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Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

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: NCT01703221
Recruitment Status : Completed
First Posted : October 10, 2012
Results First Posted : October 29, 2015
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Omarigliptin
Drug: Sitagliptin
Drug: Placebo to omarigliptin
Drug: Placebo to sitagliptin
Enrollment 414
Recruitment Details Forty-eight sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. One hundred and seventeen participants were not randomized; the most common reason for participants not being randomized was screen failure.
Pre-assignment Details In Phase A, participants were randomized to receive either omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.
Arm/Group Title Omarigliptin (Phase A+B) Sitagliptin (Phase A) Switching to Omarigliptin (Phase B) Placebo (Phase A) Switching to Omarigliptin (Phase B)
Hide Arm/Group Description Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B) Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Period Title: Phase A (Up to 24 Weeks)
Started 166 165 83
Completed 159 161 80
Not Completed 7 4 3
Reason Not Completed
Adverse Event             2             4             0
Lack of Efficacy             2             0             1
Physician Decision             1             0             0
Withdrawal by Subject             2             0             1
Protocol Violation             0             0             1
Period Title: Phase B - (Week 25 to 52)
Started 159 161 80
Completed 143 147 75
Not Completed 16 14 5
Reason Not Completed
Withdrawal by Subject             2             1             0
Adverse Event             2             3             2
Lack of Efficacy             12             10             3
Arm/Group Title Omarigliptin (Phase A+B) Sitagliptin (Phase A) Switching to Omarigliptin (Phase B) Placebo (Phase A) Switching to Omarigliptin (Phase B) Total
Hide Arm/Group Description Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B) Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) Total of all reporting groups
Overall Number of Baseline Participants 166 165 83 414
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 165 participants 83 participants 414 participants
60  (11) 60  (9) 61  (9) 60  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 165 participants 83 participants 414 participants
Female
62
  37.3%
50
  30.3%
26
  31.3%
138
  33.3%
Male
104
  62.7%
115
  69.7%
57
  68.7%
276
  66.7%
1.Primary Outcome
Title Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24
Hide Description HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.
Arm/Group Title Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A)
Hide Arm/Group Description:
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
Placebo for 24 weeks (Phase A)
Overall Number of Participants Analyzed 166 164 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent HbA1c
-0.66
(-0.76 to -0.57)
-0.65
(-0.74 to -0.55)
0.13
(-0.00 to 0.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Placebo (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior oral antihyperglycemic agent (AHA), time, time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-0.96 to -0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sitagliptin (Phase A), Placebo (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-0.94 to -0.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Sitagliptin (Phase A)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Omarigliptin will be considered non-inferior to sitagliptin if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in least squares means for change from baseline in HbA1c at Week 24 (omarigliptin minus sitagliptin) is not more than 0.3% (non-inferiority margin).
Statistical Test of Hypothesis P-Value 0.792
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.15 to 0.12
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event During Phase A
Hide Description An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one study drug.
Arm/Group Title Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A)
Hide Arm/Group Description:
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
Placebo for 24 weeks (Phase A)
Overall Number of Participants Analyzed 166 164 82
Measure Type: Number
Unit of Measure: Percentage of participants
50.0 49.4 65.9
3.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
Hide Description An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.
Arm/Group Title Omarigliptin (Phase A+B) Omarigliptin (Phase B)-S Omarigliptin (Phase B)-P
Hide Arm/Group Description:
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
Overall Number of Participants Analyzed 166 161 80
Measure Type: Number
Unit of Measure: Percentage of Participants
69.9 47.2 56.3
4.Primary Outcome
Title Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
Hide Description An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The ASaT Population consisted of all randomized participants who received at least one study drug.
Arm/Group Title Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A)
Hide Arm/Group Description:
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
Placebo for 24 weeks (Phase A)
Overall Number of Participants Analyzed 166 164 82
Measure Type: Number
Unit of Measure: Percentage of participants
0.6 1.2 0
5.Primary Outcome
Title Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
Hide Description An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The ASaT Population consisted of all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.
Arm/Group Title Omarigliptin (Phase A+B) Omarigliptin (Phase B)-S Omarigliptin (Phase B)-P
Hide Arm/Group Description:
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
Overall Number of Participants Analyzed 166 161 80
Measure Type: Number
Unit of Measure: Percentage of participants
2.4 1.2 1.3
6.Secondary Outcome
Title Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24
Hide Description Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.
Arm/Group Title Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A)
Hide Arm/Group Description:
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
Placebo for 24 weeks (Phase A)
Overall Number of Participants Analyzed 166 164 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-42.38
(-49.53 to -35.23)
-45.24
(-52.31 to -38.16)
-5.48
(-15.13 to 4.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Placebo (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -36.89
Confidence Interval (2-Sided) 95%
-48.46 to -25.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sitagliptin (Phase A), Placebo (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -39.76
Confidence Interval (2-Sided) 95%
-51.28 to -28.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Sitagliptin (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.555
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value 2.86
Confidence Interval (2-Sided) 95%
-6.67 to 12.39
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24
Hide Description Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.
Arm/Group Title Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A)
Hide Arm/Group Description:
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
Placebo for 24 weeks (Phase A)
Overall Number of Participants Analyzed 166 164 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-18.52
(-21.81 to -15.22)
-20.75
(-24.10 to -17.39)
-6.23
(-10.84 to -1.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Placebo (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -12.28
Confidence Interval (2-Sided) 95%
-17.78 to -6.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sitagliptin (Phase A), Placebo (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -14.51
Confidence Interval (2-Sided) 95%
-20.04 to -8.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Sitagliptin (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.330
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value 2.23
Confidence Interval (2-Sided) 95%
-2.27 to 6.73
Estimation Comments [Not Specified]
Time Frame Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
Adverse Event Reporting Description The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
 
Arm/Group Title Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A) Omarigliptin (Phase A + B) Omarigliptin (Phase B)-S Omarigliptin (Phase B)-P
Hide Arm/Group Description Omarigliptin 25 mg once weekly for 24 weeks (Phase A) Sitagliptin 50 mg once daily for 24 weeks (Phase A) Placebo for 24 weeks (Phase A) Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B) Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
All-Cause Mortality
Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A) Omarigliptin (Phase A + B) Omarigliptin (Phase B)-S Omarigliptin (Phase B)-P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A) Omarigliptin (Phase A + B) Omarigliptin (Phase B)-S Omarigliptin (Phase B)-P
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   3/166 (1.81%)      3/164 (1.83%)      0/82 (0.00%)      6/166 (3.61%)      2/161 (1.24%)      0/80 (0.00%)    
Cardiac disorders             
Angina unstable  1  0/166 (0.00%)  0 0/164 (0.00%)  0 0/82 (0.00%)  0 0/166 (0.00%)  0 1/161 (0.62%)  1 0/80 (0.00%)  0
Sick sinus syndrome  1  0/166 (0.00%)  0 1/164 (0.61%)  1 0/82 (0.00%)  0 0/166 (0.00%)  0 0/161 (0.00%)  0 0/80 (0.00%)  0
Gastrointestinal disorders             
Inguinal hernia  1  0/166 (0.00%)  0 1/164 (0.61%)  1 0/82 (0.00%)  0 0/166 (0.00%)  0 0/161 (0.00%)  0 0/80 (0.00%)  0
Hepatobiliary disorders             
Bile duct stone  1  1/166 (0.60%)  1 0/164 (0.00%)  0 0/82 (0.00%)  0 1/166 (0.60%)  1 0/161 (0.00%)  0 0/80 (0.00%)  0
Cholecystitis acute  1  0/166 (0.00%)  0 0/164 (0.00%)  0 0/82 (0.00%)  0 0/166 (0.00%)  0 1/161 (0.62%)  1 0/80 (0.00%)  0
Infections and infestations             
Nasopharyngitis  1  0/166 (0.00%)  0 0/164 (0.00%)  0 0/82 (0.00%)  0 0/166 (0.00%)  0 1/161 (0.62%)  1 0/80 (0.00%)  0
Pneumonia  1  0/166 (0.00%)  0 0/164 (0.00%)  0 0/82 (0.00%)  0 1/166 (0.60%)  1 0/161 (0.00%)  0 0/80 (0.00%)  0
Injury, poisoning and procedural complications             
Limb traumatic amputation  1  0/166 (0.00%)  0 0/164 (0.00%)  0 0/82 (0.00%)  0 1/166 (0.60%)  1 0/161 (0.00%)  0 0/80 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Intervertebral disc disorder  1  1/166 (0.60%)  1 0/164 (0.00%)  0 0/82 (0.00%)  0 1/166 (0.60%)  1 0/161 (0.00%)  0 0/80 (0.00%)  0
Trigger finger  1  1/166 (0.60%)  2 0/164 (0.00%)  0 0/82 (0.00%)  0 1/166 (0.60%)  2 0/161 (0.00%)  0 0/80 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Prostate cancer  1  0/166 (0.00%)  0 0/164 (0.00%)  0 0/82 (0.00%)  0 1/166 (0.60%)  1 0/161 (0.00%)  0 0/80 (0.00%)  0
Metastases to bone  1  0/166 (0.00%)  0 1/164 (0.61%)  1 0/82 (0.00%)  0 0/166 (0.00%)  0 0/161 (0.00%)  0 0/80 (0.00%)  0
Vascular disorders             
Aortic aneurysm  1  1/166 (0.60%)  1 0/164 (0.00%)  0 0/82 (0.00%)  0 1/166 (0.60%)  1 0/161 (0.00%)  0 0/80 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omarigliptin (Phase A) Sitagliptin (Phase A) Placebo (Phase A) Omarigliptin (Phase A + B) Omarigliptin (Phase B)-S Omarigliptin (Phase B)-P
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   21/166 (12.65%)      18/164 (10.98%)      25/82 (30.49%)      45/166 (27.11%)      22/161 (13.66%)      17/80 (21.25%)    
Infections and infestations             
Nasopharyngitis  1  21/166 (12.65%)  24 18/164 (10.98%)  22 25/82 (30.49%)  27 45/166 (27.11%)  58 22/161 (13.66%)  30 17/80 (21.25%)  21
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01703221    
Other Study ID Numbers: 3102-020
132239 ( Registry Identifier: JAPIC-CTI )
First Submitted: October 5, 2012
First Posted: October 10, 2012
Results First Submitted: September 29, 2015
Results First Posted: October 29, 2015
Last Update Posted: August 28, 2019