ArticleBMC neurology2018
Rationale and design of the CAROLINA® - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus.
Article in BMC neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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.
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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.
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Who cites it
13 citing papers in PubMed, 31 citations in OpenAlex.
- Effects of linagliptin vs glimepiride on cognitive performance in type 2 diabetes: results of the randomised double-blind, active-controlled CAROLINA-COGNITION study.Diabetologia · 2021Trial
- Occurrence of mild cognitive impairment with hyperinsulinaemia in Africans with advanced type 2 diabetes mellitus.IBRO neuroscience reports · 2022Article
- Clinical efficacy of nutritional diet therapy on gestational diabetes mellitus.American journal of translational research · 2022Article
- Metforminium Decavanadate (MetfDeca) Treatment Ameliorates Hippocampal Neurodegeneration and Recognition Memory in a Metabolic Syndrome Model.Neurochemical research · 2021Article
- Diabetes, Brain Infarcts, Cognition, and Small Vessels in the Canadian Alliance for Healthy Hearts and Minds Study.The Journal of clinical endocrinology and metabolism · 2021Article
- Diabetes Therapies for Dementia.Current neurology and neuroscience reports · 2019Review
- Safety and efficacy of antihyperglycaemic agents in diabetic kidney disease.Endocrinology, diabetes & metabolism · 2019Review
- Antidiabetic treatment on memory and spatial learning: From the pancreas to the neuron.World journal of diabetes · 2019Review
- Dipeptidyl Peptidase-4 Inhibitors for the Potential Treatment of Brain Disorders; A Mini-Review With Special Focus on Linagliptin and Stroke.Frontiers in neurology · 2019Review
- HbADiabetes care · 2019Article
- Risk of Dementia in Older Patients with Type 2 Diabetes on Dipeptidyl-Peptidase IV Inhibitors Versus Sulfonylureas: A Real-World Population-Based Cohort Study.Journal of clinical medicine · 2018Article
- Pre-diabetes and diabetes are independently associated with adverse cognitive test results: a cross-sectional, population-based study.BMC endocrine disorders · 2018Observational
- A Review on Cardiovascular Outcome Studies of Dipeptidyl Peptidase-4 Inhibitors.Indian journal of endocrinology and metabolismReview
Corrections and comments
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Authors and funding
8 authors at 5 institutions in 5 countries.
Funding
Abstract
backgroundType 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond glucose lowering. This paper presents the design of a study that aims to establish if linagliptin is superior to the sulfonylurea glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus.
methodsThe cognition substudy is an integral part of the ongoing event-driven, randomised, double blind CARdiOvascular safety of LINAgliptin (CAROLINA®) trial, which evaluates the effect of treatment with linagliptin versus glimepiride on cardiovascular outcomes. CAROLINA® includes patients with type 2 diabetes mellitus with sub-optimal glycaemic control at elevated cardiovascular risk. The substudy will evaluate patients randomised and treated who have a baseline Mini Mental State Examination (MMSE) score ≥ 24, documented years of formal education with at least one valid cognitive assessment at baseline and during follow-up. The primary cognitive outcome is the occurrence of accelerated cognitive decline at the end of follow-up. The two treatment groups will be compared by using a logistic regression. Accelerated cognitive decline is defined as a rate of cognitive decline that falls at or below the 16th percentile of decline for the whole cohort on either the MMSE or a combined score of the trail making and verbal fluency test. Potential confounders are taken into account at an individual patient level, using a regression based index. DISCUSSION: Between December 2010 and December 2012, 6042 patients were randomised and treated with either linagliptin (5 mg) or glimepiride (1-4 mg) once daily in CAROLINA®. Cognitive tests were conducted in nearly 4500 participants at baseline and are scheduled for two subsequent assessments, after 160 weeks of follow-up and end of follow-up. This substudy of the ongoing CAROLINA® trial will establish if linagliptin is superior to glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus. Final results are expected in 2019.
trial registrationClinicalTrials.gov Identifier: NCT 01243424 .
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