with dulaglutide 0.75 mg versus once-weekly semaglutide 0.5 mg. For each patient achieving an HbA1c < 7%, the cost would be 18% larger with dulaglutide 1.5 mg than with once-weekly semaglutide 1.0 mg.ConclusionsThe cost of bringing one patient to the triple composite endpoint of an HbA1c < 7% without hypoglycemia and no weight gain would be 28% and 68% higher with dulaglutide 1.5 mg relative to once-weekly semaglutide 1.0 mg and dulaglutide 0.75 mg relative to once-weekly semaglutide 0.5 mg, respectively. Once-weekly semaglutide therefore provides better value for money than dulaglutide for the treatment of people with T2D in the USA.FundingNovo Nordisk A/S.