Evidence mapPaperPMID 18458145Full record

Trial reportDiabetes care2008

Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy.

Vivian A Fonseca, Julio Rosenstock, Antonia C Wang, Kenneth E Truitt, Michael R Jones

3 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 81 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 1 pooled it
17.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT00938405 nacompletednot on this mapstarted 2009, after this paper: background citation

Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus

TypeinterventionalSponsorUniversity of Colorado, DenverRan2009 to 2009Enrolled45ConditionsDiabetes Mellitus, Type 1, HyperlipidemiasArmsColesevelam HCl, Placebo
NCT01092663 nacompletednot on this mapstarted 2010, after this paper: background citation

The Effects of Co-administration of Colesevelam and Sitagliptin on Glucose Metabolism in Patients With Type 2 Diabetes

TypeinterventionalSponsorKineMedRan2010 to 2011Enrolled61ConditionsDiabetes Mellitus, Type 2ArmsColesevelam HCl, Sitagliptin
NCT02504736 completednot on this mapstarted 2015, after this paper: background citation

24 Week Open Label, Single Arm Study of Colesevelam in High Risk South Asians With Suboptimal LDL-c Levels Despite Maximally Tolerated Statin Therapy

TypeobservationalSponsorCanadian Collaborative Research NetworkRan2015 to 2018Enrolled90ConditionsDyslipidemia
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 1 synthesis or guideline pooled it, 246 citations in OpenAlex.

  1. Colesevelam for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2012
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Bile acids and microbes in metabolic disease.World journal of gastroenterology · 2022
    Review
  14. Type 2 Diabetes and the Microbiome.Journal of the Endocrine Society · 2022
    Review
  15. Review
  16. Review
  17. Metabolic Effects of Bile Acids: Potential Role in Bariatric Surgery.Cellular and molecular gastroenterology and hepatology · 2019
    Review
  18. Intestinal bile acid sequestration improves glucose control by stimulating hepatic miR-182-5p in type 2 diabetes.American journal of physiology. Gastrointestinal and liver physiology · 2018
    Article
  19. Bile acid signaling and bariatric surgery.Liver research (Beijing, China) · 2017
    Article
  20. Review

21 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Vivian A FonsecaTulane University Health Sciences Center, New Orleans, Louisiana, USA. vfonseca@tulane.edu
Julio Rosenstock
Antonia C Wang
Kenneth E Truitt
Michael R Jones
Daiichi Sankyo (United States) · USDallas Diabetes Research Center · USTulane University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveHyperglycemia is a risk factor for microvascular complications and may increase the risk of cardiovascular disease in patients with type 2 diabetes. This study tested the LDL cholesterol-lowering agent colesevelam HCl (colesevelam) as a potential novel treatment for improving glycemic control in patients with type 2 diabetes on sulfonylurea-based therapy. RESEARCH DESIGN AND

methodsA 26-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study was carried out between August 2004 and August 2006 to evaluate the efficacy and safety of colesevelam for reducing A1C in adults with type 2 diabetes whose glycemic control was inadequate (A1C 7.5-9.5%) with existing sulfonylurea monotherapy or sulfonylurea in combination with additional oral antidiabetes agents. In total, 461 patients were randomized (230 given colesevelam 3.75 g/day and 231 given placebo). The primary efficacy measurement was mean placebo-corrected change in A1C from baseline to week 26 in the intent-to-treat population (last observation carried forward).

resultsThe least squares (LS) mean change in A1C from baseline to week 26 was -0.32% in the colesevelam group and +0.23% in the placebo group, resulting in a treatment difference of -0.54% (P < 0.001). The LS mean percent change in LDL cholesterol from baseline to week 26 was -16.1% in the colesevelam group and +0.6% in the placebo group, resulting in a treatment difference of -16.7% (P < 0.001). Furthermore, significant reductions in fasting plasma glucose, fructosamine, total cholesterol, non-HDL cholesterol, and apolipoprotein B were demonstrated in the colesevelam relative to placebo group at week 26.

conclusionsColesevelam improved glycemic control and reduced LDL cholesterol levels in patients with type 2 diabetes receiving sulfonylurea-based therapy.

Indexed as

AdultAgedAllylamineAnticholesteremic AgentsBlood GlucoseBody Mass IndexCholesterol, LDLColesevelam HydrochlorideDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemic AgentsMaleAllylamineAnticholesteremic AgentsBlood GlucoseCholesterol, LDLColesevelam HydrochlorideGlycated HemoglobinHypoglycemic AgentsPlacebosSulfonylurea Compounds

Identifiers

PMID18458145
PMCPMC2494667
OpenAlexW2046189497

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.