Abstract:
AIMS/HYPOTHESIS:This long-term study was designed to further characterise the retinal safety profile of insulin glargine and human neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes mellitus. METHODS:An open-label, 5 year, randomised (1:1), multicentre, stratified, parallel-group study conducted in the USA and Canada enrolled individuals with type 2 diabetes and either no or non-proliferative retinopathy (less than severe; Early Treatment Diabetic Retinopathy Study [ETDRS] level less than 53 in both eyes) who were treated with oral hypoglycaemic agents (OHAs) alone, insulin alone or OHAs with insulin for >/=3 months prior to study entry and a baseline HbA(1c) level of 6.0-12.0%. Patients were randomised by the investigator according to the centralised interactive voice response system to receive twice-daily NPH insulin (n = 509) or once-daily basal insulin glargine (n = 515). The investigator was not blinded to the treatment group to which each participant had been assigned. The main objective of this study was to compare the progression of diabetic retinopathy between treatment groups by analysing the percentage of patients with three or more step progression in the ETDRS retinopathy patient-level severity scale after treatment with either basal insulin. Masked, centralised grading of seven-field stereoscopic fundus photographs was used. RESULTS:Similarly sustained glycaemic control was observed in both the insulin glargine and NPH insulin treatment groups. Despite a slightly greater severity of diabetic retinopathy for the insulin glargine group at baseline, three or more step progression in ETDRS score from baseline to end-of-study was similar between treatment groups (14.2% [53/374] of insulin glargine-treated patients vs 15.7% [57/363] of NPH-treated patients); the difference in the incidence of progression was -1.98% (95% CI -7.02, 3.06%). Other measures of retinopathy-the development of proliferative diabetic retinopathy and progression to clinically significant macular oedema-occurred to a similar degree in both treatment groups. No other safety issues, such as unexpected adverse events for either insulin emerged during the 5 year study. However, NPH insulin treatment was associated with a higher incidence of severe hypoglycaemia compared with insulin glargine. CONCLUSIONS/INTERPRETATION:This study shows no evidence of a greater risk of the development or progression of diabetic retinopathy with insulin glargine vs NPH insulin treatment in patients with type 2 diabetes mellitus. TRIAL REGISTRATION:ClinicalTrials.gov NCT00174824 FUNDING:This study was sponsored by sanofi-aventis.
journal_name
Diabetologiajournal_title
Diabetologiaauthors
Rosenstock J,Fonseca V,McGill JB,Riddle M,Hallé JP,Hramiak I,Johnston P,Davis Mdoi
10.1007/s00125-009-1415-7subject
Has Abstractpub_date
2009-09-01 00:00:00pages
1778-88issue
9eissn
0012-186Xissn
1432-0428journal_volume
52pub_type
杂志文章,多中心研究,随机对照试验相关文献
DIABETOLOGIA文献大全abstract:AIMS/HYPOTHESIS:The benefits of moderate alcohol consumption for type 2 diabetes have been postulated to involve a mechanism of improved insulin sensitivity. Fetuin-A, which is known to inhibit insulin signalling, has emerged as a biomarker for diabetes risk. Alcohol consumption may influence circulating fetuin-A conce...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-013-3077-8
更新日期:2014-01-01 00:00:00
abstract::The 10-year follow-up of the Munich General Practitioner Project was designed as a long-term prospective study to evaluate factors predicting macrovascular and overall mortality in a random cohort of non-insulin-dependent diabetic (NIDDM) patients. Of the original 290 patients (103 males, 187 females, median age 65 ye...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s001250050612
更新日期:1996-12-01 00:00:00
abstract:AIMS/HYPOTHESIS:Advances in type 2 diabetes genetics have raised hopes that genetic testing will improve disease prediction, prevention and treatment. Little is known about current physician and patient views regarding type 2 diabetes genetic testing. We hypothesised that physician and patient views would differ regard...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-009-1512-7
更新日期:2009-11-01 00:00:00
abstract::The presence of immunoreactive insulin in saliva and its relationship to plasma immunoreactive insulin was investigated in healthy subjects, newly diagnosed non-obese Type 2 (non-insulin-dependent) diabetic patients and obese non-diabetic subjects, basally and after an oral glucose tolerance test. The mean +/- SEM fas...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00870278
更新日期:1986-10-01 00:00:00
abstract:AIMS/HYPOTHESIS:Although insulin resistance has been associated with accumulations of specific intramuscular fatty acids and altered subcellular localisation of lipid droplets, these concepts remain controversial. Therefore, we aimed to identify specific intramuscular fatty acids and subcellular lipid localisations ass...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-014-3169-0
更新日期:2014-04-01 00:00:00
abstract::The prevalence of Type 2 (non-insulin-dependent) diabetes mellitus is high in Mauritius, a multiethnic island nation in the southwestern Indian Ocean. Evaluation of candidate genes in the different ethnic groups represents a means of assessing the genetic component. As glucokinase is known to be a key regulator of glu...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00400254
更新日期:1992-07-01 00:00:00
abstract::The insulin-like growth factor I receptor and the activity of its associated tyrosine kinase activity were characterised in wheat germ agglutinin extracts from skeletal muscle biopsies from nine control and ten obese Type 2 (non-insulin-dependent) diabetic subjects, who had marked peripheral in vivo insulin resistance...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00265369
更新日期:1988-12-01 00:00:00
abstract:AIMS/HYPOTHESIS:We assessed secular trends of cardiovascular outcomes following first diagnosis of myocardial infarction (MI) or diabetes in an unselected population. METHODS:All Danish residents aged > or = 30 years without prior diabetes or MI were identified by individual-level linkage of nationwide registers. Indi...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-010-1783-z
更新日期:2010-08-01 00:00:00
abstract:AIMS/HYPOTHESIS:We investigated whether screening for insulinoma-associated protein (IA-2) beta (IA-2beta) autoantibodies (IA-2betaA) and zinc transporter-8 (ZnT8) autoantibodies (ZnT8A) improves identification of first-degree relatives of type 1 diabetic patients with a high 5-year disease risk, which to date has been...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-009-1618-y
更新日期:2010-03-01 00:00:00
abstract:AIMS/HYPOTHESIS:Patients with glucokinase mutations are characterised by mild, persistent fasting hyperglycaemia, a small increment in glucose in response to an oral load and a dominant family history. These patients frequently present with gestational diabetes and often require insulin treatment during pregnancy. We a...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s001250050038
更新日期:2000-02-01 00:00:00
abstract:AIMS/HYPOTHESIS:Diabetic cardiomyopathy is a myocardial disease triggered by impaired insulin signalling, increased fatty acid uptake and diminished glucose utilisation. Liver X receptors (LXRs) are key transcriptional regulators of metabolic homeostasis. However, their effect in the diabetic heart is largely unknown. ...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-015-3827-x
更新日期:2016-03-01 00:00:00
abstract:AIMS/HYPOTHESIS:Enterovirus (e.g. Coxsackie B virus serotypes [CVBs]) infections may be associated with development of type 1 diabetes. Studies conducted in several European countries have, however, shown an inverse correlation between the incidence of type 1 diabetes and the prevalence of enterovirus infections. These...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-013-2834-z
更新日期:2013-04-01 00:00:00
abstract:AIMS/HYPOTHESIS:In the UK, more than one million people have undiagnosed diabetes and an additional five million are at high risk of developing the disease. Given that early identification of these people is key for both primary and secondary prevention, new screening approaches are needed. Since spouses resemble each ...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-018-4587-1
更新日期:2018-07-01 00:00:00
abstract:AIMS/HYPOTHESIS:Evidence suggests that bacterial components in blood could play an early role in events leading to diabetes. To test this hypothesis, we studied the capacity of a broadly specific bacterial marker (16S rDNA) to predict the onset of diabetes and obesity in a general population. METHODS:Data from an Epid...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-011-2329-8
更新日期:2011-12-01 00:00:00
abstract::Human crude and recombinant interleukin 1 (IL-1) was found to dose- and time-dependently affect the biosynthesis of (pro)insulin in isolated rat islets of Langerhans. Incubation of rat islets with either 0.5 U/ml or 5 U/ml of crude IL-1 for 1 h had no detectable effect on (pro)insulin biosynthesis. After 24 hours of e...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00279615
更新日期:1987-07-01 00:00:00
abstract::The content of phosphoenolpyruvate (PEP) has been measured in isolated rat islets of Langerhans incubated in vitro. Islet PEP was higher in islets incubated with 16.7 mmol/1 glucose than in islets incubated with zero or 2.8 mmol/1 glucose. Islet PEP content was also increased in islet incubated with 5 mmol/1 D-glycera...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF01234500
更新日期:1977-09-01 00:00:00
abstract::Hypothalamic and autonomic nervous regulation of carbohydrate and amino acid metabolism in the liver and of lipid metabolism in adipose tissues is described. The direct neural mechanism underlying this regulation has been evaluated. Electrical stimulation of the ventromedial hypothalamic nucleus (VMH)-splanchnic nerve...
journal_title:Diabetologia
pub_type: 杂志文章,评审
doi:
更新日期:1981-03-01 00:00:00
abstract:AIMS/HYPOTHESIS:Somatostatin from islet delta cells inhibits insulin and glucagon secretion, but knowledge of the regulation of pancreatic somatostatin release is limited. Some insulin secretagogues stimulate somatostatin secretion, and here we investigated whether delta cell secretory responses are indirectly regulate...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-012-2546-9
更新日期:2012-07-01 00:00:00
abstract:AIMS/HYPOTHESIS:Cardiovascular disease (CVD) is the most common cause of premature death and disability among patients with type 1 diabetes. Diabetic nephropathy accounts for the increased cardiovascular morbidity and mortality of these patients. We recently showed that the intensity of exercise predicts the incidence ...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-016-4189-8
更新日期:2017-03-01 00:00:00
abstract::The spontaneous hypertensive rat is an animal model characterized by a syndrome of hypertension, insulin resistance and hyperinsulinaemia. To elucidate whether in analogy to other insulin resistant animal models an inactivity of the insulin receptor kinase or an alteration of the glucose transporter (GLUT 4) level in ...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00429089
更新日期:1992-08-01 00:00:00
abstract:AIMS/HYPOTHESIS:Rosiglitazone, an insulin sensitiser, not only improves insulin sensitivity but also enhances insulin secretory capacity by ameliorating gluco- and lipotoxicity in beta cells. Rosiglitazone can stimulate insulin secretion at basal and high glucose levels via a phosphatidylinositol 3-kinase (PI3K)-depend...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-009-1337-4
更新日期:2009-06-01 00:00:00
abstract::We have studied the epidemiologic characteristics of insulin-dependent (Type 1) diabetic patients aged 0-19 in a city (San Diego, southern California, USA) characterized by an impressive racial diversity and especially mild and constant climatic conditions. Ascertainment was through retrospective review of medical rec...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00265020
更新日期:1985-10-01 00:00:00
abstract::Epidemiologic data suggest that having a parent with Type 2 (non-insulin-dependent) diabetes mellitus increases the risk for Type 1 (insulin-dependent) diabetes in siblings of a Type 1 diabetes proband. This increase in risk is consistent with a shared genetic susceptibility between Type 1 diabetes and Type 2 diabetes...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00405008
更新日期:1991-05-01 00:00:00
abstract:AIMS/HYPOTHESIS:The aim of this study was to compare glycaemic control and maternal-fetal outcomes in women with type 1 diabetes managed on insulin pumps compared with multiple daily injections of insulin (MDI). METHODS:In a retrospective study, glycaemic control and outcomes of 387 consecutive pregnancies in women wi...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-014-3163-6
更新日期:2014-04-01 00:00:00
abstract::Type 1 diabetes is an immune-mediated disease leading to almost total beta cell destruction and permanent exogenous insulin dependency. The appearance of clinical symptoms is preceded by an asymptomatic preclinical period, the duration of which is highly individual. The emergence of diabetes-associated autoantibodies ...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-016-4147-5
更新日期:2017-01-01 00:00:00
abstract:AIMS/HYPOTHESIS:Insulin control of glucose output is a major mechanism by which appropriate amounts of glucose are produced to supply energy to the central nervous system, without causing long-term increases of the plasma glucose concentration. It is hypothesised that the primary route by which insulin maintains contro...
journal_title:Diabetologia
pub_type: 杂志文章,评审
doi:10.1007/s001250051474
更新日期:2000-07-01 00:00:00
abstract:AIMS/HYPOTHESIS:The aims of this work were to assess glycaemic control in metformin users receiving their first add-on glucose-lowering therapy and to examine the real-life effectiveness of different add-on drugs. METHODS:We carried out a population-based cohort study using healthcare databases in northern Denmark dur...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-015-3698-1
更新日期:2015-10-01 00:00:00
abstract:AIMS/HYPOTHESIS:Decreased sensing of the innate immune system may lead to chronic activation of the inflammatory cascade. We hypothesised that mannan-binding lectin (MBL) deficiency may confer risk of obesity and insulin resistance. MATERIALS AND METHODS:We performed a cross-sectional study of MBL protein concentratio...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/s00125-006-0381-6
更新日期:2006-10-01 00:00:00
abstract::Potassium homeostasis during a 50-g oral glucose tolerance test was studied in 14 newly diagnosed, untreated Type 2 (non-insulin-dependent) diabetics. They showed a rise in plasma potassium from a mean +/- SEM basal of 3.9 +/- 0.1 to 4.4 +/- 0.1 mmol/l at 60 min and to 4.6 +/- 0.1 mmol/l at 90 min (p less than 0.01), ...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00283750
更新日期:1982-03-01 00:00:00
abstract::The immune response of diabetic patients to influenza vaccination was examined in 31 patients, 10 with Type 1 (insulin-dependent) diabetes and 21 with Type 2 (non-insulin-dependent diabetes), and in 19 normal subjects. Each received a single intramuscular injection of the 3 virus strains (A/Chile,A/Philippines,B/USSR)...
journal_title:Diabetologia
pub_type: 杂志文章
doi:10.1007/BF00870139
更新日期:1986-12-01 00:00:00