Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Multiple Doses of LY2922470 in Participants With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867216
Recruitment Status : Completed
First Posted : June 3, 2013
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Diabetes Mellitus, Type 2
Interventions Drug: Placebo
Drug: LY2922470
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description Placebo administered orally once daily (QD) or twice daily (BID) for up to 28 days. 60 mg LY2922470 administered orally QD for up to 28 days. 200 mg LY2922470 administered orally QD for up to 28 days. 500 mg LY2922470 administered orally QD for up to 28 days. 1200 mg LY2922470 administered orally QD for up to 28 days. 150 mg LY2922470 administered orally BID for up to 28 days. 400 mg LY2922470 administered orally BID for up to 28 days.
Period Title: Overall Study
Started 16 8 8 8 9 8 9
Received Study Drug 14 8 8 8 9 8 9
Completed 12 8 8 8 8 8 8
Not Completed 4 0 0 0 1 0 1
Reason Not Completed
Withdrawal by Subject             2             0             0             0             1             0             1
Physician Decision             1             0             0             0             0             0             0
Unable to Place Catheter for Blood Draws             1             0             0             0             0             0             0
Arm/Group Title Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID Total
Hide Arm/Group Description Placebo administered orally QD or BID for up to 28 days. 60 mg LY2922470 administered orally QD for up to 28 days. 200 mg LY2922470 administered orally QD for up to 28 days. 500 mg LY2922470 administered orally QD for up to 28 days. 1200 mg LY2922470 administered orally QD for up to 28 days. 150 mg LY2922470 administered orally BID for up to 28 days. 400 mg LY2922470 administered orally BID for up to 28 days. Total of all reporting groups
Overall Number of Baseline Participants 14 8 8 8 9 8 9 64
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 8 participants 8 participants 8 participants 9 participants 8 participants 9 participants 64 participants
51.4  (9.9) 59.9  (6.6) 52.8  (8.0) 58.6  (7.8) 59.8  (7.6) 54.0  (6.4) 50.2  (9.3) 54.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 8 participants 8 participants 8 participants 9 participants 8 participants 9 participants 64 participants
Female
4
  28.6%
2
  25.0%
3
  37.5%
1
  12.5%
4
  44.4%
4
  50.0%
4
  44.4%
22
  34.4%
Male
10
  71.4%
6
  75.0%
5
  62.5%
7
  87.5%
5
  55.6%
4
  50.0%
5
  55.6%
42
  65.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 8 participants 8 participants 8 participants 9 participants 8 participants 9 participants 64 participants
Hispanic or Latino
8
  57.1%
1
  12.5%
1
  12.5%
2
  25.0%
4
  44.4%
5
  62.5%
6
  66.7%
27
  42.2%
Not Hispanic or Latino
6
  42.9%
7
  87.5%
7
  87.5%
6
  75.0%
5
  55.6%
3
  37.5%
3
  33.3%
37
  57.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
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 14 participants 8 participants 8 participants 8 participants 9 participants 8 participants 9 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
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%
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%
0
   0.0%
0
   0.0%
1
  11.1%
1
   1.6%
Black or African American
3
  21.4%
5
  62.5%
5
  62.5%
5
  62.5%
3
  33.3%
3
  37.5%
1
  11.1%
25
  39.1%
White
11
  78.6%
3
  37.5%
3
  37.5%
3
  37.5%
6
  66.7%
5
  62.5%
7
  77.8%
38
  59.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
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%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 8 participants 8 participants 8 participants 9 participants 8 participants 9 participants 64 participants
14
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
9
 100.0%
8
 100.0%
9
 100.0%
64
 100.0%
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms per square meter (kg/m²)
Number Analyzed 14 participants 8 participants 8 participants 8 participants 9 participants 8 participants 9 participants 64 participants
31.00  (4.86) 28.10  (3.19) 30.76  (3.74) 31.08  (3.40) 30.20  (6.56) 34.36  (4.04) 32.90  (6.08) 31.19  (4.89)
[1]
Measure Description: BMI is an estimate of body fat based on body weight divided by height squared.
Hemoglobin A1c (HbA1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated hemoglobin
Number Analyzed 14 participants 8 participants 8 participants 8 participants 9 participants 8 participants 9 participants 64 participants
8.29  (1.08) 8.58  (1.48) 7.74  (1.29) 7.91  (1.69) 7.24  (0.49) 8.09  (1.25) 7.96  (1.21) 7.99  (1.24)
[1]
Measure Description: HbA1c is a form of hemoglobin that is primarily measured to identify the average plasma glucose concentration over prolonged periods of time.
Fasting Blood Glucose  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter (mg/dL)
Number Analyzed 14 participants 8 participants 8 participants 8 participants 9 participants 8 participants 9 participants 64 participants
145.92  (50.50) 128.45  (39.38) 132.39  (37.09) 140.19  (49.53) 137.11  (26.19) 149.50  (38.40) 149.56  (44.21) 141.05  (40.99)
1.Primary Outcome
Title Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Hide Description A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
Time Frame Baseline through Study Completion (up to 56 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description:
Placebo administered orally QD or BID for up to 28 days.
60 mg LY2922470 administered orally QD for up to 28 days.
200 mg LY2922470 administered orally QD for up to 28 days.
500 mg LY2922470 administered orally QD for up to 28 days.
1200 mg LY2922470 administered orally QD for up to 28 days.
150 mg LY2922470 administered orally BID for up to 28 days.
400 mg LY2922470 administered orally BID for up to 28 days.
Overall Number of Participants Analyzed 14 8 8 8 9 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0
2.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470
Hide Description [Not Specified]
Time Frame Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received LY2922470 and had sufficient evaluable AUC(0-24) values.
Arm/Group Title 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description:
60 mg LY2922470 administered orally QD for up to 28 days.
200 mg LY2922470 administered orally QD for up to 28 days.
500 mg LY2922470 administered orally QD for up to 28 days.
1200 mg LY2922470 administered orally QD for up to 28 days.
150 mg LY2922470 administered orally BID for up to 28 days.
400 mg LY2922470 administered orally BID for up to 28 days.
Overall Number of Participants Analyzed 8 8 8 8 8 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
Day 1 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 9 participants
4220
(52%)
11,600
(27%)
25,100
(30%)
81,400
(34%)
21,000
(47%)
50,700
(45%)
Day 28 Number Analyzed 8 participants 7 participants 5 participants 8 participants 8 participants 8 participants
5660
(31%)
15,300
(43%)
25,000
(47%)
65,300
(49%)
21,300
(51%)
44,800
(38%)
3.Secondary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Hide Description [Not Specified]
Time Frame Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received LY2922470 and had sufficient evaluable Cmax values. For BID arms, Cmax from time 0-6 hours.
Arm/Group Title 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description:
60 mg LY2922470 administered orally QD for up to 28 days.
200 mg LY2922470 administered orally QD for up to 28 days.
500 mg LY2922470 administered orally QD for up to 28 days.
1200 mg LY2922470 administered orally QD for up to 28 days.
150 mg LY2922470 administered orally BID for up to 28 days.
400 mg LY2922470 administered orally BID for up to 28 days.
Overall Number of Participants Analyzed 8 8 8 8 8 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 9 participants
723
(39%)
1540
(23%)
2750
(42%)
8200
(38%)
1510
(54%)
3150
(58%)
Day 28 Number Analyzed 8 participants 7 participants 5 participants 8 participants 8 participants 8 participants
1070
(32%)
1630
(70%)
3410
(33%)
7900
(49%)
1540
(42%)
2980
(37%)
4.Secondary Outcome
Title Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470
Hide Description [Not Specified]
Time Frame Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received LY2922470 and had sufficient evaluable Tmax values. For BID arms, Tmax from time 0-6 hours.
Arm/Group Title 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description:
60 mg LY2922470 administered orally QD for up to 28 days.
200 mg LY2922470 administered orally QD for up to 28 days.
500 mg LY2922470 administered orally QD for up to 28 days.
1200 mg LY2922470 administered orally QD for up to 28 days.
150 mg LY2922470 administered orally BID for up to 28 days.
400 mg LY2922470 administered orally BID for up to 28 days.
Overall Number of Participants Analyzed 8 8 8 8 8 9
Median (Full Range)
Unit of Measure: hours
Day 1 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 9 participants
1.50
(1.50 to 2.50)
2.50
(1.50 to 4.00)
2.75
(1.50 to 16.0)
4.00
(1.50 to 6.00)
2.00
(1.50 to 4.00)
2.50
(1.50 to 4.00)
Day 28 Number Analyzed 8 participants 7 participants 5 participants 8 participants 8 participants 9 participants
1.50
(1.50 to 1.50)
3.92
(1.50 to 6.00)
1.50
(1.50 to 2.50)
2.50
(1.50 to 6.00)
1.51
(1.50 to 4.00)
1.50
(1.50 to 4.00)
5.Secondary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28
Hide Description [Not Specified]
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had sufficient evaluable HbA1c values.
Arm/Group Title Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description:
Placebo administered orally QD or BID for up to 28 days.
60 mg LY2922470 administered orally QD for up to 28 days.
200 mg LY2922470 administered orally QD for up to 28 days.
500 mg LY2922470 administered orally QD for up to 28 days.
1200 mg LY2922470 administered orally QD for up to 28 days.
150 mg LY2922470 administered orally BID for up to 28 days.
400 mg LY2922470 administered orally BID for up to 28 days.
Overall Number of Participants Analyzed 12 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated hemoglobin
-0.38  (0.45) -0.54  (0.32) -0.43  (0.58) -0.24  (0.52) -0.16  (0.67) -0.34  (0.38) 0.01  (0.44)
6.Secondary Outcome
Title Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀₋₂₄) During Mixed Meal Tolerance Test at Day 28
Hide Description [Not Specified]
Time Frame Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had sufficient evaluable blood glucose values.
Arm/Group Title Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description:
Placebo administered orally QD or BID for up to 28 days.
60 mg LY2922470 administered orally QD for up to 28 days.
200 mg LY2922470 administered orally QD for up to 28 days.
500 mg LY2922470 administered orally QD for up to 28 days.
1200 mg LY2922470 administered orally QD for up to 28 days.
150 mg LY2922470 administered orally BID for up to 28 days.
400 mg LY2922470 administered orally BID for up to 28 days.
Overall Number of Participants Analyzed 10 5 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: mg*h/dL
21.7  (724) -93  (165) 70.4  (1160) -499  (493) -205  (583) -531  (549) -621  (943)
7.Secondary Outcome
Title Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀₋₁₂) During Mixed Meal Tolerance Test at Day 28
Hide Description [Not Specified]
Time Frame Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had sufficient evaluable c-peptide values.
Arm/Group Title Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description:
Placebo administered orally QD or BID for up to 28 days.
60 mg LY2922470 administered orally QD for up to 28 days.
200 mg LY2922470 administered orally QD for up to 28 days.
500 mg LY2922470 administered orally QD for up to 28 days.
1200 mg LY2922470 administered orally QD for up to 28 days.
150 mg LY2922470 administered orally BID for up to 28 days.
400 mg LY2922470 administered orally BID for up to 28 days.
Overall Number of Participants Analyzed 12 8 6 8 7 6 8
Mean (Standard Deviation)
Unit of Measure: picomoles*h per liter (pmol*h/L)
665  (4970) 147  (3560) 793  (4220) -159  (3780) -740  (2890) 1230  (1660) -2230  (2810)
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least one dose of study drug.
 
Arm/Group Title Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Hide Arm/Group Description Placebo administered orally QD or BID for up to 28 days. 60 mg LY2922470 administered orally QD for up to 28 days. 200 mg LY2922470 administered orally QD for up to 28 days. 500 mg LY2922470 administered orally QD for up to 28 days. 1200 mg LY2922470 administered orally QD for up to 28 days. 150 mg LY2922470 administered orally BID for up to 28 days. 400 mg LY2922470 administered orally BID for up to 28 days.
All-Cause Mortality
Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo QD or BID 60 mg LY2922470 QD 200 mg LY2922470 QD 500 mg LY2922470 QD 1200 mg LY2922470 QD 150 mg LY2922470 BID 400 mg LY2922470 BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/14 (35.71%)      3/8 (37.50%)      4/8 (50.00%)      4/8 (50.00%)      5/9 (55.56%)      1/8 (12.50%)      6/9 (66.67%)    
Eye disorders               
Asthenopia  1  0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Vitreous floaters  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders               
Abdominal distension  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1
Constipation  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0
Diarrhoea  1  0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 2/8 (25.00%)  2 1/9 (11.11%)  2 0/8 (0.00%)  0 2/9 (22.22%)  3
Dyspepsia  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1
Faeces discoloured  1  3/14 (21.43%)  3 0/8 (0.00%)  0 0/8 (0.00%)  0 2/8 (25.00%)  3 5/9 (55.56%)  5 0/8 (0.00%)  0 3/9 (33.33%)  4
Faeces pale  1  0/14 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Frequent bowel movements  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1
Infrequent bowel movements  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1
Nausea  1  1/14 (7.14%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Paraesthesia oral  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0
Vomiting  1  1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
General disorders               
Fatigue  1  1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Pain  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Infections and infestations               
Upper respiratory tract infection  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1
Injury, poisoning and procedural complications               
Procedural site reaction  1  0/14 (0.00%)  0 0/8 (0.00%)  0 2/8 (25.00%)  2 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0
Wound  1  1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Back pain  1  0/14 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Neck pain  1  0/14 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders               
Cervicobrachial syndrome  1  0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Dizziness  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/9 (11.11%)  1
Headache  1  1/14 (7.14%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  2 2/9 (22.22%)  2 1/8 (12.50%)  2 1/9 (11.11%)  1
Somnolence  1  0/14 (0.00%)  0 1/8 (12.50%)  2 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Renal and urinary disorders               
Haematuria  1  0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Reproductive system and breast disorders               
Nipple disorder  1  1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders               
Oropharyngeal pain  1  0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders               
Dermatitis contact  1  1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Hyperhidrosis  1  1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: NCT01867216    
Other Study ID Numbers: 14797
I6K-FW-GLEB ( Other Identifier: Eli Lilly and Company )
First Submitted: May 28, 2013
First Posted: June 3, 2013
Results First Submitted: September 27, 2017
Results First Posted: July 26, 2018
Last Update Posted: July 26, 2018