Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial

Gao, Leili; Lee, Byung Wan; Chawla, Manoj; Kim, Joshua; Huo, Li; Du, Liying; Huang, Yuandong; Ji, Linong

doi:10.1038/s41591-023-02344-1

Cited by 36 publications

(55 citation statements)

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“…In addition, tirzepatide was generally well tolerated across the BMI subgroups, with a similar safety profile to that previously reported. [9][10][11][12][13][14][15][16][17] In the present analysis, the majority of participants (63%-94%) receiving tirzepatide achieved HbA1c <7.0%, with numerically higher rates among the higher BMI subgroup (≥30 kg/m 2 ) with tirzepatide 10 or 15 mg (>88%). In addition, HbA1c ≤6.5% and normoglycaemia (HbA1c <5.7%) were achieved by up to 79% and 34% of participants receiving tirzepatide, respectively, across all BMI subgroups.…”

Section: Discussionmentioning

confidence: 94%

“…In general, the safety profile of tirzepatide in the present analysis was consistent with the findings of the SURPASS trials. [9][10][11][12][13][14][15][16][17] Participants with a BMI of 30 kg/m 2 or higher who received tirzepatide tended to have a lower rate of discontinuations due to AEs compared with participants with a lower BMI. However, this participant subgroup also had a younger mean age and a shorter mean duration of diabetes, which may have influenced the safety profile.…”

Section: Discussionmentioning

confidence: 99%

“…This was an exploratory subgroup analysis of SURPASS-AP-Combo, a 40-week, open-label, multicentre, randomized, parallel-group, Phase 3 trial (ClinicalTrials.gov registration: NCT04093752). The detailed study design and primary results have been published previously 14 ; the trial design is summarized in Figure S1. The study was conducted across 66 sites in China, South Korea, Australia and India.…”

Section: Methodsmentioning

confidence: 99%

“…[6][7][8] Results from the SURPASS clinical trials have shown that tirzepatide promotes glucose lowering and weight reduction, and has an acceptable safety profile compared with placebo, GLP-1 receptor agonists and insulins in people with T2D across a range of disease durations and treatment backgrounds. [9][10][11][12][13][14][15][16] SURPASS-AP-Combo was the first multicentre, Phase 3 clinical trial to investigate the efficacy and safety of tirzepatide versus insulin glargine in an Asia-Pacific, predominantly Chinese, population with T2D and inadequate glycaemic control on a stable dose of metformin with or without a sulphonylurea. 14 Consistent results in glucose-lowering and weight-reduction effects were reported in SURPASS-AP-Combo 14 and the global SUR-PASS trials.…”

mentioning

confidence: 99%

“…9,10,12,13,15,16 According to World Health Organization (WHO) criteria, the majority of participants enrolled in the global SURPASS studies had T2D and obesity, 9,10,12,13,15,16 whereas those enrolled in SURPASS-AP-Combo had a relatively low body mass index (BMI). 14 Further investigation of the efficacy and safety of tirzepatide in people with T2D and different BMIs is needed. Here, we present the findings from a subgroup analysis of the SURPASS-AP-Combo study, in which we assessed the efficacy and safety of tirzepatide versus insulin glargine according to baseline BMI in people from the Asia-Pacific region with T2D.…”

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confidence: 99%

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Efficacy and safety of tirzepatide in people with type 2 diabetes by baseline body mass index: An exploratory subgroup analysis of SURPASS‐AP‐Combo

Ma,

Liu,

Wang

et al. 2024

Diabetes Obesity Metabolism

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AimsTo assess the efficacy and safety of tirzepatide versus insulin glargine in people with type 2 diabetes (T2D) by baseline body mass index (BMI).Materials and MethodsParticipants with T2D from the Phase 3 SURPASS‐AP‐Combo trial (NCT04093752) were categorized into three BMI subgroups (normal weight [<25 kg/m2], overweight [≥25 and <30 kg/m2], and obese [≥30 kg/m2]) according to World Health Organization criteria. Exploratory outcomes including glycaemic control, body weight, cardiometabolic risk, and safety were compared among three tirzepatide doses (5, 10 or 15 mg) and insulin glargine.ResultsOf 907 participants, 235 (25.9%) had a BMI <25 kg/m2, 458 (50.5%) a BMI ≥25 to <30 kg/m2, and 214 (23.6%) a BMI ≥30 kg/m2 at baseline. At Week 40, all tirzepatide doses led to a greater reduction in mean glycated haemoglobin (HbA1c; −2.0% to −2.8% vs. −0.8% to −1.0%, respectively) and percent change in body weight (−5.5% to −10.8% vs. 1.0% to 2.5%, respectively) versus insulin glargine, across the BMI subgroups. Compared with insulin glargine, a higher proportion of tirzepatide‐treated participants achieved treatment goals for HbA1c and body weight reduction. Improvements in other cardiometabolic indicators were also observed with tirzepatide across all the BMI subgroups. The safety profile of tirzepatide was similar across all subgroups by BMI. The most frequent adverse events with tirzepatide were gastrointestinal‐related events and decreased appetite, with relatively few events leading to treatment discontinuation.ConclusionsIn participants with T2D, regardless of baseline BMI, treatment with tirzepatide resulted in statistically significant and clinically meaningful glycaemic reductions and body weight reductions compared with insulin glargine, with a safety profile consistent with previous reports.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Efficacy and safety of tirzepatide in people with type 2 diabetes by baseline body mass index: An exploratory subgroup analysis of SURPASS‐AP‐Combo

Ma,

Liu,

Wang

et al. 2024

Diabetes Obesity Metabolism

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Tirzepatide for Weight Reduction in Chinese Adults With Obesity

Zhao,

Cheng,

et al. 2024

JAMA

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ImportanceObesity has become a global public health concern and China has the largest number of affected people worldwide.ObjectiveTo assess the efficacy and safety of treatment with tirzepatide for weight reduction in Chinese adults with obesity or overweight and weight-related comorbidities.Design, Setting, and ParticipantsThis randomized, double-blind, placebo-controlled, phase 3 clinical trial conducted at 29 centers in China from September 2021 to December 2022 included Chinese adults (aged ≥18 years) with a body mass index (BMI) greater than or equal to 28 or greater than or equal to 24 and at least 1 weight-related comorbidity, excluding diabetes.InterventionsParticipants were randomly assigned (1:1:1) to receive once-weekly, subcutaneous 10-mg (n = 70) or 15-mg (n = 71) tirzepatide or placebo (n = 69), plus a lifestyle intervention, for 52 weeks.Main Outcomes and MeasuresCo–primary end points were the percent change in body weight from baseline and weight reduction of at least 5% at week 52. Efficacy and safety analyses were performed on an intention-to-treat population.ResultsOf 210 randomized participants (103 [49.0%] female; mean [SD] age, 36.1 [9.1] years; body weight, 91.8 [16.0] kg; BMI, 32.3 [3.8]), 201 (95.7%) completed the trial. The mean change in body weight at week 52 was −13.6% (95% CI, −15.8% to −11.4%) with tirzepatide 10 mg, −17.5% (95% CI, −19.7% to −15.3%) with tirzepatide 15 mg, and −2.3% with placebo (difference between 10 mg and placebo, −11.3% [95% CI, −14.3% to −8.3%; P &lt; .001]; difference between 15 mg and placebo, −15.1% [95% CI, −18.2% to −12.1%; P &lt; .001]). The percentage of participants achieving body weight reductions of 5% or greater was 87.7% with tirzepatide 10 mg, 85.8% with tirzepatide 15 mg, and 29.3% with placebo (P &lt; .001 for comparisons with placebo). The most frequent treatment-emergent adverse events with tirzepatide were gastrointestinal. Most were mild to moderate in severity, with few events leading to treatment discontinuation (&lt;5%).Conclusions and RelevanceIn Chinese adults with obesity or overweight, once-weekly treatment with tirzepatide 10 mg or 15 mg resulted in statistically significant and clinically meaningful weight reduction with an acceptable safety profile.Trial RegistrationClinicalTrials.gov Identifier: NCT05024032

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Characterization of tirzepatide‐treated patients achieving different glycemic control levels in SURPASS‐AP‐Combo

Bao,

Han,

et al. 2024

Obesity

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ObjectiveThe study objective was to characterize subgroups of Asia‐Pacific patients with type 2 diabetes who achieved different glycated hemoglobin (HbA1c) targets on tirzepatide treatment.MethodsThis was a post hoc analysis of the SURPASS AP‐Combo study. Baseline characteristics, changes in metabolic markers, and safety were compared between tirzepatide‐treated patients achieving HbA1c <7.0% (<53 mmol/mol) and those achieving ≥7.0% (≥53 mmol/mol) at week 40. Among patients achieving HbA1c <7.0% (<53 mmol/mol), further comparisons were conducted among subgroups achieving HbA1c <5.7% (<39 mmol/mol), 5.7% to 6.5% (39 to 48 mmol/mol), and >6.5% to <7.0% (>48 to <53 mmol/mol).ResultsFive hundred ninety‐eight patients on tirzepatide treatment without rescue medication were included (56.9% male; mean age: 53.1 years; mean baseline HbA1c: 8.7% [71.6 mmol/mol]). Patients achieving HbA1c <7.0% (<53 mmol/mol) versus ≥7.0% (≥53 mmol/mol) were slightly younger with a shorter disease duration and lower HbA1c at baseline, and they had greater improvements in HbA1c, fasting serum glucose, body weight, BMI, waist circumference, waist‐height ratio, diastolic blood pressure, lipids, and self‐monitored blood glucose at week 40. Patients achieving HbA1c <5.7% (<39 mmol/mol) versus those achieving 5.7% to 6.5% (39 to 48 mmol/mol) and those achieving >6.5% to <7.0% (>48 to <53 mmol/mol) were much younger, had much lower HbA1c, and had further improvements in metabolic markers. Tirzepatide treatment was well tolerated irrespective of the HbA1c level achieved, with a low incidence of hypoglycemic events.ConclusionsThese findings may help to inform clinical decisions in Asia‐Pacific patients with type 2 diabetes.

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Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial

Cited by 36 publications

References 33 publications

Efficacy and safety of tirzepatide in people with type 2 diabetes by baseline body mass index: An exploratory subgroup analysis of SURPASS‐AP‐Combo

Efficacy and safety of tirzepatide in people with type 2 diabetes by baseline body mass index: An exploratory subgroup analysis of SURPASS‐AP‐Combo

Tirzepatide for Weight Reduction in Chinese Adults With Obesity

Characterization of tirzepatide‐treated patients achieving different glycemic control levels in SURPASS‐AP‐Combo

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