Trial · NCT00411554

A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

NCT00411554, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-09-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED). Trials, record NCT00411554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00411554

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Trial

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

Title: A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
NCT number: NCT00411554
Status: Completed
Phases: Phase 3
Enrollment: 319 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Interventions: sitagliptin phosphate, Comparator: voglibose
First posted: 2006-12-14
Last updated: 2016-02-05
Results first posted: 2009-09-25

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in HbA1c at Week 12	Baseline and Week 12	HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 12	Baseline and Week 12	Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.
Secondary	Change From Baseline in 2 Hour Postprandial Glucose at Week 12	Baseline and Week 12	Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.

Source ClinicalTrials.gov

Outcomes3

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 HbA1c at Week 12	Baseline and Week 12	The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for major protocol violations.	Percent	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose at Week 12	Baseline and Week 12	The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 2 Hour Postprandial Glucose at Week 12	Baseline and Week 12	The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.	mg/dL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Change From Baseline in HbA1c at Week 12	Sitagliptin 50 mg QD	-0.70	95% Confidence Interval -0.78 to -0.62	Percent
Change From Baseline in HbA1c at Week 12	Voglibose 0.2 mg TID	-0.30	95% Confidence Interval -0.39 to -0.22	Percent
Change From Baseline in Fasting Plasma Glucose at Week 12	Sitagliptin 50 mg QD	-19.6	95% Confidence Interval -22.8 to -16.4	mg/dL
Change From Baseline in Fasting Plasma Glucose at Week 12	Voglibose 0.2 mg TID	-8.9	95% Confidence Interval -12.2 to -5.5	mg/dL
Change From Baseline in 2 Hour Postprandial Glucose at Week 12	Sitagliptin 50 mg QD	-51.0	95% Confidence Interval -56.5 to -45.4	mg/dL
Change From Baseline in 2 Hour Postprandial Glucose at Week 12	Voglibose 0.2 mg TID	-32.2	95% Confidence Interval -37.9 to -26.5	mg/dL

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Sitagliptin 50 mg QD	163
Overall Study	STARTED	Voglibose 0.2 mg TID	156
Overall Study	COMPLETED	Sitagliptin 50 mg QD	155
Overall Study	COMPLETED	Voglibose 0.2 mg TID	147
Overall Study	NOT COMPLETED	Sitagliptin 50 mg QD	8
Overall Study	NOT COMPLETED	Voglibose 0.2 mg TID	9

Source ClinicalTrials.gov

Adverse events16

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
other	Abdominal distension	Gastrointestinal disorders	Sitagliptin 50 mg QD	7	163
other	Abdominal distension	Gastrointestinal disorders	Voglibose 0.2 mg TID	14	156
other	Diarrhoea	Gastrointestinal disorders	Sitagliptin 50 mg QD	4	163
other	Diarrhoea	Gastrointestinal disorders	Voglibose 0.2 mg TID	12	156
other	Flatulence	Gastrointestinal disorders	Sitagliptin 50 mg QD	7	163
other	Flatulence	Gastrointestinal disorders	Voglibose 0.2 mg TID	17	156
other	Nasopharyngitis	Infections and infestations	Sitagliptin 50 mg QD	22	163
other	Nasopharyngitis	Infections and infestations	Voglibose 0.2 mg TID	24	156
other	Alanine aminotransferase increased	Investigations	Sitagliptin 50 mg QD	1	163
other	Alanine aminotransferase increased	Investigations	Voglibose 0.2 mg TID	11	155

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Sitagliptin 50 mg QD
Total, all-cause mortality	Voglibose 0.2 mg TID
Total, other adverse events	Sitagliptin 50 mg QD	32
Total, other adverse events	Voglibose 0.2 mg TID	62
Total, serious adverse events	Sitagliptin 50 mg QD	1
Total, serious adverse events	Voglibose 0.2 mg TID	2

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20590736	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/NCT00411554

GET https://conductscience.org/api/trials/v1/NCT00411554/registered

API reference For AI assistants