Dose Range Finding Study of MK-0941 in Patients With Type... | NCT00767000 | Trialant
NCT00767000
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Feb 19, 2015Estimated
Enrollment
813Actual
Phase
Phase 2
Conditions
Diabetes Mellitus, Type 2
Interventions
MK-0941
Comparator: Placebo
Lantus
Metformin
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00767000
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0941-007
Secondary IDs
ID
Type
Description
Link
2008_557
Brief Title
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Official Title
A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2015
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2008
Primary Completion Date
Apr 2010Actual
Completion Date
Jun 2010Actual
First Submitted Date
Oct 3, 2008
First Submission Date that Met QC Criteria
Oct 3, 2008
First Posted Date
Oct 6, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 19, 2012
Results First Submitted that Met QC Criteria
Jul 31, 2012
Results First Posted Date
Sep 3, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 2, 2015
Last Update Posted Date
Feb 19, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.
Detailed Description
This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
813Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-0941 10 mg
Experimental
Drug: MK-0941
Biological: Lantus
Drug: Metformin
MK-0941 20 mg
Experimental
Drug: MK-0941
Biological: Lantus
Drug: Metformin
MK-0941 30 mg
Experimental
Drug: MK-0941
Biological: Lantus
Drug: Metformin
MK-0941 40 mg
Experimental
Drug: MK-0941
Biological: Lantus
Drug: Metformin
Placebo
Placebo Comparator
Drug: Comparator: Placebo
Biological: Lantus
Drug: Metformin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-0941
Drug
MK-0941 tablets three times daily
MK-0941 10 mg
MK-0941 20 mg
MK-0941 30 mg
MK-0941 40 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in Hemoglobin A1c (HbA1c) Level
Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Experienced at Least One Adverse Event
Entire study including 54-week study and 104-week extension
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Entire study including 54-week study and 104-week extension
Secondary Outcomes
Measure
Description
Time Frame
Change in the Two-hour Post Meal Glucose Level
Least squares mean change from baseline in 2-hour post meal glucose level.
Baseline and Weeks 14, 54, 106, and 158
Change in the Fasting Plasma Glucose Level
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
has type 2 diabetes mellitus
has body mass index >20 and <43 kg/m^2
is a male, or a female who is unlikely to conceive
currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus
Extension Study Inclusion Criteria:
completed the base study either on double-blind study medication or as part of the post-treatment follow up population
had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period
Exclusion Criteria:
has any history of Type 1 diabetes mellitus or ketoacidosis
has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
has undergone surgery within 30 days prior to Visit 1 or has planned major surgery
Meininger GE, Scott R, Alba M, Shentu Y, Luo E, Amin H, Davies MJ, Kaufman KD, Goldstein BJ. Effects of MK-0941, a novel glucokinase activator, on glycemic control in insulin-treated patients with type 2 diabetes. Diabetes Care. 2011 Dec;34(12):2560-6. doi: 10.2337/dc11-1200. Epub 2011 Oct 12.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
FG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
FG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
FG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
FG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
Periods
Title
Milestones
Reasons Not Completed
54-week Study
Type
Comment
Milestone Data
STARTED
FG000119 subjects
FG001117 subjects
FG002117 subjects
FG003229 subjectsIncludes additional participants enrolled to enhance evaluation of the safety profile of MK-0941
FG004231 subjectsIncludes additional participants enrolled to enhance evaluation of the safety profile of MK-0941
COMPLETED
FG00011 subjects
FG0014 subjects
FG0028 subjects
FG0034 subjects
FG004
NOT COMPLETED
FG000108 subjects
FG001113 subjects
FG002109 subjects
FG003225 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0016 subjects
FG0026 subjects
FG003
Optional 104-week Extension
Type
Comment
Milestone Data
STARTED
FG0007 subjectsThe extension study was optional. Not all participants completing the 54-week study continued.
FG0013 subjectsThe extension study was optional. Not all participants completing the 54-week study continued.
FG0027 subjectsThe extension study was optional. Not all participants completing the 54-week study continued.
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
BG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in Hemoglobin A1c (HbA1c) Level
Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent HbA1c
Baseline and Weeks 14, 54, 106, and 158
ID
Title
Description
OG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
OG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
Adverse Events Module
Frequency Threshold
5
Time Frame
Adverse events were collected for the entire study including the 54-week study and 104-week extension
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute coronary syndrome
Cardiac disorders
MedDRA 13.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cataract
Eye disorders
MedDRA 13.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.
MK-0941 10 mg
MK-0941 20 mg
MK-0941 30 mg
MK-0941 40 mg
Placebo
Least squares mean change from baseline in fasting plasma glucose.
Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Achieve an HbA1c of <7.0%
Weeks 106 and 158
Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
Weeks 54, 106 and 158
7 subjects
224 subjects
8 subjects
FG0044 subjects
Creaninine/creatinine clearance
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0044 subjects
Hyperglycemia
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
Hypoglycemia
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Interruption of study medication
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Lack of Efficacy
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0045 subjects
Lost to Follow-up
FG0004 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
FG0042 subjects
Physician Decision
FG0004 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
Progressive disease
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
Withdrawal by Subject
FG0002 subjects
FG0013 subjects
FG0025 subjects
FG00311 subjects
FG00413 subjects
Study terminated by sponsor
FG00090 subjects
FG001102 subjects
FG00289 subjects
FG003196 subjects
FG004194 subjects
Reason not reported
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
2 subjects
The extension study was optional. Not all participants completing the 54-week study continued.
FG0044 subjectsThe extension study was optional. Not all participants completing the 54-week study continued.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0007 subjects
FG0013 subjects
FG0027 subjects
FG0032 subjects
FG0044 subjects
Type
Comment
Reasons
Study terminated by sponsor
FG0007 subjects
FG0013 subjects
FG0027 subjects
FG0032 subjects
FG0044 subjects
BG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
BG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
BG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
BG005
Total
Total of all reporting groups
119
BG001117
BG002117
BG003229
BG004231
BG005813
participants
Title
Denominators
Categories
26 to 71 years
Title
Measurements
BG000119
BG001117
BG002117
BG003229
BG004231
BG005813
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00067
BG00157
BG00254
BG003123
BG004115
BG005416
Male
BG00052
BG00160
BG00263
BG003106
BG004
OG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
OG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
OG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
Units
Counts
Participants
OG000118
OG001117
OG002117
OG003118
OG004115
Title
Denominators
Categories
Week 14
Title
Measurements
OG000-0.59(-0.80 to -0.38)
OG001-0.72(-0.92 to -0.52)
OG002-0.89(-1.10 to -0.69)
OG003-0.83(-1.03 to -0.62)
OG004-0.08(-0.28 to 0.13)
Week 54 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
Week 106 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
Week 158 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Analysis for change from baseline to Week 14
Constrained longitudinal model
<0.001
Least Squares Mean Difference
-0.51
95
-0.80
-0.22
No
Superiority or Other
OG001
OG004
Analysis for change from baseline to Week 14
Constrained longitudinal model
<0.001
Least Squares Mean Difference
-0.64
95
-0.93
-0.36
No
Superiority or Other
OG002
OG004
Analysis for change from baseline to Week 14
Contrained longitudinal model
<0.001
Least Squares Mean Difference
-0.81
95
-1.10
-0.53
No
Superiority or Other
OG003
OG004
Analysis for change from baseline to Week 14
Constrained longitudinal model
<0.001
Least Squares Mean Difference
-0.75
95
-1.04
-0.46
No
Superiority or Other
Secondary
Change in the Two-hour Post Meal Glucose Level
Least squares mean change from baseline in 2-hour post meal glucose level.
Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Baseline and Weeks 14, 54, 106, and 158
ID
Title
Description
OG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
OG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
OG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
OG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
OG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
Units
Counts
Participants
OG000112
OG001114
OG002113
OG003
Title
Denominators
Categories
Week 14
Title
Measurements
OG000-39.0(-52.0 to -25.1)
OG001-29.2(-42.5 to -15.9)
OG002-37.4(-51.2 to -23.6)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Analysis for change from baseline to Week 14
Constrained longitudial model
<0.001
Least Squares Mean Difference
-36.6
95
-55.6
-17.5
No
Superiority or Other
OG001
OG004
Analysis for change from baseline to Week 14
Constrained longitudinal model
Secondary
Change in the Fasting Plasma Glucose Level
Least squares mean change from baseline in fasting plasma glucose.
Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Baseline and Weeks 14, 54, 106, and 158
ID
Title
Description
OG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
OG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
OG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
OG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
OG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
Units
Counts
Participants
OG000118
OG001117
OG002117
OG003
Title
Denominators
Categories
Week 14
Title
Measurements
OG000-10.0(-19.9 to 0.0)
OG001-1.5(-10.9 to 7.9)
OG002-21.1(-30.9 to -11.2)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Analysis for change from baseline to Week 14
Constrained longitudinal model
0.791
Least Squares Mean Difference
1.8
95
-11.6
15.2
No
Superiority or Other
OG001
OG004
Analysis for change from baseline to Week 14
Constrained longitudinal model
Secondary
Percentage of Participants Who Achieve an HbA1c of <7.0%
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158
Posted
Weeks 106 and 158
ID
Title
Description
OG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
OG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
OG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
OG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
OG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158
Posted
Weeks 54, 106 and 158
ID
Title
Description
OG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
OG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
OG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
OG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
OG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Primary
Percentage of Participants Who Experienced at Least One Adverse Event
Full analysis set. Includes additional participants enrolled in the MK-0941 40 mg and placebo groups to enhance evaluation of the safety profile of MK-0941.
Posted
Number
percentage of participants
Entire study including 54-week study and 104-week extension
ID
Title
Description
OG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
OG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
OG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
OG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
OG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
Units
Counts
Participants
OG000119
OG001117
OG002117
OG003
Title
Denominators
Categories
Title
Measurements
OG00080.7
OG00179.5
OG00280.3
OG003
Primary
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Posted
Number
percentage of participants
Entire study including 54-week study and 104-week extension
ID
Title
Description
OG000
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
OG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
OG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
OG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
OG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
Units
Counts
Participants
OG000119
OG001117
OG002117
OG003229
Title
Denominators
Categories
Title
Measurements
OG0003.4
OG0015.1
OG0026.8
OG003
11
119
74
119
EG001
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
12
117
75
117
EG002
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
11
117
78
117
EG003
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
13
229
120
229
EG004
Placebo
Placebo three times daily plus insulin once daily with or without metformin
8
231
101
231
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0041 events1 affected231 at risk
Angina pectoris
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Atrial flutter
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Coronary artery disease
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Myocardial infarction
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0012 events2 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0041 events1 affected231 at risk
Palpitations
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Cataract
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Macular hole
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Macular oedema
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Retinal haemorrhage
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Constipation
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Chest pain
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0022 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Cyst rupture
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Death
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Sarcoidosis
Immune system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Anal abscess
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Cellulitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Gangrene
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0041 events1 affected231 at risk
Gastroenteritis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Postoperative wound infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Respiratory tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Staphylococcal infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Urinary tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Viral infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Wound infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0041 events1 affected231 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Foot fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Head injury
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0022 events2 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Rib fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Colon cancer stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Colon cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0041 events1 affected231 at risk
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Cerebral infarction
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0041 events1 affected231 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Diabetic neuropathy
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Headache
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Syncope
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0041 events1 affected231 at risk
Calculus ureteric
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
Calculus urinary
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0041 events1 affected231 at risk
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0012 events2 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Ovarian mass
Reproductive system and breast disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Arterial haemorrhage
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Hypertension
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected229 at risk
EG0040 events0 affected231 at risk
Hypertensive crisis
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected119 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected229 at risk
EG0040 events0 affected231 at risk
EG00013 events10 affected119 at risk
EG00116 events12 affected117 at risk
EG00222 events17 affected117 at risk
EG00311 events10 affected229 at risk
EG00420 events20 affected231 at risk
Diabetic retinopathy
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0003 events3 affected119 at risk
EG0018 events6 affected117 at risk
EG0028 events6 affected117 at risk
EG0034 events4 affected229 at risk
EG0043 events3 affected231 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0009 events7 affected119 at risk
EG0019 events7 affected117 at risk
EG0024 events4 affected117 at risk
EG00313 events8 affected229 at risk
EG00422 events11 affected231 at risk
Influenza
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0007 events6 affected119 at risk
EG0014 events4 affected117 at risk
EG0029 events8 affected117 at risk
EG00314 events10 affected229 at risk
EG00410 events8 affected231 at risk
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG00010 events8 affected119 at risk
EG00114 events13 affected117 at risk
EG00212 events12 affected117 at risk
EG00316 events12 affected229 at risk
EG00412 events10 affected231 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG00011 events10 affected119 at risk
EG0017 events6 affected117 at risk
EG00216 events11 affected117 at risk
EG00314 events11 affected229 at risk
EG0047 events6 affected231 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG000425 events57 affected119 at risk
EG001475 events58 affected117 at risk
EG002719 events57 affected117 at risk
EG003690 events94 affected229 at risk
EG004350 events67 affected231 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0007 events7 affected119 at risk
EG0011 events1 affected117 at risk
EG0021 events1 affected117 at risk
EG0033 events3 affected229 at risk
EG0046 events6 affected231 at risk
Headache
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0008 events4 affected119 at risk
EG00112 events12 affected117 at risk
EG0026 events5 affected117 at risk
EG00316 events13 affected229 at risk
EG0048 events7 affected231 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
D004700
Endocrine System Diseases
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D001645
Biguanides
D006146
Guanidines
D000578
Amidines
D009930
Organic Chemicals
116
BG005397
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
115
OG004111
-39.3
(-53.1 to -25.5)
OG004-2.4(-16.0 to 11.2)
Week 54 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
Week 106 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
Week 158 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
0.005
Least Squares Mean Difference
-26.7
95
-45.4
-8.1
No
Superiority or Other
OG002
OG004
Analysis for change from baseline to Week 14
Constrained longitudinal model
<0.001
Least Squares Mean Difference
-35.0
95
-54.0
-16.0
No
Superiority or Other
OG003
OG004
Analysis for change from baseline to Week 14
Constrained longitudinal model
<0.001
Least Squares Mean Difference
-36.9
95
-55.9
-17.9
No
Superiority or Other
118
OG004115
-5.0
(-14.9 to 4.8)
OG004-11.8(-21.4 to -2.1)
Week 54 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
Week 106 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
Week 158 (no participants analyzed)
Title
Measurements
OG000NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG001NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG002NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG003NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
OG004NA(NA to NA)Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158