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Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes (DIET™)

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ClinicalTrials.gov Identifier: NCT01232491
Recruitment Status : Completed
First Posted : November 2, 2010
Results First Posted : December 11, 2012
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: Insulin detemir
Dietary Supplement: Dietary regimen
Enrollment 611
Recruitment Details The trial was conducted at 110 sites in 9 countries: Argentina (5), Germany (7), Poland (4), Serbia (4), Slovakia (3), Slovenia (2), Spain (4), Turkey (5) and United States of America (76).
Pre-assignment Details Subjects continued on their treatment with metformin, at the pre-randomisation dose level and dosing frequency. All other oral antidiabetic drugs were discontinued before insulin detemir was used.
Arm/Group Title Dietician Control
Hide Arm/Group Description Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted. Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Period Title: Overall Study
Started 306 305
Exposed (Safety Analysis Set) 305 [1] 301 [2]
Completed 246 242
Not Completed 60 63
Reason Not Completed
Adverse Event             13             8
Lack of Efficacy             1             5
Protocol Violation             13             11
Withdrawal Criteria             12             21
Other             21             18
[1]
One subject withdrew prior to exposure to trial drug.
[2]
Four subjects withdrew prior to exposure to trial drug.
Arm/Group Title Dietician Control Total
Hide Arm/Group Description Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted. Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted. Total of all reporting groups
Overall Number of Baseline Participants 305 301 606
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 305 participants 301 participants 606 participants
58.2  (9.7) 56.5  (10.0) 57.4  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 301 participants 606 participants
Female
152
  49.8%
143
  47.5%
295
  48.7%
Male
153
  50.2%
158
  52.5%
311
  51.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 305 participants 301 participants 606 participants
White 274 268 542
Black or African American 21 26 47
Asian 2 5 7
American Indian or Alaska Native 0 0 0
Native Hawaiian or Oth. Pacific Islander 3 0 3
Other 5 2 7
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 305 participants 301 participants 606 participants
Hispanic or Latino 63 78 141
Not Hispanic or Latino 242 223 465
Height  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 305 participants 301 participants 606 participants
1.67  (0.10) 1.68  (0.10) 1.67  (0.10)
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 305 participants 301 participants 606 participants
96.4  (18.2) 97.0  (20.4) 96.7  (19.3)
Body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 305 participants 301 participants 606 participants
34.4  (5.4) 34.3  (5.6) 34.4  (5.5)
Duration of diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 305 participants 301 participants 606 participants
8.6  (5.8) 8.5  (6.0) 8.6  (5.9)
[1]
Measure Description: The number of subjects (N) analysed in the Dietician group was 303 instead of 305.
Fasting plasma glucose (FPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 305 participants 301 participants 606 participants
9.3  (2.3) 9.2  (2.0) 9.2  (2.2)
[1]
Measure Description: The number of subjects (N) analysed in the Control group was 298 instead of 301.
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 305 participants 301 participants 606 participants
8.0  (0.7) 7.9  (0.6) 7.9  (0.6)
1.Primary Outcome
Title Change From Baseline in Body Weight
Hide Description Estimated mean change from baseline in body weight after 26 weeks of treatment.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Arm/Group Title Dietician Control
Hide Arm/Group Description:
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Overall Number of Participants Analyzed 306 305
Least Squares Mean (Standard Error)
Unit of Measure: kg
-1.05  (0.23) -0.56  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietician, Control
Comments Normal linear regression model with treatment, strata, use of insulin secretagogue at screening, sex and region as factors and age and weight at baseline as covariates. Superiority was considered confirmed if the upper bound of the two-sided 95% CI for the estimated treatment difference (dietary intervention versus no dietary intervention), which was calculated using the FAS, was below 0 kg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.132
Comments If the p-value for the two-sided test was less than 5%, and D (the estimated treatment difference [dietary intervention versus no dietary intervention]) was less than 0 then superiority for dietary intervention was considered confirmed.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.49
Confidence Interval 95%
-0.15 to 1.13
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Body Mass Index (BMI)
Hide Description Estimated mean change from baseline in BMI after 26 weeks of treatment.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Arm/Group Title Dietician Control
Hide Arm/Group Description:
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Overall Number of Participants Analyzed 306 305
Least Squares Mean (Standard Error)
Unit of Measure: kg/m^2
-0.37  (0.08) -0.20  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietician, Control
Comments Normal linear regression model with treatment, use of insulin secretagogue at screening, sex and region as factors, and age and BMI at baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.17
Confidence Interval 95%
-0.05 to 0.39
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Hide Description Estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Arm/Group Title Dietician Control
Hide Arm/Group Description:
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Overall Number of Participants Analyzed 306 305
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated haemoglobin
-0.93  (0.05) -0.80  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietician, Control
Comments Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and HbA1c at baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.13
Confidence Interval 95%
-0.00 to 0.26
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG)
Hide Description Estimated mean change from baseline in FPG after 26 weeks of treatment.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Arm/Group Title Dietician Control
Hide Arm/Group Description:
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Overall Number of Participants Analyzed 306 302
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-3.00  (0.12) -2.93  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietician, Control
Comments Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and FPG at baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.674
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.07
Confidence Interval 95%
-0.25 to 0.39
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Rate of Treatment Emergent Adverse Events (TEAEs)
Hide Description Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time Frame Week 0 to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set includes all subjects who received at least one dose of insulin detemir.
Arm/Group Title Dietician Control
Hide Arm/Group Description:
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Overall Number of Participants Analyzed 305 301
Measure Type: Number
Unit of Measure: rate per 100 years of patient exposure
All TEAEs 387.9 437.1
Serious TEAEs 16.3 16.6
Severe TEAEs 16.3 11.3
Moderate TEAEs 130.5 108.3
Mild TEAEs 241.0 317.5
6.Secondary Outcome
Title Rate of All Treatment Emergent Hypoglycaemic Episodes
Hide Description Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.
Time Frame Week 0 to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set includes all subjects who received at least one dose of insulin detemir.
Arm/Group Title Dietician Control
Hide Arm/Group Description:
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Overall Number of Participants Analyzed 305 301
Measure Type: Number
Unit of Measure: rate per year of patient exposure
All Events 25.47 23.30
Severe Events 0.01 0.01
7.Secondary Outcome
Title Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes
Hide Description Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.
Time Frame Week 0 to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set includes all subjects who received at least one dose of insulin detemir.
Arm/Group Title Dietician Control
Hide Arm/Group Description:
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
Overall Number of Participants Analyzed 305 301
Measure Type: Number
Unit of Measure: rate per year of patient exposure
All Events 5.59 5.51
Severe Events 0.01 0.01
Time Frame The adverse events were collected in a time frame of 26 weeks.
Adverse Event Reporting Description Safety analysis set includes all subjects who received at least one dose of insulin detemir.
 
Arm/Group Title Dietician Control
Hide Arm/Group Description Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted. Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
All-Cause Mortality
Dietician Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dietician Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/305 (5.57%)      19/301 (6.31%)    
Cardiac disorders     
Acute coronary syndrome  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Acute myocardial infarction  1  1/305 (0.33%)  1 2/301 (0.66%)  2
Angina pectoris  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Cardiac disorder  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Congestive cardiomyopathy  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Myocardial infarction  1  1/305 (0.33%)  1 1/301 (0.33%)  1
Myocardial ischaemia  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Tachycardia  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Ear and labyrinth disorders     
Vertigo positional  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Eye disorders     
Retinal vein thrombosis  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Gastrointestinal disorders     
Gastritis  1  0/305 (0.00%)  0 1/301 (0.33%)  1
General disorders     
Chest pain  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Infections and infestations     
Anal abscess  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Bronchitis  1  1/305 (0.33%)  1 1/301 (0.33%)  1
Bursitis infective  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Lobar pneumonia  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Pneumonia  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Viral infection  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Wrist fracture  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/305 (0.33%)  2 0/301 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Metastases to central nervous system  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Nervous system disorders     
Lumbar radiculopathy  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Migraine with aura  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Psychiatric disorders     
Depression  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Schizophrenia  1  1/305 (0.33%)  3 0/301 (0.00%)  0
Renal and urinary disorders     
Calculus bladder  1  1/305 (0.33%)  1 0/301 (0.00%)  0
Calculus urinary  1  1/305 (0.33%)  1 1/301 (0.33%)  1
Nephrolithiasis  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Obstructive uropathy  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Reproductive system and breast disorders     
Endometrial hypertrophy  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/305 (0.00%)  0 2/301 (0.66%)  2
Vascular disorders     
Hypertension  1  0/305 (0.00%)  0 1/301 (0.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dietician Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/305 (20.00%)      69/301 (22.92%)    
General disorders     
Injection site reaction  1  16/305 (5.25%)  21 13/301 (4.32%)  17
Infections and infestations     
Nasopharyngitis  1  30/305 (9.84%)  39 38/301 (12.62%)  49
Nervous system disorders     
Headache  1  23/305 (7.54%)  29 24/301 (7.97%)  36
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.
Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
Results Point of Contact
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01232491     History of Changes
Other Study ID Numbers: NN304-3785
U1111-1116-2629 ( Other Identifier: WHO )
2009-014894-42 ( EudraCT Number )
First Submitted: October 29, 2010
First Posted: November 2, 2010
Results First Submitted: November 14, 2012
Results First Posted: December 11, 2012
Last Update Posted: May 1, 2017