ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)

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: NCT01698775
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : February 23, 2017
Last Update Posted : August 9, 2018
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: Placebo to omarigliptin
Drug: Glipizide
Drug: Placebo to glipizide
Biological: Insulin
Enrollment 213
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Hide Arm/Group Description Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54). Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Period Title: Phase A
Started 107 106
Completed 98 97
Not Completed 9 9
Reason Not Completed
Adverse Event             2             1
Death             1             1
Lack of Efficacy             1             0
Lost to Follow-up             1             2
Protocol Violation             1             0
Withdrawal by Subject             3             4
Kidney [transplant]             0             1
Period Title: Phase B
Started 98 97
Completed 84 86
Not Completed 14 11
Reason Not Completed
Hyperglycemia Discontinuation Criteria             0             1
Adverse Event             6             3
Death             0             1
Lack of Efficacy             0             1
Lost to Follow-up             0             1
Physician Decision             1             1
Protocol Violation             1             1
Withdrawal by Subject             6             2
Arm/Group Title Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A) Total
Hide Arm/Group Description Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 107 106 213
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 106 participants 213 participants
65.9  (9.4) 64.5  (9.7) 65.2  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 106 participants 213 participants
Female
39
  36.4%
43
  40.6%
82
  38.5%
Male
68
  63.6%
63
  59.4%
131
  61.5%
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24
Hide Description A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.
Arm/Group Title Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Overall Number of Participants Analyzed 106 106
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.77
(-1.00 to -0.54)
-0.44
(-0.67 to -0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.63 to -0.02
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Time Frame Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment.
Arm/Group Title Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Overall Number of Participants Analyzed 106 106
Measure Type: Number
Unit of Measure: Percentage of participants
66.0 69.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-16.3 to 8.8
Estimation Comments Based on Miettinen & Nurminen method stratified by renal status stratum.
3.Primary Outcome
Title Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Time Frame Up to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APaT population consists of all randomized participants who took at least 1 dose of trial treatment.
Arm/Group Title Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Overall Number of Participants Analyzed 106 106
Measure Type: Number
Unit of Measure: Percentage of participants
2.8 0.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-2.6 to 7.2
Estimation Comments Based on Miettinen & Nurminen method stratified by renal status stratum.
4.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Time Frame Up to 58 weeks (including 28 days following the last dose of study therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APaT population consists of all randomized participants who took at least 1 dose of trial treatment.
Arm/Group Title Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Overall Number of Participants Analyzed 106 106
Measure Type: Number
Unit of Measure: Percentage of participants
77.4 78.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A) → Omarigliptin (Phase B), Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-12.2 to 10.3
Estimation Comments Based on Miettinen & Nurminen method stratified by renal status stratum.
5.Primary Outcome
Title Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Time Frame Up to 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APaT population consists of all randomized participants who took at least 1 dose of trial treatment.
Arm/Group Title Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Overall Number of Participants Analyzed 106 106
Measure Type: Number
Unit of Measure: Percentage of participants
6.6 3.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A) → Omarigliptin (Phase B), Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-3.6 to 9.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.
Arm/Group Title Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Overall Number of Participants Analyzed 106 106
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-24.6
(-35.6 to -13.6)
-20.7
(-31.8 to -9.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.540
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-16.5 to 8.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in A1C at Week 54
Hide Description A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Time Frame Baseline and Week 54
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.
Arm/Group Title Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Overall Number of Participants Analyzed 106 106
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.79
(-1.10 to -0.47)
-0.83
(-1.16 to -0.49)
8.Secondary Outcome
Title Change From Baseline in FPG at Week 54
Hide Description Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Time Frame Baseline and Week 54
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.
Arm/Group Title Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Overall Number of Participants Analyzed 106 106
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-19.3
(-36.5 to -2.1)
-16.4
(-34.4 to 1.6)
9.Secondary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Hide Description Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes participants on dialysis and data after initiation of dialysis. One omarigliptin participant with severe renal impairment was misclassified as ESRD on dialysis in Phase A and was excluded from the Phase A analysis (corrected in Phase B).
Arm/Group Title Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Overall Number of Participants Analyzed 85 83
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/min/1.73 m^2
-0.5
(-2.1 to 1.2)
-0.0
(-1.8 to 1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method cLDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.7 to 1.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in eGFR at Week 54
Hide Description Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.
Time Frame Baseline and Week 54
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis. Phase B includes 1 omarigliptin participant in the severe renal impairment stratum (not on dialysis) who was misclassified in the ESRD stratum on dialysis during Phase A.
Arm/Group Title Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Hide Arm/Group Description:
Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Overall Number of Participants Analyzed 86 83
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/min/1.73 m^2
-2.0
(-4.0 to -0.1)
-2.3
(-4.3 to -0.2)
Time Frame Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up)
Adverse Event Reporting Description APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
 
Arm/Group Title Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A) Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Hide Arm/Group Description Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54). Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
All-Cause Mortality
Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A) Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A) Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/106 (9.43%)      13/106 (12.26%)      22/106 (20.75%)      22/106 (20.75%)    
Cardiac disorders         
Cardiac disorder  1  1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Cardiac failure acute  1  1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Cardio-respiratory arrest  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
Coronary artery stenosis  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
Acute coronary syndrome  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Acute myocardial infarction  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 1/106 (0.94%)  1
Angina pectoris  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Atrial fibrillation  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Cardiac failure congestive  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Coronary artery disease  1  1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Eye disorders         
Diabetic retinopathy  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
General disorders         
Device malfunction  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
General physical health deterioration  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Vascular stent restenosis  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Infections and infestations         
Gastroenteritis  1  1/106 (0.94%)  1 1/106 (0.94%)  1 1/106 (0.94%)  1 1/106 (0.94%)  1
Hepatitis C  1  1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Peritonitis  1  1/106 (0.94%)  1 1/106 (0.94%)  1 1/106 (0.94%)  1 2/106 (1.89%)  2
Pneumonia  1  0/106 (0.00%)  0 2/106 (1.89%)  2 0/106 (0.00%)  0 2/106 (1.89%)  3
Bronchitis  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Enterococcal sepsis  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Infected dermal cyst  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Influenza  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Septic shock  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Upper respiratory tract infection  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Wound infection  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Injury, poisoning and procedural complications         
Coronary artery restenosis  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
Ankle fracture  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Arteriovenous fistula thrombosis  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Subdural haematoma  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Vascular pseudoaneurysm  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Wound  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Arteriovenous fistula site complication  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
Investigations         
Blood glucose decreased  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Metabolism and nutrition disorders         
Hyperkalaemia  1  2/106 (1.89%)  2 0/106 (0.00%)  0 2/106 (1.89%)  4 0/106 (0.00%)  0
Fluid retention  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Gout  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Hyperglycaemia  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Hypoglycaemia  1  1/106 (0.94%)  1 0/106 (0.00%)  0 2/106 (1.89%)  2 0/106 (0.00%)  0
Hyponatraemia  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Musculoskeletal and connective tissue disorders         
Gouty arthritis  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Meningioma  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Nervous system disorders         
Carotid artery stenosis  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Cerebrovascular accident  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Hemiparesis  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Renal and urinary disorders         
Nephrolithiasis  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
Acute kidney injury  1  0/106 (0.00%)  0 0/106 (0.00%)  0 2/106 (1.89%)  2 0/106 (0.00%)  0
Chronic kidney disease  1  1/106 (0.94%)  1 0/106 (0.00%)  0 3/106 (2.83%)  3 0/106 (0.00%)  0
Renal impairment  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  1/106 (0.94%)  1 0/106 (0.00%)  0 2/106 (1.89%)  2 0/106 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pulmonary congestion  1  1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  3 0/106 (0.00%)  0
Pulmonary oedema  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
Acute pulmonary oedema  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 2/106 (1.89%)  2
Aspiration  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Respiratory arrest  1  0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1
Vascular disorders         
Arterial thrombosis  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
Arteriovenous fistula  1  0/106 (0.00%)  0 1/106 (0.94%)  1 1/106 (0.94%)  1 1/106 (0.94%)  1
Hypotension  1  0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1
Peripheral arterial occlusive disease  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Peripheral ischaemia  1  1/106 (0.94%)  1 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Subclavian artery stenosis  1  0/106 (0.00%)  0 0/106 (0.00%)  0 1/106 (0.94%)  1 0/106 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omarigliptin (Phase A) Placebo to Omarigliptin (Phase A) Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/106 (22.64%)      25/106 (23.58%)      44/106 (41.51%)      52/106 (49.06%)    
General disorders         
Oedema peripheral  1  0/106 (0.00%)  0 2/106 (1.89%)  2 4/106 (3.77%)  4 7/106 (6.60%)  7
Infections and infestations         
Upper respiratory tract infection  1  4/106 (3.77%)  4 8/106 (7.55%)  9 4/106 (3.77%)  4 12/106 (11.32%)  14
Nasopharyngitis  1  2/106 (1.89%)  2 4/106 (3.77%)  5 3/106 (2.83%)  3 6/106 (5.66%)  7
Urinary tract infection  1  3/106 (2.83%)  3 2/106 (1.89%)  2 7/106 (6.60%)  8 3/106 (2.83%)  3
Investigations         
Blood creatinine phosphokinase increased  1  4/106 (3.77%)  4 3/106 (2.83%)  3 6/106 (5.66%)  6 2/106 (1.89%)  2
Blood glucose increased  1  1/106 (0.94%)  1 4/106 (3.77%)  4 7/106 (6.60%)  25 6/106 (5.66%)  6
Metabolism and nutrition disorders         
Hypoglycaemia  1  21/106 (19.81%)  84 19/106 (17.92%)  88 27/106 (25.47%)  138 25/106 (23.58%)  161
Respiratory, thoracic and mediastinal disorders         
Cough  1  4/106 (3.77%)  5 2/106 (1.89%)  2 6/106 (5.66%)  7 3/106 (2.83%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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.
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. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01698775     History of Changes
Other Study ID Numbers: 3102-019
2012-002332-85 ( EudraCT Number )
First Submitted: October 1, 2012
First Posted: October 3, 2012
Results First Submitted: January 3, 2017
Results First Posted: February 23, 2017
Last Update Posted: August 9, 2018