ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY2189265 and Sitagliptin in Participants With Type 2 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: NCT01408888
Recruitment Status : Completed
First Posted : August 3, 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: LY2189265
Drug: Sitagliptin
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2189265, Sitagliptin + LY2189265 Sitagliptin + LY2189265, LY2189265
Hide Arm/Group Description

First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).

Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).

There was a washout of at least 21 days between treatments.

First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).

Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).

There was a washout of at least 21 days between treatments.

Period Title: First Intervention
Started 18 11
Received at Least 1 Dose of Drug 18 11
Completed 18 8
Not Completed 0 3
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             0             2
Period Title: Washout of at Least 21 Days
Started 18 8
Completed 18 8
Not Completed 0 0
Period Title: Second Intervention
Started 18 8
Completed 16 8
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             1             0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
52.7  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
10
  34.5%
Male
19
  65.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Hispanic or Latino
5
  17.2%
Not Hispanic or Latino
24
  82.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  13.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
14
  48.3%
White
11
  37.9%
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 29 participants
29
1.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin
Hide Description Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (24 hours) is summarized.
Time Frame Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of sitagliptin with evaluable sitagliptin AUC data.
Arm/Group Title 100 mg Sitagliptin (Day 4) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
Hide Arm/Group Description:
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
Overall Number of Participants Analyzed 28 29 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms times hour/milliliter(ng*h/mL)
3210
(34%)
3240
(36%)
2970
(54%)
2.Primary Outcome
Title Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin
Hide Description [Not Specified]
Time Frame Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of sitagliptin with evaluable sitagliptin Cmax data.
Arm/Group Title 100 mg Sitagliptin (Day 4) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
Hide Arm/Group Description:
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg of LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
Overall Number of Participants Analyzed 28 29 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
417
(46%)
374
(61%)
318
(77%)
3.Secondary Outcome
Title Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin
Hide Description [Not Specified]
Time Frame Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of sitagliptin with evaluable sitagliptin tmax data
Arm/Group Title 100 mg Sitagliptin (Day 4) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)
Hide Arm/Group Description:
Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
Overall Number of Participants Analyzed 28 29 27
Median (Full Range)
Unit of Measure: hours
1.00
(0.500 to 4.00)
2.00
(0.500 to 16.0)
2.00
(0.500 to 12.0)
4.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265
Hide Description Area under the LY2189265 pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (168 hours) is summarized.
Time Frame Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2189265 with evaluable LY2189265 AUC data.
Arm/Group Title 1.5 mg LY2189265 (Day 1) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)
Hide Arm/Group Description:
Sitagliptin + LY2189265: A single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
Overall Number of Participants Analyzed 26 27 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms times hour/milliliter(ng*h/mL)
6590
(40%)
8890
(26%)
13900
(26%)
5.Secondary Outcome
Title Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265
Hide Description [Not Specified]
Time Frame Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2189265 with evaluable LY2189265 Cmax data.
Arm/Group Title 1.5 mg LY2189265 (Day 1) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)
Hide Arm/Group Description:
Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
Overall Number of Participants Analyzed 26 29 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
52.9
(37%)
68.1
(25%)
101
(28%)
6.Secondary Outcome
Title Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265
Hide Description [Not Specified]
Time Frame Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2189265 with evaluable LY2189265 tmax data.
Arm/Group Title 1.5 mg LY2189265 (Day 1) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5) 100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)
Hide Arm/Group Description:
Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
Overall Number of Participants Analyzed 26 29 26
Median (Full Range)
Unit of Measure: hours
72.0
(12.0 to 120)
72.0
(48.0 to 144)
59.8
(12.0 to 120)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2189265 Sitagliptin Sitagliptin + LY2189265
Hide Arm/Group Description

LY2189265: a single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously on Day 1 of Treatment 1

Time frame: Treatment 1

Sitagliptin: 100-mg dose of sitagliptin, administered orally, once daily before the LY2189265 dose on Day 1 to Day 5 of Treatment 2.

Time Frame: Day 1 to Day 5 of Treatment 2

Sitagliptin + LY2189265: 100-mg dose of sitagliptin administered orally, once daily from Day 5 to Day 18 of Treatment 2 in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 of Treatment 2.

Time Frame: Day 5 to end of Treatment 2

All-Cause Mortality
LY2189265 Sitagliptin Sitagliptin + LY2189265
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2189265 Sitagliptin Sitagliptin + LY2189265
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/29 (0.00%)      2/29 (6.90%)    
Infections and infestations       
Pneumonia bacterial  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Injury, poisoning and procedural complications       
Concussion  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Renal and urinary disorders       
Renal failure acute  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
LY2189265 Sitagliptin Sitagliptin + LY2189265
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/26 (42.31%)      10/29 (34.48%)      16/29 (55.17%)    
Cardiac disorders       
Palpitations  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Eye disorders       
Chalazion  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Dry eye  1  0/26 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Gastrointestinal disorders       
Abdominal discomfort  1  2/26 (7.69%)  2 0/29 (0.00%)  0 0/29 (0.00%)  0
Abdominal distension  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Abdominal pain  1  0/26 (0.00%)  0 0/29 (0.00%)  0 2/29 (6.90%)  2
Constipation  1  1/26 (3.85%)  1 0/29 (0.00%)  0 1/29 (3.45%)  1
Diarrhoea  1  1/26 (3.85%)  1 0/29 (0.00%)  0 2/29 (6.90%)  2
Dry mouth  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Dyspepsia  1  2/26 (7.69%)  2 0/29 (0.00%)  0 1/29 (3.45%)  1
Faeces hard  1  0/26 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Flatulence  1  1/26 (3.85%)  1 1/29 (3.45%)  1 0/29 (0.00%)  0
Gastrooesophageal reflux disease  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Gingival pain  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Haematochezia  1  0/26 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Lip dry  1  0/26 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
Nausea  1  1/26 (3.85%)  2 0/29 (0.00%)  0 4/29 (13.79%)  6
Toothache  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Vomiting  1  1/26 (3.85%)  1 1/29 (3.45%)  1 2/29 (6.90%)  2
General disorders       
Fatigue  1  3/26 (11.54%)  3 1/29 (3.45%)  1 2/29 (6.90%)  2
Feeling jittery  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Injection site pain  1  2/26 (7.69%)  2 0/29 (0.00%)  0 1/29 (3.45%)  1
Pyrexia  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Swelling  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Vessel puncture site haematoma  1  0/26 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
Immune system disorders       
Seasonal allergy  1  0/26 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Infections and infestations       
Trichomoniasis  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Injury, poisoning and procedural complications       
Arthropod bite  1  1/26 (3.85%)  2 0/29 (0.00%)  0 0/29 (0.00%)  0
Contusion  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  1/26 (3.85%)  1 0/29 (0.00%)  0 4/29 (13.79%)  5
Dehydration  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Hypoglycaemia  1  1/26 (3.85%)  2 1/29 (3.45%)  1 4/29 (13.79%)  12
Musculoskeletal and connective tissue disorders       
Back pain  1  0/26 (0.00%)  0 0/29 (0.00%)  0 2/29 (6.90%)  2
Nervous system disorders       
Dizziness  1  0/26 (0.00%)  0 1/29 (3.45%)  4 1/29 (3.45%)  1
Dizziness postural  1  0/26 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Headache  1  4/26 (15.38%)  4 1/29 (3.45%)  1 5/29 (17.24%)  5
Paraesthesia  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Sinus headache  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Somnolence  1  0/26 (0.00%)  0 2/29 (6.90%)  3 0/29 (0.00%)  0
Psychiatric disorders       
Insomnia  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Restlessness  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Nasal congestion  1  1/26 (3.85%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Productive cough  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/26 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01408888     History of Changes
Other Study ID Numbers: 14361
H9X-MC-GBDW ( Other Identifier: Eli Lilly and Company )
First Submitted: August 2, 2011
First Posted: August 3, 2011
Results First Submitted: October 3, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014