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Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea (JAS)

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: NCT01195090
Recruitment Status : Completed
First Posted : September 3, 2010
Results First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Mackay Memorial Hospital
Information provided by (Responsible Party):
Sung-Chen Liu, Mackay Memorial Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Sitagliptin
Drug: pioglitazone
Enrollment 120
Recruitment Details The study was started from 01 OCT 2009 to 27 SEP 2011
Pre-assignment Details

we screened 135 patients and 120 patients were randomized in a 1: 1 ratio to one of the treatment groups.

reson for excluded: 4 patients: ALT or AST >2.5x ULN 8 patiens : withdraw informed consent 3 patiens: baseline A1C>11%

Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description add sitagliptin100mg/d to pre-study OADs add pioglitazone 30mg/d to pre-study OADs
Period Title: Overall Study
Started 60 60
Completed 54 52
Not Completed 6 8
Reason Not Completed
Adverse Event             1             2
Lost to Follow-up             2             2
Protocol Violation             3             4
Arm/Group Title Sitagliptin Pioglitazone Total
Hide Arm/Group Description add sitagliptin100mg/d to pre-study OADs add pioglitazone 30mg/d to pre-study OADs Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
  70.0%
49
  81.7%
91
  75.8%
>=65 years
18
  30.0%
11
  18.3%
29
  24.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
60.1  (8.9) 58.1  (8.3) 59.1  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
38
  63.3%
37
  61.7%
75
  62.5%
Male
22
  36.7%
23
  38.3%
45
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Mean Change in Glycosylated Hemoglobin (A1C)
Hide Description A1C change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy.
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Hb
-0.71  (0.12) -0.94  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin, Pioglitazone
Comments The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor ‘treatment’ and baseline A1C as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor ‘treatment’ and baseline A1C as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.58 to 0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
2.Primary Outcome
Title Baseline A1C
Hide Description baseline A1C
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
baseline Laboratory measurements
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: percentage of Hb
8.27  (0.86) 8.54  (0.97)
3.Primary Outcome
Title The Percentages of Patient Achieving an A1C <7%
Hide Description The percentages of patient achieving an A1C <7% at endpoint
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The percentages of patient achieving an A1C <7% at endpoint
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: percentage
28.3 28.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin, Pioglitazone
Comments Chi-square test for percentages of patient achieving an A1C <7%
Type of Statistical Test Non-Inferiority or Equivalence
Comments Chi-square test
Statistical Test of Hypothesis P-Value 0.954
Comments Chi-square test
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Chi-Square
Estimated Value 0.0034
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Changes in Fasting Plasma Glucose
Hide Description fasting serum sugar change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis with last observation carried forward was used to assess efficacy.
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: mg/dl
-23  (4.0) -36  (4.0)
5.Secondary Outcome
Title Changes in High Sensitive C-reactive Protein
Hide Description fasting high sensitive serum C-reactive protein change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: mg/dl
-0.07  (0.04) -0.19  (0.04)
6.Secondary Outcome
Title Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Hide Description HOMA-IR change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: HOMA-IR score
-0.00  (0.35) -1.56  (0.35)
7.Secondary Outcome
Title Body Weight Change
Hide Description body weight change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: kg
-0.26  (0.32) 1.34  (0.32)
8.Secondary Outcome
Title Percentages of Patients With Total Adverse Events (AE)
Hide Description percentages of total adverse events
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who had taken at least one dose of study medication were included in the safety analysis
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: percentage
43.1 51.7
9.Secondary Outcome
Title Change in Fasting Total-cholesterol
Hide Description Total-cholesterol change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy.
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: mg/dl
0.6  (3.9) 9.9  (4.0)
10.Secondary Outcome
Title Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
Hide Description LDL-C change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: mg/dl
-1.2  (3.7) 6.6  (3.7)
11.Secondary Outcome
Title Change in Fasting Triglycerides(TG)
Hide Description TG change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy.
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: mg/dl
6.3  (9.3) -23.9  (9.4)
12.Secondary Outcome
Title Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)
Hide Description HDL-C change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy.
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: mg/dl
1.3  (1.2) 6.3  (1.2)
13.Secondary Outcome
Title Change in Fasting Plasma Alanine-aminotransferase (ALT)
Hide Description ALT change from baseline to 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat analysis with last observation carried forward was used to assess efficacy
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Least Squares Mean (Standard Error)
Unit of Measure: IU/L
-0.0  (2.4) -4.5  (2.4)
14.Secondary Outcome
Title Percentages of Patients With Mild to Moderate Hypoglycemia
Hide Description Incidence of mild to moderate hypoglycemia after treatment
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who had taken at least one dose of study medication were included in the safety analysis
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: percentage
10 8.5
15.Secondary Outcome
Title Percentages of Patients With Edema
Hide Description proportion of edema after treatment
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who had taken at least one dose of study medication were included in the safety analysis
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: percentage
0 27.1
16.Secondary Outcome
Title Percentages of Patients With Gastrointestinal Adverse Events
Hide Description Proportion of Gastrointestinal adverse events after treatment
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who had taken at least one dose of study medication were included in the safety analysis
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: percentge
20.0 6.8
17.Secondary Outcome
Title Percentages of Patients With Nasopharyngitis
Hide Description Proportion of Nasopharyngitis after treatment
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who had taken at least one dose of study medication were included in the safety analysis
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: percentage
20.0 18.6
18.Secondary Outcome
Title Percentages of Patients With Severe Hypoglycemia
Hide Description Proportion of severe hypoglycemia after treatment
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Proportion of severe ypoglycemia after treatment
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: percentage
0 0
19.Secondary Outcome
Title Baseline Fasting Plasma Glucose
Hide Description Baseline fasting plasma glucose
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline fasting plasma glucose
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: mg/dl
177  (47) 182  (38)
20.Secondary Outcome
Title Baseline High Sensitive C-reactive Protein
Hide Description Baseline high sensitive C-reactive Protein
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline high sensitive C-reactive Protein
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.38  (0.36) 0.42  (0.68)
21.Secondary Outcome
Title Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Hide Description Baseline HOMA-IR
Time Frame Baseline HOMA-IR
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline HOMA-IR
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: HOMA-IR score
5.6  (3.8) 4.8  (3.2)
22.Secondary Outcome
Title Baseline Alanine-aminotransferase (ALT)
Hide Description Baseline alanine-aminotransferase
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline alanine-aminotransferase
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: IU/L
34.2  (17.5) 28.5  (15.5)
23.Secondary Outcome
Title Baseline Body Weight
Hide Description Baseline body weight
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline body weight
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: kg
69.4  (13.6) 65.4  (10.4)
24.Secondary Outcome
Title Baseline Total Cholesterol
Hide Description Baseline Total cholesterol
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline Total cholesterol
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: mg/dl
174  (31) 194  (33)
25.Secondary Outcome
Title Baseline Triglyceride (TG)
Hide Description Baseline TG
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline TG
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: mg/dl
137  (74) 164  (73)
26.Secondary Outcome
Title Baseline Low-density Lipoprotein Cholesterol (LDL-C)
Hide Description Baseline LDL-C
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline LDL-C
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: mg/dl
102  (25) 111  (31)
27.Secondary Outcome
Title Baseline High-density Lipoprotein Cholesterol (HDL-C)
Hide Description Baseline HDL-C
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline HDL-C
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description:
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: mg/dl
42  (12) 43  (12)
Time Frame adverse event was recorded after 12 weeks and 24 weeks treatment or was recorded if adverse event was noted at any time during the study period.
Adverse Event Reporting Description All adverse events was recorded after treatment. Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia and severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia in which the patient required the assistance of another person.
 
Arm/Group Title Sitagliptin Pioglitazone
Hide Arm/Group Description add sitagliptin100mg/d to pre-study OADs add pioglitazone 30mg/d to pre-study OADs
All-Cause Mortality
Sitagliptin Pioglitazone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin Pioglitazone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sitagliptin Pioglitazone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/60 (43.33%)      31/60 (51.67%)    
Gastrointestinal disorders     
Gastrointestinal adverse event  [1]  12/60 (20.00%)  12 4/60 (6.67%)  4
General disorders     
edema  [2]  0/60 (0.00%)  0 16/60 (26.67%)  16
Hypoglycemia  [3]  6/60 (10.00%)  6 5/60 (8.33%)  5
Respiratory, thoracic and mediastinal disorders     
Nasopharyngitis  [4]  12/60 (20.00%)  12 11/60 (18.33%)  11
Indicates events were collected by systematic assessment
[1]
Gastrointestinal adverse event was recorded at any visit after treatment
[2]
12 patients in the pioglitazone group had peripheral edema after treamtnet for 12 weeks and 16 patients had edema after treatment for 24 weeks. No edema in the sitagliptin group was noted.
[3]
Hypoglycemic events occurred in 5 patients in the pioglitazone group and in 6 patients in the sitagliptin group. All the adverse events were mild to moderate.
[4]
Nasopharyngitis was recorded at every visit

The reasons for withdrawal:

lost to follow-up:2 in pioglitazone and 2 in sitagliptin protocol violation:4 in pioglitazone and 3 in sitagliptin edema:1 in pioglitazone, ALT >3 times ULN:1 in pioglitazone gastrointestinal events:1 in sitagliptin

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Sung-Chen Liu
Organization: Department of Internal Medicine, Mackay Memorial Hospital
Phone: 886-2-2543-3535 ext 2174
Responsible Party: Sung-Chen Liu, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01195090     History of Changes
Other Study ID Numbers: 09MMHIS047
First Submitted: September 2, 2010
First Posted: September 3, 2010
Results First Submitted: April 18, 2012
Results First Posted: October 10, 2012
Last Update Posted: October 10, 2012