Trial · NCT00701090
A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
NCT00701090, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-10-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED). Trials, record NCT00701090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00701090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
- NCT number
- NCT00701090
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,035 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus, Non Insulin Dependent, Diabetes Mellitus, Non-Insulin-Dependent
- Interventions
- sitagliptin, Comparator: glimepiride, open-label metformin
- First posted
- 2008-06-19
- Last updated
- 2017-03-10
- Results first posted
- 2010-10-05
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 HbA1c at Week 30 | Week 0 to Week 30 | Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent. |
| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 | Week 0 to Week 30 | Change from baseline at Week 30 was defined as Week 30 minus Week 0. |
| Secondary | Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 | Week 0 to Week 30 | |
| Secondary | Change From Baseline in Body Weight at Week 30 | Week 0 to Week 30 | Change from baseline at Week 30 was defined as Week 30 minus Week 0. |
| Secondary | Percent of Patients With A1C <7.0% at Week 30 | Week 30 | |
| Secondary | Percent of Patients With A1C <6.5% at Week 30 | Week 30 |
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 HbA1c at Week 30 | Week 0 to Week 30 | The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance \<85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication). | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 | Week 0 to Week 30 | The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance \<85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 | Week 0 to Week 30 | All patients who took at least one dose of study therapy. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Body Weight at Week 30 | Week 0 to Week 30 | All patients who took at least one dose of study therapy and had body weight measurements at both baseline and Week 30. | Kilograms | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Patients With A1C <7.0% at Week 30 | Week 30 | The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance \<85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication). | Percentage of Participants | NUMBER |
| SECONDARY | Percent of Patients With A1C <6.5% at Week 30 | Week 30 | The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance \<85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication). | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
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 30 | Sitagliptin | -0.47 | 95% Confidence Interval -0.55 to -0.39 | Percent | |
| Change From Baseline in HbA1c at Week 30 | Glimepiride | -0.54 | 95% Confidence Interval -0.62 to -0.45 | Percent | |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 | Sitagliptin | -14.6 | 95% Confidence Interval -17.9 to -11.2 | mg/dL | |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 | Glimepiride | -17.5 | 95% Confidence Interval -20.8 to -14.1 | mg/dL | |
| Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 | Sitagliptin | 7.0 | Percentage of Participants | ||
| Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 | Glimepiride | 22.0 | Percentage of Participants | ||
| Change From Baseline in Body Weight at Week 30 | Sitagliptin | -0.8 | 95% Confidence Interval -1.1 to -0.5 | Kilograms | |
| Change From Baseline in Body Weight at Week 30 | Glimepiride | 1.2 | 95% Confidence Interval 0.9 to 1.5 | Kilograms | |
| Percent of Patients With A1C <7.0% at Week 30 | Sitagliptin | 52.4 | Percentage of Participants | ||
| Percent of Patients With A1C <7.0% at Week 30 | Glimepiride | 59.6 | Percentage of Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin | 516 | |
| Overall Study | STARTED | Glimepiride | 519 | |
| Overall Study | COMPLETED | Sitagliptin | 468 | |
| Overall Study | COMPLETED | Glimepiride | 468 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 48 | |
| Overall Study | NOT COMPLETED | Glimepiride | 51 |
Source ClinicalTrials.gov
Adverse events60
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 | 25 | 519 | |
| other | Nasopharyngitis | Infections and infestations | Glimepiride | 36 | 518 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sitagliptin | 36 | 519 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Glimepiride | 114 | 518 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Sitagliptin | 1 | 516 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Glimepiride | 0 | 518 | |
| serious | Acute coronary syndrome | Cardiac disorders | Sitagliptin | 0 | 516 | |
| serious | Acute coronary syndrome | Cardiac disorders | Glimepiride | 1 | 518 | |
| serious | Coronary artery disease | Cardiac disorders | Sitagliptin | 0 | 516 | |
| serious | Coronary artery disease | Cardiac disorders | Glimepiride | 1 | 518 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin | ||
| Total, all-cause mortality | Glimepiride | ||
| Total, other adverse events | Sitagliptin | 58 | 519 |
| Total, other adverse events | Glimepiride | 134 | 518 |
| Total, serious adverse events | Sitagliptin | 16 | 516 |
| Total, serious adverse events | Glimepiride | 11 | 518 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sitagliptin vs Glimepiride: serious adverse events |
Source 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/NCT00701090
GET https://conductscience.org/api/trials/v1/NCT00701090/events?page=2