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A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT01301092
Recruitment Status : Completed
First Posted : February 23, 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 II
Intervention Biological: LY2189265
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: LY2189265 Intravenous Part B: LY2189265 Subcutaneous, Intravenous Part C: LY2189265 Subcutaneous, Intramuscular
Hide Arm/Group Description Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265. Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods. Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
Period Title: Overall Study
Started 6 16 8
Completed 6 16 7
Not Completed 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             1
Arm/Group Title Part A: LY2189265 Intravenous Part B: LY2189265 Subcutaneous, Intravenous Part C: LY2189265 Subcutaneous, Intramuscular Total
Hide Arm/Group Description Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265 Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods Total of all reporting groups
Overall Number of Baseline Participants 6 16 8 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 16 participants 8 participants 30 participants
47.0  (13.1) 42.3  (15.0) 45.6  (16.6) 44.10  (14.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 16 participants 8 participants 30 participants
Female
3
  50.0%
4
  25.0%
3
  37.5%
10
  33.3%
Male
3
  50.0%
12
  75.0%
5
  62.5%
20
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 16 participants 8 participants 30 participants
Hispanic or Latino
1
  16.7%
0
   0.0%
0
   0.0%
1
   3.3%
Not Hispanic or Latino
5
  83.3%
16
 100.0%
8
 100.0%
29
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 16 participants 8 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  12.5%
3
  37.5%
5
  16.7%
White
6
 100.0%
14
  87.5%
5
  62.5%
25
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 16 participants 8 participants 30 participants
6 16 8 30
1.Primary Outcome
Title Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
Hide Description AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Time Frame Predose up to 336 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in Part B who had pharmacokinetic (PK) data.
Arm/Group Title Part B: LY2189265 Subcutaneous Part B: LY2189265 Intravenous
Hide Arm/Group Description:
Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
Overall Number of Participants Analyzed 16 16
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanograms*hour/milliliter/milligram
10256
(8964 to 11734)
23150
(20234 to 26485)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: LY2189265 Subcutaneous, Part B: LY2189265 Intravenous
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Linear effects model analyses
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Mean
Estimated Value 0.443
Confidence Interval (2-Sided) 90%
0.395 to 0.497
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
Hide Description The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Time Frame Predose up to 336 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in Part B who had pharmacokinetic (PK) data.
Arm/Group Title Part B: LY2189265 Subcutaneous Part B: LY2189265 Intravenous
Hide Arm/Group Description:
Single 1.5-milligram (mg) subcutaneous (SC) dose of LY2189265 in Period 1 or 2
Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
Overall Number of Participants Analyzed 16 16
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanograms/milliliter (ng/mL)
80.7
(71.8 to 90.8)
38.3
(34.1 to 43.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: LY2189265 Subcutaneous, Part B: LY2189265 Intravenous
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Linear effects model analyses
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Mean
Estimated Value 2.10
Confidence Interval (2-Sided) 90%
1.84 to 2.41
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
Hide Description AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Time Frame Predose up to 336 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in Part C who had pharmacokinetic (PK) data.
Arm/Group Title Part C: LY2189265 Intramuscular Part C: LY2189265 Subcutaneous
Hide Arm/Group Description:
Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1or 2
Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
Overall Number of Participants Analyzed 7 8
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
9828
(7525 to 12837)
10215
(7832 to 13323)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part C: LY2189265 Intramuscular, Part C: LY2189265 Subcutaneous
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Linear effects model analyses
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 0.962
Confidence Interval (2-Sided) 90%
0.858 to 1.08
Estimation Comments [Not Specified]
4.Secondary Outcome
Title )Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
Hide Description The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Time Frame Predose up to 336 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in Part C who had pharmacokinetic (PK) data.
Arm/Group Title Part C: LY2189265 Intramuscular Part C: LY2189265 Subcutaneous
Hide Arm/Group Description:
Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1 or 2
Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
Overall Number of Participants Analyzed 7 8
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanograms/milliliter (ng/mL)
56.9
(48.4 to 67.0)
54.2
(46.3 to 63.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part C: LY2189265 Intramuscular, Part C: LY2189265 Subcutaneous
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Linear effects model analyses
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.924 to 1.19
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: 0.1 mg IV LY2189265 Part B: 0.1 mg IV LY2189265 Part B: 1.5 mg SC LY2189265 Part C: 0.75 mg IM LY2189265 Part C: 0.75 mg SC LY2189265
Hide Arm/Group Description Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265 Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2. Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
All-Cause Mortality
Part A: 0.1 mg IV LY2189265 Part B: 0.1 mg IV LY2189265 Part B: 1.5 mg SC LY2189265 Part C: 0.75 mg IM LY2189265 Part C: 0.75 mg SC LY2189265
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part A: 0.1 mg IV LY2189265 Part B: 0.1 mg IV LY2189265 Part B: 1.5 mg SC LY2189265 Part C: 0.75 mg IM LY2189265 Part C: 0.75 mg SC LY2189265
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/16 (0.00%)      0/16 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: 0.1 mg IV LY2189265 Part B: 0.1 mg IV LY2189265 Part B: 1.5 mg SC LY2189265 Part C: 0.75 mg IM LY2189265 Part C: 0.75 mg SC LY2189265
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      7/16 (43.75%)      9/16 (56.25%)      3/8 (37.50%)      2/8 (25.00%)    
Gastrointestinal disorders           
Abdominal pain  1  0/6 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Dyspepsia  1  0/6 (0.00%)  0 0/16 (0.00%)  0 3/16 (18.75%)  3 0/8 (0.00%)  0 2/8 (25.00%)  2
Gastrooesophageal reflux disease  1  0/6 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Nausea  1  0/6 (0.00%)  0 1/16 (6.25%)  1 2/16 (12.50%)  2 0/8 (0.00%)  0 1/8 (12.50%)  1
Toothache  1  0/6 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Vomiting  1  0/6 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 1/8 (12.50%)  1 1/8 (12.50%)  1
General disorders           
Application site erythema  1  0/6 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Extravasation  1  0/6 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Oedema  1  0/6 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Vessel puncture site haematoma  1  0/6 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations           
Candidiasis  1  0/6 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Injury, poisoning and procedural complications           
Procedural site reaction  1  0/6 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Metabolism and nutrition disorders           
Decreased appetite  1  0/6 (0.00%)  0 0/16 (0.00%)  0 3/16 (18.75%)  3 0/8 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/6 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Muscle spasms  1  0/6 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Nervous system disorders           
Dizziness  1  0/6 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Dysaesthesia  1  0/6 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Headache  1  0/6 (0.00%)  0 2/16 (12.50%)  2 6/16 (37.50%)  7 1/8 (12.50%)  1 0/8 (0.00%)  0
Reproductive system and breast disorders           
Dysmenorrhoea  1  0/6 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain  1  0/6 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders           
Dermatitis  1  0/6 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Dermatitis contact  1  0/6 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: NCT01301092     History of Changes
Other Study ID Numbers: 13989
H9X-MC-GBDR ( Other Identifier: Eli Lilly and Company )
First Submitted: February 18, 2011
First Posted: February 23, 2011
Results First Submitted: October 3, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014