Efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes uncontrolled with sulphonylurea or sulphonylurea‐metformin therapy: a randomized, double‐blind study (T‐emerge 6)

Pratley, Richard E.; Urosevic, Dragan; Boldrin, Mark; Balena, R.

doi:10.1111/dom.12009

Cited by 19 publications

(15 citation statements)

References 19 publications

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“…After screening titles and abstracts, we retrieved 468 reports for full text screening. Fifty nine studies, including 55 randomised controlled trials36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 (40 from journals and 15 from the trial registry) reported in 61 reports, three cohort studies,91 92 93 and one case-control study94 were eligible for inclusion (fig 1). Eight months after our formal search (November 2013), however, an additional large case-control study95 was published.…”

Section: Resultsmentioning

confidence: 99%

Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies

Shen

Bała

et al. 2014

BMJ

212

142

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Objective To investigate the risk of pancreatitis associated with the use of incretin-based treatments in patients with type 2 diabetes mellitus.Design Systematic review and meta-analysis.Data sources Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov.Eligibility criteria Randomised and non-randomised controlled clinical trials, prospective or retrospective cohort studies, and case-control studies of treatment with glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors in adults with type 2 diabetes mellitus compared with placebo, lifestyle modification, or active anti-diabetic drugs.Data collection and analysis Pairs of trained reviewers independently screened for eligible studies, assessed risk of bias, and extracted data. A modified Cochrane tool for randomised controlled trials and a modified version of the Newcastle-Ottawa scale for observational studies were used to assess bias. We pooled data from randomised controlled trials using Peto odds ratios, and conducted four prespecified subgroup analyses and a post hoc subgroup analysis. Because of variation in outcome measures and forms of data, we describe the results of observational studies without a pooled analysis.Results 60 studies (n=353 639), consisting of 55 randomised controlled trials (n=33 350) and five observational studies (three retrospective cohort studies, and two case-control studies; n=320 289) were included. Pooled estimates of 55 randomised controlled trials (at low or moderate

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Section: Resultsmentioning

confidence: 99%

Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies

Shen

Bała

et al. 2014

BMJ

212

142

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“…Our literature search yielded 11,441 reports; 821 were potentially eligible after title and abstract screening, and 25 studies proved eligible after full text screening. These included 21 RCTs involving 18,270 patients from 30 reports [ 15 , 16 , 38 – 65 ] and four observational studies [ 17 – 19 , 66 ] involving 111,029 patients (three cohort studies and one nested case–control study) (Fig. 1 ).…”

Section: Resultsmentioning

confidence: 99%

Glucagon-like peptide-1 receptor agonists and heart failure in type 2 diabetes: systematic review and meta-analysis of randomized and observational studies

Liu

et al. 2016

BMC Cardiovasc Disord

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BackgroundThe effect of glucagon-like peptide-1(GLP-1) receptor agonists on heart failure remains uncertain. We therefore conducted a systematic review to assess the possible impact of GLP-1 agonists on heart failure or hospitalization for heart failure in patients with type 2 diabetes.MethodsWe searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov to identify randomized controlled trials (RCTs) and observational studies that addressed the effect of GLP-1 receptor agonists in adults with type 2 diabetes, and explicitly reported heart failure or hospitalization for heart failure. Two paired reviewers screened reports, collected data, and assessed the risk of bias. We pooled data from RCTs and observational studies separately, and used the GRADE approach to rate the quality of evidence.ResultsWe identified 25 studies that were eligible for our review; 21 RCTs (n = 18,270) and 4 observational studies (n = 111,029). Low quality evidence from 20 RCTs suggested, if anything, a lower incidence of heart failure between GLP-1 agonists versus control (17/7,441 vs. 19/4,317; odds ratio (OR) 0.62, 95 % confidence interval (CI) 0.31 to 1.22; risk difference (RD) 19 fewer, 95 % CI 34 fewer to 11 more per 1000 over 5 years). Three cohort studies comparing GLP-1 agonists to alternative agents provided very low quality evidence that GLP-1 agonists do not increase the incidence of heart failure. One RCT provided moderate quality evidence that GLP-1 agonists were not associated with hospitalization for heart failure (lixisenatide vs placebo: 122/3,034 vs. 127/3,034; adjusted hazard ratio 0.96, 95 % CI 0.75 to 1.23; RD 4 fewer, 95 % CI 25 fewer to 23 more per 1000 over 5 years) and a case–control study provided very low quality evidence also suggesting no association (GLP-1 agonists vs. other anti-hyperglycemic drugs: 1118 cases and 17,626 controls, adjusted OR 0.67, 95 % CI 0.32 to 1.42).ConclusionsThe current evidence suggests that GLP-1 agonists do not increase the risk of heart failure or hospitalization for heart failure among patients with type 2 diabetes.Electronic supplementary materialThe online version of this article (doi:10.1186/s12872-016-0260-0) contains supplementary material, which is available to authorized users.

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“…The T‐Emerge programme included a total of nine phase III RCTs of taspoglutide versus control for the treatment of type 2 diabetes. The methods of participant screening, study duration, standard operating procedures and inclusion and exclusion criteria were broadly similar for the T‐Emerge RCTs 1–7 (BC20750, BC21625, BC20963, BC21713, BC20965, BC21893 and BC22092) . The same cardiovascular endpoints prespecified in the Endpoint Committee Charter were used for the analysis of all studies (see below), and these were in turn adjudicated by a blinded event adjudication committee (chaired by J. R. P.).…”

Section: Methodsmentioning

confidence: 99%

Cardiovascular safety of the glucagon‐like peptide‐1 receptor agonist taspoglutide in people with type 2 diabetes: an individual participant data meta‐analysis of randomized controlled trials

Seshasai

Bennett

Petrie

et al. 2015

Diabetes Obesity Metabolism

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Efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes uncontrolled with sulphonylurea or sulphonylurea‐metformin therapy: a randomized, double‐blind study (T‐emerge 6)

Cited by 19 publications

References 19 publications

Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies

Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies

Glucagon-like peptide-1 receptor agonists and heart failure in type 2 diabetes: systematic review and meta-analysis of randomized and observational studies

Cardiovascular safety of the glucagon‐like peptide‐1 receptor agonist taspoglutide in people with type 2 diabetes: an individual participant data meta‐analysis of randomized controlled trials

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