MK0431 and Pioglitazone Co-Administration Factorial Study... | NCT00722371 | Trialant
NCT00722371
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
May 12, 2017Actual
Enrollment
1,615Actual
Phase
Phase 3
Conditions
Type 2 Diabetes Mellitus
Interventions
Sitagliptin phosphate
Pioglitazone hydrochloride
Matching placebo to sitagliptin
Matching placebo to pioglitazone
Metformin
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00722371
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0431-102
Secondary IDs
ID
Type
Description
Link
2008_522
Other Identifier
Merck Study Number
Brief Title
MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
Official Title
A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Apr 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 5, 2008Actual
Primary Completion Date
Oct 26, 2010Actual
Completion Date
Mar 25, 2011Actual
First Submitted Date
Jul 22, 2008
First Submission Date that Met QC Criteria
Jul 24, 2008
First Posted Date
Jul 25, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 9, 2011
Results First Submitted that Met QC Criteria
Sep 9, 2011
Results First Posted Date
Oct 17, 2011Estimated
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
Apr 7, 2017
Last Update Posted Date
May 12, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,615Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Sitagliptin 100 mg
Experimental
Drug: Sitagliptin phosphate
Drug: Matching placebo to pioglitazone
Drug: Metformin
Pioglitazone 15 mg
Experimental
Drug: Pioglitazone hydrochloride
Drug: Matching placebo to sitagliptin
Drug: Metformin
Pioglitazone 30 mg
Experimental
Drug: Pioglitazone hydrochloride
Drug: Matching placebo to sitagliptin
Drug: Metformin
Pioglitazone 45 mg
Experimental
Drug: Pioglitazone hydrochloride
Drug: Matching placebo to sitagliptin
Drug: Metformin
Sitagliptin 100 mg/ Pioglitazone 15 mg
Experimental
Drug: Sitagliptin phosphate
Drug: Pioglitazone hydrochloride
Drug: Metformin
Sitagliptin 100 mg/ Pioglitazone 30 mg
Experimental
Drug: Sitagliptin phosphate
Drug: Pioglitazone hydrochloride
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sitagliptin phosphate
Drug
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Sitagliptin 100 mg
Sitagliptin 100 mg/ Pioglitazone 15 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Hemoglobin A1C (A1C) at Week 24
A1C represents the percentage of glycosylated hemoglobin.
Baseline and Week 24
Change From Baseline in A1C at Week 54
A1C represents the percentage of glycosylated hemoglobin.
Baseline and Week 54
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline and Week 24
Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24
PMG was measured using the Meal Tolerance Test (MTT).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient is highly unlikely to conceive
Patient meets one of the 3 categories is naïve to all antihyperglycemic agent (AHA) therapies, or is non-naïve based upon the patient's current diet, medical regimen and screening A1c patient is currently not on AHA with a screening A1c >=7.5 % and =<11.0 % patient is currently on either metformin pr sulfonylurea monotherapy with a screening A1c >=7.0 % and =<9.0 %
Exclusion Criteria
Patient has a history of type 1 diabetes mellitus or history of ketoacidosis or has C=peptide value of =<0.8 ng/mL
Patient has previously been treated with insulin, thiazolidinedione (TZD) (rosiglitazone or pioglitazone), any Dipeptidyl peptidase-4 (DPP-4) inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic
Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
Patient has undergone surgery within the prior 30 days or has major surgery planned during the study
Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis
Patient has received treatment with an investigational product within 12 weeks prior to Visit 1
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
FG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Jul 10, 2026
Removed Countries
Australia
Austria
Brazil
Bulgaria
Chile
Colombia
Costa Rica
Croatia
Ecuador
Egypt
Estonia
Greece
India
Italy
Latvia
Lebanon
Lithuania
Mexico
Peru
Philippines
Russia
Saudi Arabia
Serbia
Slovenia
South Africa
Taiwan
Turkey (Türkiye)
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Metformin
Sitagliptin 100 mg/ Pioglitazone 45 mg
Experimental
Drug: Sitagliptin phosphate
Drug: Pioglitazone hydrochloride
Drug: Metformin
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg/ Pioglitazone 45 mg
Januvia
Tesavel
Xelevia
Ristaben
Pioglitazone hydrochloride
Drug
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Pioglitazone 15 mg
Pioglitazone 30 mg
Pioglitazone 45 mg
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg/ Pioglitazone 45 mg
Actos
Matching placebo to sitagliptin
Drug
Matching placebo to sitagliptin orally once daily for 54 weeks.
Pioglitazone 15 mg
Pioglitazone 30 mg
Pioglitazone 45 mg
Matching placebo to pioglitazone
Drug
Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.
Sitagliptin 100 mg
Metformin
Drug
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Pioglitazone 15 mg
Pioglitazone 30 mg
Pioglitazone 45 mg
Sitagliptin 100 mg
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg/ Pioglitazone 45 mg
Baseline and Week 24
Change From Baseline in FPG at Week 54
Baseline and Week 54
Change From Baseline in 2-Hour PMG at Week 54
PMG was measured using the Meal Tolerance Test (MTT).
Baseline and Week 54
FG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
FG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
FG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
FG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
FG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
FG000231 subjects
FG001230 subjects
FG002233 subjects
FG003230 subjects
FG004230 subjects
FG005231 subjects
FG006230 subjects
COMPLETED
FG000175 subjects
FG001158 subjects
FG002168 subjects
FG003167 subjects
FG004182 subjects
FG005178 subjects
FG006179 subjects
NOT COMPLETED
FG00056 subjects
FG00172 subjects
FG00265 subjects
FG00363 subjects
FG00448 subjects
FG00553 subjects
FG00651 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG00113 subjects
FG0029 subjects
FG00310 subjects
FG0046 subjects
FG0058 subjects
FG0064 subjects
Contraindication
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Creatinine / Creatinine clearance
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG004
Excluded medication
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Hyperglycemia
FG0002 subjects
FG0016 subjects
FG0024 subjects
FG0032 subjects
FG004
Hypoglycemia
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0004 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG004
Lost to Follow-up
FG00011 subjects
FG00114 subjects
FG00221 subjects
FG00313 subjects
FG004
Physician Decision
FG0005 subjects
FG0012 subjects
FG0022 subjects
FG0035 subjects
FG004
Pregnancy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0006 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG00018 subjects
FG00127 subjects
FG00219 subjects
FG00323 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
BG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
BG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
BG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
BG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
BG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
BG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000231
BG001230
BG002233
BG003230
BG004230
BG005231
BG006230
BG0071615
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
<=20 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00095
BG00182
BG002
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 From Baseline in Hemoglobin A1C (A1C) at Week 24
A1C represents the percentage of glycosylated hemoglobin.
Full Analysis Set with last observation carried forward (LOCF). Reasons for exclusion included no baseline data and/or no post-baseline data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage of glycosylated hemoglobin
Baseline and Week 24
ID
Title
Description
OG000
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
OG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
OG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
OG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
Units
Counts
Participants
OG000172
OG001163
OG002181
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.09(-1.29 to -0.89)
OG001-0.88(-1.09 to -0.68)
OG002-1.21(-1.41 to -1.02)
OG003
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Baseline and Week 24
ID
Title
Description
OG000
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
OG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Secondary
Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24
PMG was measured using the Meal Tolerance Test (MTT).
Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Baseline and Week 24
ID
Title
Description
OG000
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
OG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Primary
Change From Baseline in A1C at Week 54
A1C represents the percentage of glycosylated hemoglobin.
Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
Posted
Least Squares Mean
95% Confidence Interval
Percent of glycosylated hemoglobin
Baseline and Week 54
ID
Title
Description
OG000
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
OG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Secondary
Change From Baseline in FPG at Week 54
Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Baseline and Week 54
ID
Title
Description
OG000
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
OG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
Secondary
Change From Baseline in 2-Hour PMG at Week 54
PMG was measured using the Meal Tolerance Test (MTT).
Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Baseline and Week 54
ID
Title
Description
OG000
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
OG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
OG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Time Frame
Not provided
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
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
14
231
60
231
EG001
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
10
230
41
230
EG002
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
5
233
45
233
EG003
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
11
230
55
230
EG004
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
12
230
48
230
EG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
15
231
56
231
EG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
7
230
46
230
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina unstable
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG0030 events0 affected230 at risk
EG0040 events0 affected230 at risk
EG0051 events1 affected231 at risk
EG0060 events0 affected230 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Mitral valve disease
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Dengue fever
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Wound infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0021 events1 affected233 at risk
EG003
Splenic haematoma
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0021 events1 affected233 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Prostate cancer stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0021 events1 affected233 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Complicated migraine
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0021 events1 affected233 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0021 events1 affected233 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0010 events0 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected231 at risk
EG0011 events1 affected230 at risk
EG0020 events0 affected233 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG00013 events13 affected231 at risk
EG00111 events10 affected230 at risk
EG00216 events12 affected233 at risk
EG00310 events9 affected230 at risk
EG00415 events12 affected230 at risk
EG00519 events15 affected231 at risk
EG00610 events8 affected230 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG00013 events10 affected231 at risk
EG0016 events6 affected230 at risk
EG0029 events8 affected233 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG00057 events25 affected231 at risk
EG00130 events20 affected230 at risk
EG00278 events22 affected233 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG00018 events17 affected231 at risk
EG0018 events6 affected230 at risk
EG0029 events9 affected233 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0008 events7 affected231 at risk
EG0015 events5 affected230 at risk
EG0024 events4 affected233 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068900
Sitagliptin Phosphate
D000077205
Pioglitazone
D008687
Metformin
Ancestor Terms
ID
Term
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D011719
Pyrazines
D045162
Thiazolidinediones
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001645
Biguanides
D006146
Guanidines
D000578
Amidines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0051 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0061 subjects
5 subjects
FG0051 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0053 subjects
FG0060 subjects
8 subjects
FG00516 subjects
FG00613 subjects
2 subjects
FG0053 subjects
FG0064 subjects
0 subjects
FG0051 subjects
FG0060 subjects
4 subjects
FG0052 subjects
FG0061 subjects
19 subjects
FG00518 subjects
FG00626 subjects
0
BG0040
BG0050
BG0060
BG0070
21 to 30 years
Title
Measurements
BG0005
BG0016
BG0022
BG0035
BG0045
BG0058
BG0064
BG00735
31 to 40 years
Title
Measurements
BG00037
BG00139
BG00233
BG00320
BG00417
BG00534
BG00615
BG007195
41 to 50 years
Title
Measurements
BG00064
BG00173
BG00260
BG00370
BG00473
BG00560
BG00668
BG007468
51 to 60 years
Title
Measurements
BG00083
BG00167
BG00288
BG00376
BG00480
BG00575
BG00687
BG007556
61 to 70 years
Title
Measurements
BG00031
BG00134
BG00245
BG00353
BG00444
BG00549
BG00651
BG007307
>70 years
Title
Measurements
BG00011
BG00111
BG0025
BG0036
BG00411
BG0055
BG0065
BG00754
106
BG003117
BG004112
BG00596
BG00695
BG007703
Male
BG000136
BG001148
BG002127
BG003113
BG004118
BG005135
BG006135
BG007912
171
OG004179
OG005173
OG006188
-1.20
(-1.40 to -1.00)
OG004-1.53(-1.73 to -1.34)
OG005-1.63(-1.82 to -1.43)
OG006-1.81(-2.00 to -1.62)
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
OG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
OG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
Units
Counts
Participants
OG000179
OG001176
OG002185
OG003181
OG004189
OG005181
OG006193
Title
Denominators
Categories
Title
Measurements
OG000-24.3(-32.0 to -16.5)
OG001-19.5(-27.2 to -11.7)
OG002-29.9(-37.6 to -22.3)
OG003-37.4(-45.1 to -29.7)
OG004-41.0(-48.5 to -33.5)
OG005-46.9(-54.6 to -39.3)
OG006-52.0(-59.6 to -44.5)
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
OG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
OG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
Units
Counts
Participants
OG000141
OG001128
OG002158
OG003136
OG004149
OG005143
OG006154
Title
Denominators
Categories
Title
Measurements
OG000-51.1(-64.0 to -38.2)
OG001-30.6(-44.0 to -17.3)
OG002-52.5(-64.9 to -40.2)
OG003-66.6(-79.8 to -53.5)
OG004-69.2(-81.7 to -56.7)
OG005-85.5(-98.4 to -72.6)
OG006-93.8(-106.4 to -81.2)
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
OG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
OG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
Units
Counts
Participants
OG000172
OG001163
OG002181
OG003171
OG004179
OG005173
OG006188
Title
Denominators
Categories
Title
Measurements
OG000-0.93(-1.15 to -0.72)
OG001-0.74(-0.96 to -0.53)
OG002-1.16(-1.37 to -0.95)
OG003-1.23(-1.45 to -1.02)
OG004-1.45(-1.65 to -1.24)
OG005-1.49(-1.71 to -1.28)
OG006-1.78(-1.99 to -1.58)
OG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
OG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
Units
Counts
Participants
OG000179
OG001176
OG002185
OG003181
OG004189
OG005181
OG006193
Title
Denominators
Categories
Title
Measurements
OG000-13.1(-21.6 to -4.5)
OG001-10.5(-19.0 to -2.0)
OG002-24.0(-32.4 to -15.5)
OG003-33.3(-41.8 to -24.8)
OG004-33.9(-42.2 to -25.7)
OG005-37.1(-45.5 to -28.6)
OG006-47.8(-56.1 to -39.5)
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
OG005
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
OG006
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.