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Trial record 41 of 226 for:    warfarin AND International

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

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ClinicalTrials.gov Identifier: NCT01432938
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Biological: dulaglutide
Drug: Warfarin
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Warfarin First, Then Dulaglutide + Warfarin Dulaglutide + Warfarin First, Then Warfarin
Hide Arm/Group Description

First Intervention: A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 (Treatment 1).

There was a washout period of at least 24 days between treatment periods.

Second Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2).

First Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2).

There was a washout period of at least 24 days between intervention periods.

Second Intervention: A single, 10-mg dose of warfarin administered orally on Day 1 (Treatment 1).

Period Title: First Intervention
Started 14 14
Received at Least 1 Dose of Study Drug 14 14
Completed 12 14
Not Completed 2 0
Reason Not Completed
Protocol Violation             1             0
Physician Decision             1             0
Period Title: Washout Period of at Least 24 Days
Started 12 14
Completed 12 14
Not Completed 0 0
Period Title: Second Intervention
Started 12 14
Completed 11 14
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Participants who received at least one dose of study drug (dulaglutide or warfarin).
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
Participants who received at least 1 dose of study drug (dulaglutide or warfarin).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
44.2  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
4
  14.3%
Male
24
  85.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
7
  25.0%
Not Hispanic or Latino
21
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
13
  46.4%
White
15
  53.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of R-warfarin and S-warfarin
Hide Description Area under the concentration versus time curve (AUC) from zero to infinity was determined from plasma concentrations of the S- and R- enantiomers of warfarin.
Time Frame Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of warfarin with evaluable warfarin concentration data.
Arm/Group Title Warfarin Alone Dulaglutide + Warfarin
Hide Arm/Group Description:
A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
Overall Number of Participants Analyzed 28 25
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms times hours per milliliter
S-warfarin
19200
(24%)
18900
(22%)
R-warfarin
33000
(25%)
32900
(24%)
2.Primary Outcome
Title Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of R-warfarin and S-warfarin
Hide Description [Not Specified]
Time Frame Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of warfarin with evaluable warfarin concentration data.
Arm/Group Title Warfarin Alone Dulaglutide + Warfarin
Hide Arm/Group Description:
A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
Overall Number of Participants Analyzed 28 25
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
S-warfarin
530
(19%)
414
(23%)
R-warfarin
530
(18%)
451
(19%)
3.Primary Outcome
Title Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-warfarin and S-warfarin
Hide Description [Not Specified]
Time Frame Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of warfarin with evaluable warfarin concentration data.
Arm/Group Title Warfarin Alone Dulaglutide + Warfarin
Hide Arm/Group Description:
A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
Overall Number of Participants Analyzed 28 25
Median (Full Range)
Unit of Measure: hours
S-warfarin
2.00
(1.00 to 4.00)
4.00
(1.00 to 24.02)
R-warfarin
2.00
(1.00 to 4.00)
8.00
(2.00 to 24.02)
4.Secondary Outcome
Title Pharmacodynamics: Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin
Hide Description AUCINR was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.
Time Frame Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of warfarin with evaluable warfarin INR data.
Arm/Group Title Warfarin Alone Dulaglutide + Warfarin
Hide Arm/Group Description:
A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
Overall Number of Participants Analyzed 28 25
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
157
(5%)
161
(5%)
5.Secondary Outcome
Title Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax) of Warfarin
Hide Description Observed INRmax was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.
Time Frame Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of warfarin with evaluable warfarin INR data.
Arm/Group Title Warfarin Alone Dulaglutide + Warfarin
Hide Arm/Group Description:
A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
Overall Number of Participants Analyzed 28 25
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
1.24
(13%)
1.27
(15%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Warfarin Alone Dulaglutide Alone Dulaglutide + Warfarin
Hide Arm/Group Description

A single, 10-milligram (mg) dose administered orally on Day 1 of Treatment 1.

Timeframe: Treatment 1

A single, 1.5-mg dose administered subcutaneously on Day 1 of Treatment 2.

Timeframe: Day 1 to Day 3 before dosing of warfarin in Treatment 2

A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2

Timeframe: After dosing of warfarin on Day 3 of Treatment 2

All-Cause Mortality
Warfarin Alone Dulaglutide Alone Dulaglutide + Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Warfarin Alone Dulaglutide Alone Dulaglutide + Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/26 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Warfarin Alone Dulaglutide Alone Dulaglutide + Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/28 (10.71%)      5/26 (19.23%)      4/25 (16.00%)    
Eye disorders       
Vision blurred  1  0/28 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/28 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0
Diarrhoea  1  1/28 (3.57%)  1 0/26 (0.00%)  0 2/25 (8.00%)  2
Gastrooesophageal reflux disease  1  0/28 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0
Haemorrhoids  1  0/28 (0.00%)  0 0/26 (0.00%)  0 1/25 (4.00%)  1
Lip dry  1  1/28 (3.57%)  1 0/26 (0.00%)  0 0/25 (0.00%)  0
Nausea  1  0/28 (0.00%)  0 2/26 (7.69%)  2 1/25 (4.00%)  1
Vomiting  1  0/28 (0.00%)  0 3/26 (11.54%)  3 0/25 (0.00%)  0
General disorders       
Fatigue  1  0/28 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0
Injection site pain  1  0/28 (0.00%)  0 0/26 (0.00%)  0 1/25 (4.00%)  1
Infections and infestations       
Upper respiratory tract infection  1  1/28 (3.57%)  1 0/26 (0.00%)  0 0/25 (0.00%)  0
Injury, poisoning and procedural complications       
Procedural dizziness  1  1/28 (3.57%)  2 0/26 (0.00%)  0 0/25 (0.00%)  0
Investigations       
Lipase increased  1  0/28 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  0/28 (0.00%)  0 2/26 (7.69%)  2 0/25 (0.00%)  0
Nervous system disorders       
Headache  1  0/28 (0.00%)  0 2/26 (7.69%)  2 0/25 (0.00%)  0
Paraesthesia  1  0/28 (0.00%)  0 1/26 (3.85%)  3 0/25 (0.00%)  0
Somnolence  1  1/28 (3.57%)  1 1/26 (3.85%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01432938     History of Changes
Other Study ID Numbers: 11549
H9X-MC-GBCS ( Other Identifier: Eli Lilly and Company )
First Submitted: September 9, 2011
First Posted: September 13, 2011
Results First Submitted: October 3, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014