Trial · NCT00722371

MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

NCT00722371, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2011-10-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2). Trials, record NCT00722371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00722371

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
NCT number: NCT00722371
Status: Completed
Phases: Phase 3
Enrollment: 1,615 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Type 2 Diabetes Mellitus
Interventions: Sitagliptin phosphate, Pioglitazone hydrochloride, Matching placebo to sitagliptin, Matching placebo to pioglitazone, Metformin
First posted: 2008-07-25
Last updated: 2017-05-12
Results first posted: 2011-10-17

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Baseline and Week 24	A1C represents the percentage of glycosylated hemoglobin.
Primary	Change From Baseline in A1C at Week 54	Baseline and Week 54	A1C represents the percentage of glycosylated hemoglobin.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline and Week 24
Secondary	Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24	Baseline and Week 24	PMG was measured using the Meal Tolerance Test (MTT).
Secondary	Change From Baseline in FPG at Week 54	Baseline and Week 54
Secondary	Change From Baseline in 2-Hour PMG at Week 54	Baseline and Week 54	PMG was measured using the Meal Tolerance Test (MTT).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Baseline and Week 24	Full Analysis Set with last observation carried forward (LOCF). Reasons for exclusion included no baseline data and/or no post-baseline data.	Percentage of glycosylated hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline and Week 24	Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24	Baseline and Week 24	Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.	mg/dL	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in A1C at Week 54	Baseline and Week 54	Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.	Percent of glycosylated hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in FPG at Week 54	Baseline and Week 54	Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 2-Hour PMG at Week 54	Baseline and Week 54	Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.	mg/dL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Sitagliptin 100 mg	-1.09	95% Confidence Interval -1.29 to -0.89	Percentage of glycosylated hemoglobin
Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Pioglitazone 15 mg	-0.88	95% Confidence Interval -1.09 to -0.68	Percentage of glycosylated hemoglobin
Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Pioglitazone 30 mg	-1.21	95% Confidence Interval -1.41 to -1.02	Percentage of glycosylated hemoglobin
Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Pioglitazone 45 mg	-1.20	95% Confidence Interval -1.40 to -1.00	Percentage of glycosylated hemoglobin
Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Sitagliptin 100 mg/ Pioglitazone 15 mg	-1.53	95% Confidence Interval -1.73 to -1.34	Percentage of glycosylated hemoglobin
Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Sitagliptin 100 mg/ Pioglitazone 30 mg	-1.63	95% Confidence Interval -1.82 to -1.43	Percentage of glycosylated hemoglobin
Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Sitagliptin 100 mg/ Pioglitazone 45 mg	-1.81	95% Confidence Interval -2.00 to -1.62	Percentage of glycosylated hemoglobin
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Sitagliptin 100 mg	-24.3	95% Confidence Interval -32.0 to -16.5	mg/dL
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Pioglitazone 15 mg	-19.5	95% Confidence Interval -27.2 to -11.7	mg/dL
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Pioglitazone 30 mg	-29.9	95% Confidence Interval -37.6 to -22.3	mg/dL

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sitagliptin 100 mg	231
Overall Study	STARTED	Pioglitazone 15 mg	230
Overall Study	STARTED	Pioglitazone 30 mg	233
Overall Study	STARTED	Pioglitazone 45 mg	230
Overall Study	STARTED	Sitagliptin 100 mg/ Pioglitazone 15 mg	230
Overall Study	STARTED	Sitagliptin 100 mg/ Pioglitazone 30 mg	231
Overall Study	STARTED	Sitagliptin 100 mg/ Pioglitazone 45 mg	230
Overall Study	COMPLETED	Sitagliptin 100 mg	175
Overall Study	COMPLETED	Pioglitazone 15 mg	158
Overall Study	COMPLETED	Pioglitazone 30 mg	168

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events525

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	Sitagliptin 100 mg	13	231	13
other	Nasopharyngitis	Infections and infestations	Pioglitazone 15 mg	10	230	11
other	Nasopharyngitis	Infections and infestations	Pioglitazone 30 mg	12	233	16
other	Nasopharyngitis	Infections and infestations	Pioglitazone 45 mg	9	230	10
other	Nasopharyngitis	Infections and infestations	Sitagliptin 100 mg/ Pioglitazone 15 mg	12	230	15
other	Nasopharyngitis	Infections and infestations	Sitagliptin 100 mg/ Pioglitazone 30 mg	15	231	19
other	Nasopharyngitis	Infections and infestations	Sitagliptin 100 mg/ Pioglitazone 45 mg	8	230	10
other	Upper respiratory tract infection	Infections and infestations	Sitagliptin 100 mg	10	231	13
other	Upper respiratory tract infection	Infections and infestations	Pioglitazone 15 mg	6	230	6
other	Upper respiratory tract infection	Infections and infestations	Pioglitazone 30 mg	8	233	9

1 to 10 of 525Source ClinicalTrials.gov

See all 525 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sitagliptin 100 mg
Total, all-cause mortality	Pioglitazone 15 mg
Total, all-cause mortality	Pioglitazone 30 mg
Total, all-cause mortality	Pioglitazone 45 mg
Total, all-cause mortality	Sitagliptin 100 mg/ Pioglitazone 15 mg
Total, all-cause mortality	Sitagliptin 100 mg/ Pioglitazone 30 mg
Total, all-cause mortality	Sitagliptin 100 mg/ Pioglitazone 45 mg
Total, other adverse events	Sitagliptin 100 mg	60	231
Total, other adverse events	Pioglitazone 15 mg	41	230
Total, other adverse events	Pioglitazone 30 mg	45	233

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23909985	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00722371

GET https://conductscience.org/api/trials/v1/NCT00722371/results?page=2

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