Abstract:Background: We aimed to compare the effect of repaglinide and metformin monotherapy as an initial therapy in Chinese patients with newly diagnosed type 2 diabetes mellitus (T2DM). Patients and methods: In this 15-week, open-labelled, parallel-controlled, randomised study, 60 Chinese drug-naive patients with newly diagnosed T2DM were randomised (2:1) to receive repaglinide or metformin monotherapy. Primary endpoint was change in HbA1c from baseline to the end of the trial. Secondary endpoints included changes i… Show more
“…Of these seven papers, using simple critical appraisal tools such as PICO [13] and CASP [14], it is clear that three [15][16][17] should not have been included in the analysis. The third paper is a small pilot study from China [17]. The third paper is a small pilot study from China [17].…”
Section: Currentmentioning
confidence: 99%
“…Two from Pakistan appear to report on the same cohort of 100 patients [15,16] inflating the numbers in the network meta-analyses and raising probity issues in these papers. The drug dosage comparators in all seven repaglinide studies [15][16][17][18][19][20][21] also make any sensible comparison difficult because doses ranged from 1.5 to 16 mg, whereas there were only three dose steps for the sulfonylurea glibenclamide. All three studies are underpowered, open to treatment bias in their design and the population cohorts bear no relationship to the UK given that the patients are much younger and with a much lower BMI and much higher HbA 1c than found in the average south Asian UK patient with Type 2 diabetes.…”
Section: Currentmentioning
confidence: 99%
“…Considering the case of repaglinide, taken from the references provided by NICE [1], there appear to be seven papers on monotherapy with repaglinide of which four have been published since CG87. Of these seven papers, using simple critical appraisal tools such as PICO [13] and CASP [14], it is clear that three [15][16][17] should not have been included in the analysis. Two from Pakistan appear to report on the same cohort of 100 patients [15,16] inflating the numbers in the network meta-analyses and raising probity issues in these papers.…”
Revised Type 2 diabetes guidelines (June 2015) have been released for further consultation after pressure from healthcare professionals and other stakeholders [1][2][3][4].
What NICE proposesThe National Institute for Health and Care Excellence (NICE) sets out a structure for the management of Type 2 diabetes. Advice is provided on appropriate lifestyle changes, including diet, exercise and patient education. It is proposed that oral monotherapy (metformin) be introduced when HbA 1c increases beyond 48 mmol/mol (6.5%). Failure to achieve that target should lead to the introduction of combination therapy at HbA 1c ≥ 58 mmol/mol (≥ 7.5%). Glucose monitoring should be limited to those on drugs that cause hypoglycaemia and be supported by regular auditing. The sequence of therapy proposed in the first draft ran: metformin, repaglinide, pioglitazone and then alternative fourth-line choices. In the revised proposal, the sequence runs, at least in the body of the text, as metformin then a choice of repaglinide, pioglitazone, sulfonylureas and dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins). These are followed by glucagon-like peptide 1 (GLP-1) receptor agonists and insulin. GLP-1 receptor agonists are to be considered only when the BMI is greater than prescribed levels (35 kg/m 2 ) or at lower BMI depending on ethnicity and risk assessment regarding weight loss benefit. Insulin is to be given as regular human insulin (isophane) for patients with Type 2 diabetes. Sodium/ glucose co-transporter 2 (SGLT-2) inhibitors are not formally included in the algorithm because HTA guidance is awaited later in the year.
“…Of these seven papers, using simple critical appraisal tools such as PICO [13] and CASP [14], it is clear that three [15][16][17] should not have been included in the analysis. The third paper is a small pilot study from China [17]. The third paper is a small pilot study from China [17].…”
Section: Currentmentioning
confidence: 99%
“…Two from Pakistan appear to report on the same cohort of 100 patients [15,16] inflating the numbers in the network meta-analyses and raising probity issues in these papers. The drug dosage comparators in all seven repaglinide studies [15][16][17][18][19][20][21] also make any sensible comparison difficult because doses ranged from 1.5 to 16 mg, whereas there were only three dose steps for the sulfonylurea glibenclamide. All three studies are underpowered, open to treatment bias in their design and the population cohorts bear no relationship to the UK given that the patients are much younger and with a much lower BMI and much higher HbA 1c than found in the average south Asian UK patient with Type 2 diabetes.…”
Section: Currentmentioning
confidence: 99%
“…Considering the case of repaglinide, taken from the references provided by NICE [1], there appear to be seven papers on monotherapy with repaglinide of which four have been published since CG87. Of these seven papers, using simple critical appraisal tools such as PICO [13] and CASP [14], it is clear that three [15][16][17] should not have been included in the analysis. Two from Pakistan appear to report on the same cohort of 100 patients [15,16] inflating the numbers in the network meta-analyses and raising probity issues in these papers.…”
Revised Type 2 diabetes guidelines (June 2015) have been released for further consultation after pressure from healthcare professionals and other stakeholders [1][2][3][4].
What NICE proposesThe National Institute for Health and Care Excellence (NICE) sets out a structure for the management of Type 2 diabetes. Advice is provided on appropriate lifestyle changes, including diet, exercise and patient education. It is proposed that oral monotherapy (metformin) be introduced when HbA 1c increases beyond 48 mmol/mol (6.5%). Failure to achieve that target should lead to the introduction of combination therapy at HbA 1c ≥ 58 mmol/mol (≥ 7.5%). Glucose monitoring should be limited to those on drugs that cause hypoglycaemia and be supported by regular auditing. The sequence of therapy proposed in the first draft ran: metformin, repaglinide, pioglitazone and then alternative fourth-line choices. In the revised proposal, the sequence runs, at least in the body of the text, as metformin then a choice of repaglinide, pioglitazone, sulfonylureas and dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins). These are followed by glucagon-like peptide 1 (GLP-1) receptor agonists and insulin. GLP-1 receptor agonists are to be considered only when the BMI is greater than prescribed levels (35 kg/m 2 ) or at lower BMI depending on ethnicity and risk assessment regarding weight loss benefit. Insulin is to be given as regular human insulin (isophane) for patients with Type 2 diabetes. Sodium/ glucose co-transporter 2 (SGLT-2) inhibitors are not formally included in the algorithm because HTA guidance is awaited later in the year.
“…With respect to the result that PINS decreased in the TT genotype group while it increased in the CC and CT genotype groups, several possible reasons are listed as follows. First, in addition to stimulating the release of insulin, repaglinide can improve insulin resistance after treatment (Fang et al, ; Li et al, ). Besides, insulin resistance is associated with exposure to high levels of insulin closely (Shanik et al, ).…”
Section: Discussionmentioning
confidence: 99%
“…In the present study, the differential values of HOMA-IR is 21. (Fang et al, 2014;Li et al, 2007). Besides, insulin resistance is associated with exposure to high levels of insulin closely (Shanik et al, 2008 to study the effect of GRK5 rs10886471 polymorphism on the therapeutic efficacy of repaglinide with larger sample size in the following work.…”
Post-Market Research We aimed to investigate the impact of G protein-coupled receptor kinase 5 (GRK5) rs10886471 polymorphism on repaglinide efficacy in Chinese patients with type 2 diabetes mellitus (T2DM). A total of 300 T2DM patients and 210 healthy controls were genotyped for GRK5 rs10886471 on a three-dimensional polyacrylamide gel-based DNA microarray. Eighty-five patients with the same genotypes of cytochrome P450 (CYP) 2C8*3 139Arg and organic anion-transporting polypeptide 1B1 (OATP1B1) 521TT were randomly selected to orally take repaglinide for eight consecutive weeks. Then, the biochemical indicators and pharmacodynamic parameters were measured before and after repaglinide treatment. The T allelic frequency of GRK5 rs10886471 was higher in T2DM patients than in healthy subjects (p < .01). T2DM patients with genotypes CC and CT at GRK5 rs10886471 had a significant reduction in terms of fasting plasma glucose (FPG) compared with those with genotype TT (p < .01). In addition, the carriers of genotypes CC and CT at GRK5 rs10886471 had higher differential values of postprandial serum insulin (PINS) compared with genotype TT carriers (p < .05). These findings suggest that GRK5 rs10886471 polymorphism may influence the therapeutic efficacy of repaglinide in Chinese Han T2DM patients.
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