Trial reportDiabetic medicine : a journal of the British Diabetic Association2007
Rosiglitazone RECORD study: glucose control outcomes at 18 months.
Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00379769. Cited by 24 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia
Open the trial in the graphWho cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- Metformin and second- or third-generation sulphonylurea combination therapy for adults with type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2019 · on this mapPooled it
- Second-line therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a systematic review and mixed-treatment comparison meta-analysis.Open medicine : a peer-reviewed, independent, open-access journal · 2011Pooled it
- Trial
- Efficacy and safety of traditional chinese medicine for diabetes: a double-blind, randomised, controlled trial.PloS one · 2013Trial
- Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial.European heart journal · 2010Trial
- Efficacy and Safety of DPP-4 Inhibitors and Metformin Combinations in Type 2 Diabetes: A Systematic Literature Review and Network Meta-Analysis.Diabetes, metabolic syndrome and obesity : targets and therapy · 2024Article
- The forgotten type 2 diabetes mellitus medicine: rosiglitazone.Diabetology international · 2022Review
- Fracture risk in type 2 diabetic patients: A clinical prediction tool based on a large population-based cohort.PloS one · 2018Article
- The Infamous, Famous Sulfonylureas and Cardiovascular Safety: Much Ado About Nothing?Current diabetes reports · 2017Review
- Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks.Diabetes & metabolism journal · 2017Article
- Okara ameliorates glucose tolerance in GK rats.Journal of clinical biochemistry and nutrition · 2016Article
- Incident type 2 diabetes and hip fracture risk: a population-based matched cohort study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015Article
- Assessment of pancreatic β-cell function: review of methods and clinical applications.Current diabetes reviews · 2014Review
- Pathophysiologic approach to therapy in patients with newly diagnosed type 2 diabetes.Diabetes care · 2013 · on this mapArticle
- Rosiglitazone: a European regulatory perspective.Diabetologia · 2011Article
- Triple Combination Therapy Using Metformin, Thiazolidinedione, and a GLP-1 Analog or DPP-IV Inhibitor in Patients with Type 2 Diabetes Mellitus.Korean diabetes journal · 2010Article
- Pioglitazone and alogliptin combination therapy in type 2 diabetes: a pathophysiologically sound treatment.Vascular health and risk management · 2010Review
- Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes.Health and quality of life outcomes · 2009Article
- Is the evidence from clinical trials for cardiovascular risk or harm for glitazones convincing?Current diabetes reports · 2009Review
- Efficacy of peroxisome proliferator-activated receptor agonists in diabetes and coronary artery disease.Current atherosclerosis reports · 2009Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo compare glucose control over 18 months between rosiglitazone oral combination therapy and combination metformin and sulphonylurea in people with Type 2 diabetes.
methodsRECORD, a multicentre, parallel-group study of cardiovascular outcomes, enrolled people with an HbA(1c) of 7.1-9.0% on maximum doses of metformin or sulphonylurea. If on metformin they were randomized to add-on rosiglitazone or sulphonylurea (open label) and if on sulphonylurea to rosiglitazone or metformin. HbA(1c) was managed to < or = 7.0% by dose titration. A prospectively defined analysis of glycaemic control on the first 1122 participants is reported here, with a primary outcome assessed against a non-inferiority margin for HbA(1c) of 0.4%.
resultsAt 18 months, HbA(1c) reduction on background metformin was similar with rosiglitazone and sulphonylurea [difference 0.07 (95% CI -0.09, 0.23)%], as was the change when rosiglitazone or metformin was added to sulphonylurea [0.06 (-0.09, 0.20)%]. At 6 months, the effect on HbA(1c) was greater with add-on sulphonylurea, but was similar whether sulphonylurea was added to rosiglitazone or metformin. Differences in fasting plasma glucose were not statistically significant at 18 months [rosiglitazone vs. sulphonylurea -0.36 (-0.74, 0.02) mmol/l, rosiglitazone vs. metformin -0.34 (-0.73, 0.05) mmol/l]. Increased homeostasis model assessment insulin sensitivity and reduced C-reactive protein were greater with rosiglitazone than metformin or sulphonylurea (all P < or = 0.001). Body weight was significantly increased with rosiglitazone compared with sulphonylurea [difference 1.2 (0.4, 2.0) kg, P = 0.003] and metformin [difference 4.3 (3.6, 5.1) kg, P < 0.001].
conclusionsIn people with diabetes, rosiglitazone in combination with metformin or sulphonylurea was demonstrated to be non-inferior to the standard combination of metformin + sulphonylurea in lowering HbA(1c) over 18 months, and produces greater improvements in C-reactive protein and basal insulin sensitivity but is also associated with greater weight gain.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.