Trial · NCT00094770
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
NCT00094770, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024). Trials, record NCT00094770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00094770
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
- NCT number
- NCT00094770
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,172 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- sitagliptin (MK0431), Comparator: glipizide
- First posted
- 2004-10-25
- Last updated
- 2016-08-26
- Results first posted
- 2009-12-22
Source ClinicalTrials.gov
Registered outcomes12
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 52 | Baseline and Week 52 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent. |
| Secondary | Change From Baseline in HbA1c at Week 104 | Baseline and Week 104 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent. |
| Secondary | Change From Baseline in Body Weight at Week 52 | Baseline and Week 52 | Change from baseline at Week 52 is defined as Week 52 minus Week 0. |
| Secondary | Change From Baseline in Body Weight at Week 104 | Baseline and Week 104 | Change from baseline at Week 104 is defined as Week 104 minus Week 0. |
| Secondary | Hypoglycemic Events at Week 52 | Baseline to Week 52 | Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia. |
| Secondary | Hypoglycemic Events at Week 104 | Baseline to Week 104 | Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia. |
| Secondary | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 | Baseline to Week 104 | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. |
| Secondary | Number of Participants With Serious CAEs at Week 104 | Baseline to Week 104 | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. |
| Secondary | Number of Participants With Drug-related CAEs at Week 104 | Baseline to Week 104 | Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs. |
| Secondary | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 | Baseline to Week 104 | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 52 | Baseline and Week 52 | The per protocol population required that a participant had measurements both at baseline and at Week 52, and did not have any major protocol violations (e.g. drug compliance \< 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c at Week 104 | Baseline and Week 104 | The per protocol population required that a participant had measurements both at baseline and at Week 104, and did not have any major protocol violations (e.g. drug compliance \< 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 52 | Baseline and Week 52 | The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed. | Kilograms | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 104 | Baseline and Week 104 | The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed. | Kilograms | LEAST_SQUARES_MEAN |
| SECONDARY | Hypoglycemic Events at Week 52 | Baseline to Week 52 | All randomized participants who received at least 1 dose of the double-blind study therapy. | Participants | NUMBER |
| SECONDARY | Hypoglycemic Events at Week 104 | Baseline to Week 104 | All randomized participants who received at least 1 dose of the double-blind study therapy. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 | Baseline to Week 104 | All randomized participants who received at least 1 dose of the double-blind study therapy. | Participants | NUMBER |
| SECONDARY | Number of Participants With Serious CAEs at Week 104 | Baseline to Week 104 | All randomized participants who received at least 1 dose of the double-blind study therapy. | Participants | NUMBER |
| SECONDARY | Number of Participants With Drug-related CAEs at Week 104 | Baseline to Week 104 | All randomized participants who received at least 1 dose of the double-blind study therapy. | Participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 | Baseline to Week 104 | All randomized participants who received at least 1 dose of the double-blind study therapy. | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in HbA1c at Week 52 | Sitagliptin 100 mg | -0.67 | 95% Confidence Interval -0.75 to -0.59 | Percent | |
| Change From Baseline in HbA1c at Week 52 | Glipizide | -0.67 | 95% Confidence Interval -0.75 to -0.59 | Percent | |
| Change From Baseline in HbA1c at Week 104 | Sitagliptin 100 mg | -0.54 | 95% Confidence Interval -0.64 to -0.45 | Percent | |
| Change From Baseline in HbA1c at Week 104 | Glipizide | -0.51 | 95% Confidence Interval -0.60 to -0.42 | Percent | |
| Change From Baseline in Body Weight at Week 52 | Sitagliptin 100 mg | -1.5 | 95% Confidence Interval -2.0 to -0.9 | Kilograms | |
| Change From Baseline in Body Weight at Week 52 | Glipizide | 1.1 | 95% Confidence Interval 0.5 to 1.6 | Kilograms | |
| Change From Baseline in Body Weight at Week 104 | Sitagliptin 100 mg | -1.6 | 95% Confidence Interval -2.3 to -1.0 | Kilograms | |
| Change From Baseline in Body Weight at Week 104 | Glipizide | 0.7 | 95% Confidence Interval 0.0 to 1.3 | Kilograms | |
| Hypoglycemic Events at Week 52 | Sitagliptin 100 mg | Participants with one or more Hypoglycemic AEs | 29 | Participants | |
| Hypoglycemic Events at Week 52 | Glipizide | Participants with one or more Hypoglycemic AEs | 187 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Year 1 ( Week 0 to Week 52) | STARTED | Sitagliptin 100 mg | 588 | |
| Year 1 ( Week 0 to Week 52) | STARTED | Glipizide | 584 | |
| Year 1 ( Week 0 to Week 52) | COMPLETED | Sitagliptin 100 mg | 386 | |
| Year 1 ( Week 0 to Week 52) | COMPLETED | Glipizide | 412 | |
| Year 1 ( Week 0 to Week 52) | NOT COMPLETED | Sitagliptin 100 mg | 202 | |
| Year 1 ( Week 0 to Week 52) | NOT COMPLETED | Glipizide | 172 | |
| Year 2 (Week 0 to Week 104) | STARTED | Sitagliptin 100 mg | 588 | |
| Year 2 (Week 0 to Week 104) | STARTED | Glipizide | 584 | |
| Year 2 (Week 0 to Week 104) | COMPLETED | Sitagliptin 100 mg | 255 | |
| Year 2 (Week 0 to Week 104) | COMPLETED | Glipizide | 264 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events308
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 | Diarrhoea | Gastrointestinal disorders | Sitagliptin 100 mg | 42 | 588 | |
| other | Diarrhoea | Gastrointestinal disorders | Glipizide | 40 | 584 | |
| other | Bronchitis | Infections and infestations | Sitagliptin 100 mg | 40 | 588 | |
| other | Bronchitis | Infections and infestations | Glipizide | 37 | 584 | |
| other | Influenza | Infections and infestations | Sitagliptin 100 mg | 32 | 588 | |
| other | Influenza | Infections and infestations | Glipizide | 37 | 584 | |
| other | Nasopharyngitis | Infections and infestations | Sitagliptin 100 mg | 71 | 588 | |
| other | Nasopharyngitis | Infections and infestations | Glipizide | 61 | 584 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Sitagliptin 100 mg | 73 | 588 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Glipizide | 79 | 584 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin 100 mg | ||
| Total, all-cause mortality | Glipizide | ||
| Total, other adverse events | Sitagliptin 100 mg | 318 | 588 |
| Total, other adverse events | Glipizide | 374 | 584 |
| Total, serious adverse events | Sitagliptin 100 mg | 64 | 588 |
| Total, serious adverse events | Glipizide | 73 | 584 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sitagliptin 100 mg vs Glipizide: Number of Participants With Drug-related LAEs at Week 104 | Trial comparisons |
| Sitagliptin 100 mg vs Glipizide: serious adverse events | Trial comparisons |
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.
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/NCT00094770
GET https://conductscience.org/api/trials/v1/NCT00094770/results?page=2