Efficacy and safety of saxagliptin in combination with metformin as initial therapy in <scp>C</scp>hinese patients with type 2 diabetes: <scp>R</scp>esults from the <scp>START</scp> study, a multicentre, randomized, double‐blind, active‐controlled, phase 3 trial

Dou, Jingtao; Ma, Jianhua; Liu, Jun; Wang, Changjiang; Johnsson, Eva; Yao, Hui; Zhao, June; Pan, Changyu

doi:10.1111/dom.13117

Cited by 19 publications

(20 citation statements)

References 20 publications

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“…The efficacy and safety of saxagliptin as monotherapy or combination therapy in Chinese patients with type 2 diabetes have been established in several studies 9‐12 . In the present study, saxagliptin as add‐on to metformin has shown consistent glycemic efficacy across a range of patient profiles.…”

Section: Discussionsupporting

confidence: 54%

Impact of baseline characteristics on glycemic effects of add‐on saxagliptin or acarbose to metformin therapy: Subgroup analysis of the SMART study in Chinese patients with type 2 diabetes mellitus

Fang

et al. 2020

J of Diabetes Invest

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Aims/Introduction: This secondary analysis of the 24-week SMART study examined the efficacy of add-on saxagliptin or acarbose to metformin across different patient subgroups with type 2 diabetes mellitus, based on baseline characteristics. Materials and Methods: Randomized patients (n = 481) were classified into subgroups based on their baseline age (<65, ≥65 years), body mass index (BMI; <24, 24-<28, ≥28 kg/m 2), glycated hemoglobin (HbA1c; <8%, 8-<9%, 9-<10%, ≥10%) and renal function (creatinine clearance 50-<80, ≥80 mL/min). Treatment effects on primary outcome (HbA1c) and key secondary outcomes of fasting plasma glucose (FPG), 2-h postprandial glucose and homeostatic model assessment of b-cell function were assessed across patient subgroups. Results: For saxagliptin, reductions in HbA1c from baseline to week 24 were consistent across different subgroups regardless of baseline age, body mass index, HbA1c and renal function (range-0.66 to-1.16%). Saxagliptin was associated with consistent reductions in FPG (-0.60 to-1.33 mmol/L) and 2-h postprandial glucose (-0.48 to-1.95 mmol/L) across the majority of subgroups studied. The efficacy of acarbose on FPG attenuated progressively with increasing baseline HbA1c (+0.86 to-1.43 mmol/L); an increase from baseline FPG was observed in patients with HbA1c >9%. The effect of acarbose on postprandial glucose was also variable (+0.23 to-3.38 mmol/L). Conclusions: As add-on to metformin, both saxagliptin and acarbose reduced HbA1c regardless of baseline HbA1c, age, body mass index and renal function; however, only saxagliptin was effective at a stable glycemic control (FPG and PPG). The efficacy of acarbose on FPG and PPG was significantly attenuated in patients with higher baseline HbA1c (≥8%). diabetes worldwide, with a prevalence of 10.9% (114 million) among adults aged 20-79 years; approximately 90% of these patients have type 2 diabetes 1. The high prevalence of type 2 diabetes and the corresponding costs of its associated complications place a considerable strain on China's public health services 1-3 .

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Section: Discussionsupporting

confidence: 54%

Impact of baseline characteristics on glycemic effects of add‐on saxagliptin or acarbose to metformin therapy: Subgroup analysis of the SMART study in Chinese patients with type 2 diabetes mellitus

Fang

et al. 2020

J of Diabetes Invest

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“…We included 82 randomised controlled trials (fig 1) with 104 833 participants with type 2 diabetes in the traditional pairwise meta-analysis 343536373839404142434445464748495051525354555657585960616263646566676869707172737475767778798081828384858687888990919293949596979899100101102103104105106107108109110111112113114115. Characteristics of studies and participants included in the pairwise meta-analysis are shown in table 1 and supplementary table C. The average age of participants was 59.4 years, and 39.7% (n=41 618) were female.…”

Section: Resultsmentioning

confidence: 99%

Dipeptidyl peptidase-4 inhibitors and gallbladder or biliary disease in type 2 diabetes: systematic review and pairwise and network meta-analysis of randomised controlled trials

Wang

Ping

et al. 2022

BMJ

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ObjectiveTo examine the association between dipeptidyl peptidase-4 inhibitors and gallbladder or biliary diseases.DesignSystematic review and pairwise and network meta-analysis.Data sourcesPubMed, EMBASE, Web of Science, and CENTRAL from inception until 31 July 2021.Eligibility criteriaRandomised controlled trials of adult patients with type 2 diabetes who received dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, and sodium-glucose cotransporter-2 inhibitors compared with placebo or other antidiabetes drugs.Main outcome measuresComposite of gallbladder or biliary diseases, cholecystitis, cholelithiasis, and biliary diseases.Data extraction and data synthesisTwo reviewers independently extracted the data and assessed the quality of the studies. The quality of the evidence for each outcome was assessed using the Grading of Recommendations, Assessment, Development and Evaluations framework (GRADE) approach. The meta-analysis used pooled odds ratios and 95% confidence intervals.ResultsA total of 82 randomised controlled trials with 104 833 participants were included in the pairwise meta-analysis. Compared with placebo or non-incretin drugs, dipeptidyl peptidase-4 inhibitors were significantly associated with an increased risk of the composite of gallbladder or biliary diseases (odds ratio 1.22 (95%confidence interval 1.04 to 1.43); risk difference 11 (2 to 21) more events per 10 000 person years) and cholecystitis (odds ratio 1.43 (1.14 to 1.79); risk difference 15 (5 to 27) more events per 10 000 person years) but not with the risk of cholelithiasis and biliary diseases. The associations tended to be observed in patients with a longer duration of dipeptidyl peptidase-4 inhibitor treatment. In the network meta-analysis of 184 trials, dipeptidyl peptidase-4 inhibitors increased the risk of the composite of gallbladder or biliary diseases and cholecystitis compared with sodium-glucose cotransporter-2 inhibitors but not compared with glucagon-like peptide-1 receptor agonists.ConclusionsDipeptidyl peptidase-4 inhibitors increased the risk of cholecystitis in randomised controlled trials, especially with a longer treatment duration, which requires more attention from physicians in clinical practice.Systematic review registrationPROSPERO CRD42021271647.

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“…In the present study, db mice (12~16 weeks age) showed such a very high glucose state in severe diabetes that metformin did not recover blood glucose to normal level. Accordingly, the initial treatment dose at 10 mg/kg in db mice, equivalent of 600 mg/60 kg (commercially sold Diabex TM at a dose of 500 mg/kg/day or 1,000 mg/kg/day) ( 14 ) in men, might not be sufficient enough to lower the blood glucose level. Metformin is widely used as a hypoglycemic reagent for type 2 diabetes.…”

Section: Discussionmentioning

confidence: 99%

Anti-Diabetic Effects of Dung Beetle Glycosaminoglycan on db Mice and Gene Expression Profiling

et al. 2018

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Anti-diabetes activity of Catharsius molossus (Ca, a type of dung beetle) glycosaminoglycan (G) was evaluated to reduce glucose, creatinine kinase, triglyceride and free fatty acid levels in db mice. Diabetic mice in six groups were administrated intraperitoneally: Db heterozygous (Normal), Db homozygous (CON), Heuchys sanguinea glycosaminoglycan (HEG, 5 mg/kg), dung beetle glycosaminoglycan (CaG, 5 mg/kg), bumblebee (Bombus ignitus) queen glycosaminoglycan (IQG, 5 mg/kg) and metformin (10 mg/kg), for 1 month. Biochemical analyses in the serum were evaluated to determine their anti-diabetic and anti-inflammatory actions in db mice after 1 month treatment with HEG, CaG or IQG treatments. Blood glucose level was decreased by treatment with CaG. CaG produced significant anti-diabetic actions by inhiting creatinine kinase and alkaline phosphatase levels. As diabetic parameters, serum glucose level, total cholesterol and triglyceride were significantly decreased in CaG5-treated group compared to the controls. Dung beetle glycosaminoglycan, compared to the control, could be a potential therapeutic agent with anti-diabetic activity in diabetic mice. CaG5-treated group, compared to the control, showed the up-regulation of 48 genes including mitochondrial yen coded tRNA lysine (mt-TK), cytochrome P450, family 8/2, subfamily b, polypeptide 1 (Cyp8b1), and down-regulation of 79 genes including S100 calcium binding protein A9 (S100a9) and immunoglobulin kappa chain complex (Igk), and 3-hydroxy-3-methylglutaryl-CoenzymeAsynthase1 (Hmgcs1). Moreover, mitochondrial thymidine kinase (mt-TK), was up-regulated, and calgranulin A (S100a9) were down-regulated by CaG5 treatment, indicating a potential therapeutic use for anti-diabetic agent.

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Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double‐blind, active‐controlled, phase 3 trial

Abstract: Saxagliptin 5 mg plus metformin significantly improved glycaemic control compared with either monotherapy in treatment-naïve Chinese patients with type 2 diabetes, and was well tolerated.

Cited by 19 publications

References 20 publications

Impact of baseline characteristics on glycemic effects of add‐on saxagliptin or acarbose to metformin therapy: Subgroup analysis of the SMART study in Chinese patients with type 2 diabetes mellitus

Impact of baseline characteristics on glycemic effects of add‐on saxagliptin or acarbose to metformin therapy: Subgroup analysis of the SMART study in Chinese patients with type 2 diabetes mellitus

Dipeptidyl peptidase-4 inhibitors and gallbladder or biliary disease in type 2 diabetes: systematic review and pairwise and network meta-analysis of randomised controlled trials

Anti-Diabetic Effects of Dung Beetle Glycosaminoglycan on db Mice and Gene Expression Profiling

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