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Trial · NCT02058641

Effect of Darapladib on Cantharidin-Induced Inflammatory Blisters in Subjects With Type 2 Diabetes Mellitus (T2DM)

NCT02058641, Phase 1, Completed, GlaxoSmithKline

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Effect of Darapladib on Cantharidin-Induced Inflammatory Blisters in Subjects With Type 2 Diabetes Mellitus (T2DM). Trials, record NCT02058641. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02058641

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effect of Darapladib on Cantharidin-Induced Inflammatory Blisters in Subjects With Type 2 Diabetes Mellitus (T2DM)
NCT number
NCT02058641
Status
Completed
Phases
Phase 1
Enrollment
9 participants, actual
Lead sponsor
GlaxoSmithKline
Conditions
Atherosclerosis
Interventions
Darapladib
First posted
2014-02-10
Last updated
2017-05-15

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMacrophage cell count and surface expression of markers of M1 and M2 polarization in blister fluidUp to 6 weeks
To assess the effect of an 11 day course of once daily darapladib EC 160 mg on the number and phenotype (M1/M2 polarization) of macrophages isolated from blisters on subjects with type 2 diabetes mellitus (blisters induced by exposure to cantharidin for 48 hours). Biomarkers may include, but not be limited to: Cluster of differentiation (CD)11b, CD14, CD16, CD33, CD40, CD64, CD68, CD86, CD163, CD206, C-C chemokine receptor type 2 (CCR2), CX3 chemokine receptor 1 (CX3CR1)
SecondaryNumber of monocytes and surface expression of markers of M1 or M2 polarization in peripheral bloodUp to 6 weeks
To assess the effect of an 11 day course of once daily darapladib EC 160 mg on the number and phenotype of monocytes (M1/M2 ratio) isolated from peripheral blood of subjects with type 2 diabetes mellitus. Biomarkers may include, but not be limited to: CD11b, CD14, CD16, CD40, CD64, CD68, CD163, CD206
SecondaryEnzymatic activity of Lp-PLA2 in blister fluidUp to 6 weeksBlood samples will be taken for assessments of enzymatic activity of Lp-PLA2 (measured by hydrolysis of radio-labeled platelet-activating factor \[PAF\])
SecondaryTotal cell count, lymphocyte count, neutrophil count and macrophage count in blister fluidUp to 6 weeksBlister fluids will be collected to assess the differences in blister phenotype (volume, appearance, cellularity) between subjects
SecondaryConcentrations of soluble mediators of macrophage polarizationUp to 6 weeks
Soluble mediators will be measured in blister fluid assessed by a multiplex platform (Meso scale delivery or Luminex) and may include but not be restricted to matrix metalloproteinase 9 (MMP9), interleukin (IL)-12, IL-23, IL-10, interferon-gamma, tumor necrosis factor-alpha, IL-1 beta, IL-6, IL-8, IL-4, IL-13, transforming growth factor-beta, monocyte chemotactic protein-1 and C-reactive protein
SecondaryTime to healing of cantharidin-induced blistersUp to 8 weeksBlisters will be considered to be healed when the blister cover has fallen off and the blister area becomes dry

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02058641

GET https://conductscience.org/api/trials/v1/NCT02058641/registered