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Study · Non-randomized trial · 2017

11 results

No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide.

de la Peña A, de la Peña A, Cui X, Geiser J, Loghin C

Clinical pharmacokinetics1 Nov 2017Cited by 22 (Europe PMC)

PMID28357715 (opens in a new tab)DOI10.1007/s40262-017-0531-7 (opens in a new tab)PepBankPUB-28357715
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In healthy subjects, digoxin AUC was similar with and without dulaglutide.

    In plain wordsIn healthy people, digoxin exposure was similar with and without dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeDigoxin AUC
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Areas under the concentration-time curves (AUCs) with and without dulaglutide were similar for all analytes except atorvastatin, where it was reduced by 21%.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  2. 02HumanNon-randomized trialPharmacokinetics

    In healthy subjects, warfarin analyte AUCs were similar with and without dulaglutide.

    In plain wordsIn healthy people, exposure to warfarin analytes was similar with and without dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeWarfarin analyte AUCs
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Areas under the concentration-time curves (AUCs) with and without dulaglutide were similar for all analytes except atorvastatin, where it was reduced by 21%.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy subjects, oral contraceptive analyte AUCs were similar with and without dulaglutide.

    In plain wordsIn healthy people, exposure to contraceptive analytes was similar with and without dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeOral contraceptive analyte AUCs
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Areas under the concentration-time curves (AUCs) with and without dulaglutide were similar for all analytes except atorvastatin, where it was reduced by 21%.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  4. 04HumanNon-randomized trialPharmacokinetics

    In healthy subjects, dulaglutide reduced atorvastatin AUC by 21% versus no dulaglutide.

    In plain wordsIn healthy people, dulaglutide reduced atorvastatin exposure by 21% compared with no dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseAtorvastatin AUC
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Measurements

    Atorvastatin AUC reduction
    21%
    with versus without dulaglutide

    Source sentences

    Summary
    Areas under the concentration-time curves (AUCs) with and without dulaglutide were similar for all analytes except atorvastatin, where it was reduced by 21%.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  5. 05HumanNon-randomized trialPharmacokinetics

    In healthy subjects, dulaglutide significantly reduced digoxin maximum concentration versus no dulaglutide.

    In plain wordsIn healthy people, dulaglutide reduced the digoxin peak compared with no dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseDigoxin maximum concentration
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Maximum concentrations (C max) were generally lower following coadministration with dulaglutide, with statistically significant reductions (90% confidence intervals of geometric least squares means ratios outside 0.80-1.25) for all analytes except R-warfarin.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  6. 06HumanNon-randomized trialPharmacokinetics

    In healthy subjects, dulaglutide significantly reduced maximum concentrations for warfarin analytes except R-warfarin versus no dulaglutide.

    In plain wordsIn healthy people, dulaglutide lowered the peak level of most warfarin analytes compared with no dulaglutide, but the drop for R-warfarin was not significant.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    MixedWarfarin analyte maximum concentrations
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Maximum concentrations (C max) were generally lower following coadministration with dulaglutide, with statistically significant reductions (90% confidence intervals of geometric least squares means ratios outside 0.80-1.25) for all analytes except R-warfarin.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  7. 07HumanNon-randomized trialPharmacokinetics

    In healthy subjects, dulaglutide significantly reduced atorvastatin maximum concentration versus no dulaglutide.

    In plain wordsIn healthy people, dulaglutide reduced the atorvastatin peak compared with no dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseAtorvastatin maximum concentration
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Maximum concentrations (C max) were generally lower following coadministration with dulaglutide, with statistically significant reductions (90% confidence intervals of geometric least squares means ratios outside 0.80-1.25) for all analytes except R-warfarin.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  8. 08HumanNon-randomized trialPharmacokinetics

    In healthy subjects, dulaglutide significantly reduced oral contraceptive analyte maximum concentrations versus no dulaglutide.

    In plain wordsIn healthy people, dulaglutide reduced contraceptive analyte peaks compared with no dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseOral contraceptive analyte maximum concentrations
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Maximum concentrations (C max) were generally lower following coadministration with dulaglutide, with statistically significant reductions (90% confidence intervals of geometric least squares means ratios outside 0.80-1.25) for all analytes except R-warfarin.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  9. 09HumanNon-randomized trialPharmacokinetics

    In healthy subjects, all analytes showed a general trend toward longer time to maximum concentration with dulaglutide versus no dulaglutide.

    In plain wordsIn healthy people, tested drugs generally reached peak concentrations later with dulaglutide than without it.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseTime to maximum concentration across analytes
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    For all analytes, there was a general trend for the time to C max (t max) to increase following coadministration with dulaglutide.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  10. 10HumanNon-randomized trialMechanism

    In healthy subjects receiving warfarin, dulaglutide did not significantly affect maximum INR versus no dulaglutide.

    In plain wordsIn healthy people receiving warfarin, maximum INR did not differ significantly with and without dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeMaximum INR
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Bleeding and clotting · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    For warfarin, dulaglutide coadministration had no statistically significant effect on the maximum INR (INRmax); however, a 2% increase in area under the INR curve (AUCINR) was observed.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.
  11. 11HumanNon-randomized trialMechanism

    In healthy subjects receiving warfarin, dulaglutide increased area under the INR curve by 2% versus no dulaglutide.

    In plain wordsIn healthy people receiving warfarin, dulaglutide increased overall INR exposure by 2% compared with no dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseArea under INR curve
    Study

    n: not reported in source

    Comparator
    Without dulaglutide
    Outcome group
    Bleeding and clotting · Pharmacology
    Studied dose
    1.5 mg · subcutaneousAs given in this study (human).

    Measurements

    AUC of INR increase
    2%
    warfarin with versus without dulaglutide

    Source sentences

    Summary
    For warfarin, dulaglutide coadministration had no statistically significant effect on the maximum INR (INRmax); however, a 2% increase in area under the INR curve (AUCINR) was observed.
    1 context sentence
    Summary · context
    In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials5

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

5 trials · 5 completed · 4 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT05459285

A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

Sunshine Lake Pharma Co., Ltd.n = 6831 May 2022 to 8 Jul 2022

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 25 Aug 2022
CompletedPhase 1Results postedNCT01458210

A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants

Eli Lilly and Companyn = 22Oct 2011 to Feb 2012

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 8 Oct 2014
CompletedPhase 1Results postedNCT01432938

A Study of the Effect of Dulaglutide on the Action of Warfarin in Healthy Participants

Eli Lilly and Companyn = 28Sept 2011 to Dec 2011

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 7 Oct 2014
CompletedPhase 1Results postedNCT01436201

A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants

Eli Lilly and Companyn = 24Sept 2011 to Nov 2011

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 7 Oct 2014
CompletedPhase 1Results postedNCT01250834

LY2189265 and Atorvastatin Interaction Study

Eli Lilly and Companyn = 27Dec 2010 to Mar 2011

Healthy Volunteers

Trial pageClinicalTrials.govUpdated 8 Oct 2014

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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