Trial reportEndocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
Colesevelam hydrochloride added to background metformin therapy in patients with type 2 diabetes mellitus: a pooled analysis from 3 clinical studies.
Trial report in Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. The graph read 2 numbers from its abstract, feeding 2 cells of the map: it favours the comparator in 2. Cited by 4 papers.
What it found
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In comparison with placebo, colesevelam HCl significantly increased apo A-I (mean treatment difference: +3.3%; P<.0001), whereas the mean increase in HDL-C with colesevelam HCl was not significant.
Median triglyceride levels were increased with colesevelam HCl (median treatment difference: +12.8%; P<.0001).
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Other glucose-lowering×lipids
ContradictsOpen on the map →What to test next →3 readable studies in this cell: 0 favour the treatment, 2 find no difference, 1 favour the comparator.
Other lipid agents×lipids
ContradictsOpen on the map →What to test next →28 readable studies in this cell: 17 favour the treatment, 2 find no difference, 9 favour the comparator.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 24 citations in OpenAlex.
- Bile acids and microbes in metabolic disease.World journal of gastroenterology · 2022Review
- Targeting the Enteroendocrine System for Treatment of Obesity.Handbook of experimental pharmacology · 2022Article
- Modulation of Bile Acid Metabolism to Improve Plasma Lipid and Lipoprotein Profiles.Journal of clinical medicine · 2021Review
- Bile acid receptors as targets for the treatment of dyslipidemia and cardiovascular disease.Journal of lipid research · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The marked sentences are the ones the graph read a number from.
objectiveTo evaluate the glucose- and lipid-altering efficacy of colesevelam hydrochloride (HCl) when added to background metformin therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM).
methodsThis post hoc analysis included patients with T2DM from 3 randomized, double-blind, placebo-controlled pivotal studies who received metformin as part of their background antidiabetes therapy. In the pivotal studies, patients with T2DM were randomly assigned to receive colesevelam HCl (3.75 g/d) or placebo added to existing metformin (26 weeks), sulfonylurea (26 weeks), or insulin (16 weeks) monotherapy or combination therapy, wherein the combination therapies may have included metformin.
resultsIn this pooled analysis of 696 patients with T2DM who were receiving metformin monotherapy or metformin combined with other antidiabetes therapies, 355 were randomly assigned to receive colesevelam HCl and 341 to receive placebo. In comparison with placebo, colesevelam HCl significantly reduced hemoglobin A1c (A1C) and fasting plasma glucose (mean treatment difference: -0.50% and -15.7 mg/dL, respectively; P<.001 for both), as well as significantly reduced levels of low-density lipoprotein cholesterol (LDL-C; mean treatment difference: -16.5%), total cholesterol (TC; -5.8%), non-high-density lipoprotein cholesterol (non-HDL-C; -8.2%), and apolipoprotein (apo) B (-7.6%) (P<.0001 for all). Median triglyceride levels were increased with colesevelam HCl (median treatment difference: +12.8%; P<.0001). In comparison with placebo, colesevelam HCl significantly increased apo A-I (mean treatment difference: +3.3%; P<.0001), whereas the mean increase in HDL-C with colesevelam HCl was not significant. Colesevelam HCl therapy was generally well tolerated.
conclusionWhen added to metformin-including therapy, colesevelam HCl significantly reduced A1C and fasting glucose, as well as levels of LDL-C, TC, non-HDL-C, and apo B in patients with inadequately controlled T2DM.
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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.