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)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01698775
Collaborator
(none)
213
2
39.6
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of omarigliptin in participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end stage renal disease on dialysis with inadequate glycemic control. The primary hypothesis of the study is that omarigliptin compared to placebo produces greater reduction in glycosylated hemoglobin (A1C) after 24 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
213 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control.
Actual Study Start Date
:
Oct 2, 2012
Actual Primary Completion Date
:
Jan 19, 2016
Actual Study Completion Date
:
Jan 19, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Omarigliptin (Phase A) → Omarigliptin (Phase B) 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 are 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) will receive matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54). |
Drug: Omarigliptin
Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week
Other Names:
Drug: Glipizide
Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are 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) will receive glipizide capsule(s) 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).
Other Names:
Drug: Placebo to glipizide
Matching placebo to glipizide daily
Biological: Insulin
Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.
|
| Active Comparator: Placebo to omarigliptin (Phase A) → Glipizide (Phase B) 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 are 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) will receive 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). |
Drug: Placebo to omarigliptin
Matching placebo to omarigliptin capsule administered orally once a week
Drug: Glipizide
Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are 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) will receive glipizide capsule(s) 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).
Other Names:
Drug: Placebo to glipizide
Matching placebo to glipizide daily
Biological: Insulin
Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 [Baseline and Week 24]
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.
- Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period) [Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)]
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.
- Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period) [Up to 24 weeks]
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.
- Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) [Up to 58 weeks (including 28 days following the last dose of study therapy)]
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.
- 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) [Up to 54 weeks]
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.
Secondary Outcome Measures
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [Baseline and Week 24]
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.
- Change From Baseline in A1C at Week 54 [Baseline and Week 54]
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.
- Change From Baseline in FPG at Week 54 [Baseline and Week 54]
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.
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 [Baseline and Week 24]
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.
- Change From Baseline in eGFR at Week 54 [Baseline and Week 54]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Type 2 diabetes mellitus and be at least 30 years of age
-
Moderate or severe chronic renal insufficiency or end stage renal disease on dialysis
-
Meet one of the following criteria:
-
is currently not on an antihyperglycemic agent (AHA) and has A1C >=7% and <=10% at screening
-
is currently on a single oral AHA or low-dose dual oral combination AHA and has A1C >=6.5% and <=9% at screening
-
is currently on a stable insulin regimen (>= 15 U/day) for >= 10 weeks, with no oral AHA, and has A1C >=7.5% and <=10% and FPG >130 mg/dL at screening
- (1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 28 days after the last dose of study drug
Exclusion Criteria:
-
History of type 1 diabetes mellitus or a history of ketoacidosis
-
Treated with any incretin mimetic or thiazolidinedione (TZD) within 12 weeks prior to screening or with omarigliptin at any time prior to study participation
-
History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
-
History of intolerance or hypersensitivity to glipizide or insulin glargine or any contraindication to glipizide or insulin glargine
-
On a weight loss program and is not in the maintenance phase, or has been on a weight loss medication in the past 6 months, or has undergone bariatric surgery within 12 months prior to study participation
-
Undergone a surgical procedure within 4 weeks prior to screening or has planned major surgery during the trial
-
On or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal or topical corticosteroids are permitted)
-
Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
-
If on dialysis, does not regularly adhere to dialysis schedule
-
Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class IV
-
Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
-
Human immunodeficiency virus (HIV)
-
New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke, or transient ischemic neurological disorder within the past 3 months
-
Poorly controlled hypertension
-
Severe active peripheral vascular disease
-
History of malignancy <=5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
-
Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
-
Positive pregnancy test
-
Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the trial, including 28 days following the last dose of study drug
-
User of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT01698775
Other Study ID Numbers:
- 3102-019
- 2012-002332-85
First Posted:
Oct 3, 2012
Last Update Posted:
Aug 9, 2018
Last Verified:
Sep 1, 2017
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Omarigliptin (Phase A) → Omarigliptin (Phase B) | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) |
|---|---|---|
| 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 |
| Period Title: Phase A | ||
| STARTED | 98 | 97 |
| COMPLETED | 84 | 86 |
| NOT COMPLETED | 14 | 11 |
Baseline Characteristics
| Arm/Group Title | Omarigliptin (Phase A) | Placebo to Omarigliptin (Phase A) | Total |
|---|---|---|---|
| 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 Participants | 107 | 106 | 213 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
65.9
(9.4)
|
64.5
(9.7)
|
65.2
(9.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
39
36.4%
|
43
40.6%
|
82
38.5%
|
| Male |
68
63.6%
|
63
59.4%
|
131
61.5%
|
Outcome Measures
| Title | Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 106 | 106 |
| Least Squares Mean (95% Confidence Interval) [Percent] |
-0.77
|
-0.44
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.035 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in least squares means |
| Estimated Value | -0.33 | |
| Confidence Interval |
(2-Sided) 95% -0.63 to -0.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period) |
|---|---|
| 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) |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 106 | 106 |
| Number [Percentage of participants] |
66.0
61.7%
|
69.8
65.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentages |
| Estimated Value | -3.8 | |
| Confidence Interval |
(2-Sided) 95% -16.3 to 8.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Miettinen & Nurminen method stratified by renal status stratum. | |
| Title | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period) |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 106 | 106 |
| Number [Percentage of participants] |
2.8
2.6%
|
0.9
0.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentages |
| Estimated Value | 1.9 | |
| Confidence Interval |
(2-Sided) 95% -2.6 to 7.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Miettinen & Nurminen method stratified by renal status stratum. | |
| 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) |
|---|---|
| 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) |
Outcome Measure Data
| 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) |
|---|---|---|
| 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). |
| Measure Participants | 106 | 106 |
| Number [Percentage of participants] |
77.4
72.3%
|
78.3
73.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | -0.9 | |
| Confidence Interval |
(2-Sided) 95% -12.2 to 10.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Miettinen & Nurminen method stratified by renal status stratum. | |
| 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) |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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). |
| Measure Participants | 106 | 106 |
| Number [Percentage of participants] |
6.6
6.2%
|
3.8
3.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | 2.8 | |
| Confidence Interval |
(2-Sided) 95% -3.6 to 9.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 106 | 106 |
| Least Squares Mean (95% Confidence Interval) [mg/dL] |
-24.6
|
-20.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.540 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in least squares means |
| Estimated Value | -3.9 | |
| Confidence Interval |
(2-Sided) 95% -16.5 to 8.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in A1C at Week 54 |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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). |
| Measure Participants | 106 | 106 |
| Least Squares Mean (95% Confidence Interval) [Percent] |
-0.79
|
-0.83
|
| Title | Change From Baseline in FPG at Week 54 |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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). |
| Measure Participants | 106 | 106 |
| Least Squares Mean (95% Confidence Interval) [mg/dL] |
-19.3
|
-16.4
|
| Title | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 85 | 83 |
| Least Squares Mean (95% Confidence Interval) [mL/min/1.73 m^2] |
-0.5
|
-0.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Omarigliptin (Phase A), Placebo to Omarigliptin (Phase A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.720 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in least squares means |
| Estimated Value | -0.4 | |
| Confidence Interval |
(2-Sided) 95% -2.7 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in eGFR at Week 54 |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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). |
| Measure Participants | 86 | 83 |
| Least Squares Mean (95% Confidence Interval) [mL/min/1.73 m^2] |
-2.0
|
-2.3
|
Adverse Events
| 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) | ||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
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 (9.4%) | 13/106 (12.3%) | 22/106 (20.8%) | 22/106 (20.8%) | ||||
| Cardiac disorders | ||||||||
| Cardiac disorder | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Cardiac failure acute | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Cardio-respiratory arrest | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Coronary artery stenosis | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Acute coronary syndrome | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Acute myocardial infarction | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 1/106 (0.9%) | 1 |
| Angina pectoris | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Atrial fibrillation | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Cardiac failure congestive | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Coronary artery disease | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Eye disorders | ||||||||
| Diabetic retinopathy | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| General disorders | ||||||||
| Device malfunction | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| General physical health deterioration | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Vascular stent restenosis | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Infections and infestations | ||||||||
| Gastroenteritis | 1/106 (0.9%) | 1 | 1/106 (0.9%) | 1 | 1/106 (0.9%) | 1 | 1/106 (0.9%) | 1 |
| Hepatitis C | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Peritonitis | 1/106 (0.9%) | 1 | 1/106 (0.9%) | 1 | 1/106 (0.9%) | 1 | 2/106 (1.9%) | 2 |
| Pneumonia | 0/106 (0%) | 0 | 2/106 (1.9%) | 2 | 0/106 (0%) | 0 | 2/106 (1.9%) | 3 |
| Bronchitis | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Enterococcal sepsis | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Infected dermal cyst | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Influenza | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Septic shock | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Upper respiratory tract infection | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Wound infection | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Coronary artery restenosis | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Ankle fracture | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Arteriovenous fistula thrombosis | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Subdural haematoma | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Vascular pseudoaneurysm | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Wound | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Arteriovenous fistula site complication | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Investigations | ||||||||
| Blood glucose decreased | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Hyperkalaemia | 2/106 (1.9%) | 2 | 0/106 (0%) | 0 | 2/106 (1.9%) | 4 | 0/106 (0%) | 0 |
| Fluid retention | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Gout | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Hyperglycaemia | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Hypoglycaemia | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 2/106 (1.9%) | 2 | 0/106 (0%) | 0 |
| Hyponatraemia | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Gouty arthritis | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Meningioma | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Nervous system disorders | ||||||||
| Carotid artery stenosis | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Cerebrovascular accident | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Hemiparesis | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Renal and urinary disorders | ||||||||
| Nephrolithiasis | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Acute kidney injury | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 2/106 (1.9%) | 2 | 0/106 (0%) | 0 |
| Chronic kidney disease | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 3/106 (2.8%) | 3 | 0/106 (0%) | 0 |
| Renal impairment | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Reproductive system and breast disorders | ||||||||
| Benign prostatic hyperplasia | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 2/106 (1.9%) | 2 | 0/106 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pulmonary congestion | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 3 | 0/106 (0%) | 0 |
| Pulmonary oedema | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Acute pulmonary oedema | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 2/106 (1.9%) | 2 |
| Aspiration | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Respiratory arrest | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Vascular disorders | ||||||||
| Arterial thrombosis | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Arteriovenous fistula | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 1/106 (0.9%) | 1 | 1/106 (0.9%) | 1 |
| Hypotension | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 |
| Peripheral arterial occlusive disease | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Peripheral ischaemia | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
| Subclavian artery stenosis | 0/106 (0%) | 0 | 0/106 (0%) | 0 | 1/106 (0.9%) | 1 | 0/106 (0%) | 0 |
Other (Not Including 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 | 24/106 (22.6%) | 25/106 (23.6%) | 44/106 (41.5%) | 52/106 (49.1%) | ||||
| General disorders | ||||||||
| Oedema peripheral | 0/106 (0%) | 0 | 2/106 (1.9%) | 2 | 4/106 (3.8%) | 4 | 7/106 (6.6%) | 7 |
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 4/106 (3.8%) | 4 | 8/106 (7.5%) | 9 | 4/106 (3.8%) | 4 | 12/106 (11.3%) | 14 |
| Nasopharyngitis | 2/106 (1.9%) | 2 | 4/106 (3.8%) | 5 | 3/106 (2.8%) | 3 | 6/106 (5.7%) | 7 |
| Urinary tract infection | 3/106 (2.8%) | 3 | 2/106 (1.9%) | 2 | 7/106 (6.6%) | 8 | 3/106 (2.8%) | 3 |
| Investigations | ||||||||
| Blood creatinine phosphokinase increased | 4/106 (3.8%) | 4 | 3/106 (2.8%) | 3 | 6/106 (5.7%) | 6 | 2/106 (1.9%) | 2 |
| Blood glucose increased | 1/106 (0.9%) | 1 | 4/106 (3.8%) | 4 | 7/106 (6.6%) | 25 | 6/106 (5.7%) | 6 |
| Metabolism and nutrition disorders | ||||||||
| Hypoglycaemia | 21/106 (19.8%) | 84 | 19/106 (17.9%) | 88 | 27/106 (25.5%) | 138 | 25/106 (23.6%) | 161 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 4/106 (3.8%) | 5 | 2/106 (1.9%) | 2 | 6/106 (5.7%) | 7 | 3/106 (2.8%) | 3 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| ClinicalTrialsDisclosure@merck.com |
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT01698775
Other Study ID Numbers:
- 3102-019
- 2012-002332-85
First Posted:
Oct 3, 2012
Last Update Posted:
Aug 9, 2018
Last Verified:
Sep 1, 2017