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Trial record 37 of 39 for:    LY2189265

A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe

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ClinicalTrials.gov Identifier: NCT01524770
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : October 22, 2014
Last Update Posted : October 22, 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
Intervention Biological: Dulaglutide
Enrollment 50

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Manual Syringe First, Then Auto-injector Auto-injector First, Then Manual Syringe
Hide Arm/Group Description

First Intervention:

Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.

There was a washout period of at least 28 days between treatment periods.

Second intervention:

Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector.

First Intervention:

Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.

There was a washout period of at least 28 days between treatment periods.

Second intervention:

Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe.

Period Title: First Intervention
Started 26 24
Received at Least 1 Dose of Study Drug 26 24
Completed 23 23
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             1             1
Protocol Violation             1             0
Period Title: Washout Period of at Least 28 Days
Started 23 23
Completed 23 23
Not Completed 0 0
Period Title: Second Intervention
Started 23 23
Completed 23 23
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
Participants who received at least 1 dose of dulaglutide.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
42.3  (17.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
10
  20.0%
Male
40
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
14
  28.0%
Not Hispanic or Latino
36
  72.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 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
12
  24.0%
White
35
  70.0%
More than one race
3
   6.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide
Hide Description [Not Specified]
Time Frame Predose to 336 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.
Arm/Group Title Auto-injector Manual Syringe
Hide Arm/Group Description:
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
Overall Number of Participants Analyzed 47 47
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms times hours per milliliters
14700
(22%)
14300
(24%)
2.Primary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide
Hide Description [Not Specified]
Time Frame Predose to 336 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.
Arm/Group Title Auto-injector Manual Syringe
Hide Arm/Group Description:
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
Overall Number of Participants Analyzed 47 48
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
91.1
(31%)
88.2
(32%)
3.Secondary Outcome
Title Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide
Hide Description [Not Specified]
Time Frame Predose to 336 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of dulaglutide with evaluable concentration-time data.
Arm/Group Title Auto-injector Manual Syringe
Hide Arm/Group Description:
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
Overall Number of Participants Analyzed 47 48
Median (Full Range)
Unit of Measure: hours
48.0
(24.0 to 96.0)
48.0
(24.0 to 96.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Auto-injector Manual Syringe
Hide Arm/Group Description Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
All-Cause Mortality
Auto-injector Manual Syringe
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Auto-injector Manual Syringe
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/47 (0.00%)      0/49 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Auto-injector Manual Syringe
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/47 (38.30%)      18/49 (36.73%)    
Gastrointestinal disorders     
Constipation  1  5/47 (10.64%)  6 2/49 (4.08%)  2
Diarrhoea  1  0/47 (0.00%)  0 3/49 (6.12%)  3
Nausea  1  4/47 (8.51%)  4 6/49 (12.24%)  6
Vomiting  1  1/47 (2.13%)  1 3/49 (6.12%)  4
General disorders     
Asthenia  1  0/47 (0.00%)  0 3/49 (6.12%)  3
Metabolism and nutrition disorders     
Decreased appetite  1  6/47 (12.77%)  6 8/49 (16.33%)  8
Nervous system disorders     
Headache  1  5/47 (10.64%)  5 5/49 (10.20%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01524770     History of Changes
Other Study ID Numbers: 14142
H9X-MC-GBDT ( Other Identifier: Eli Lilly and Company )
First Submitted: January 31, 2012
First Posted: February 2, 2012
Results First Submitted: October 3, 2014
Results First Posted: October 22, 2014
Last Update Posted: October 22, 2014