Trial · NCT01296412
Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
NCT01296412, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2013-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403). Trials, record NCT01296412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01296412
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
- NCT number
- NCT01296412
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 653 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- sitagliptin, liraglutide, glimepiride, metformin
- First posted
- 2011-02-15
- Last updated
- 2017-06-09
- Results first posted
- 2013-03-15
Source ClinicalTrials.gov
Registered outcomes4
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) | Baseline and Week 26 | A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline and Week 26 | Change from baseline at Week 26 is defined as Week 26 minus Week 0. |
| Secondary | Percentage of Participants Reaching A1C Goal of <7.0% | Week 26 | |
| Secondary | Percentage of Participants Reaching A1C Goal of <6.5% | Week 26 |
Source ClinicalTrials.gov
Outcomes4
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) | Baseline and Week 26 | Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations. | percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline and Week 26 | Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Reaching A1C Goal of <7.0% | Week 26 | Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reaching A1C Goal of <6.5% | Week 26 | Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
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 Hemoglobin A1c (A1C) | Sitagliptin +/- Glimepiride | -1.32 | 95% Confidence Interval 1.06 | percent | |
| Change From Baseline in Hemoglobin A1c (A1C) | Liraglutide | -1.42 | 95% Confidence Interval 1.04 | percent | |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Sitagliptin +/- Glimepiride | -33.7 | 95% Confidence Interval 46.2 | mg/dL | |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Liraglutide | -39.6 | 95% Confidence Interval 40.3 | mg/dL | |
| Percentage of Participants Reaching A1C Goal of <7.0% | Sitagliptin +/- Glimepiride | 62.8 | percentage of participants | ||
| Percentage of Participants Reaching A1C Goal of <7.0% | Liraglutide | 72.3 | percentage of participants | ||
| Percentage of Participants Reaching A1C Goal of <6.5% | Sitagliptin +/- Glimepiride | 33.8 | percentage of participants | ||
| Percentage of Participants Reaching A1C Goal of <6.5% | Liraglutide | 38.3 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin +/- Glimepiride | 326 | |
| Overall Study | STARTED | Liraglutide | 327 | |
| Overall Study | COMPLETED | Sitagliptin +/- Glimepiride | 275 | |
| Overall Study | COMPLETED | Liraglutide | 257 | |
| Overall Study | NOT COMPLETED | Sitagliptin +/- Glimepiride | 51 | |
| Overall Study | NOT COMPLETED | Liraglutide | 70 |
Source ClinicalTrials.gov
Adverse events80
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 +/- Glimepiride | 7 | 326 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Liraglutide | 35 | 324 | 42 |
| other | Nausea | Gastrointestinal disorders | Sitagliptin +/- Glimepiride | 10 | 326 | 13 |
| other | Nausea | Gastrointestinal disorders | Liraglutide | 63 | 324 | 73 |
| other | Vomiting | Gastrointestinal disorders | Sitagliptin +/- Glimepiride | 6 | 326 | 10 |
| other | Vomiting | Gastrointestinal disorders | Liraglutide | 21 | 324 | 25 |
| other | Decreased appetite | Metabolism and nutrition disorders | Sitagliptin +/- Glimepiride | 4 | 326 | 4 |
| other | Decreased appetite | Metabolism and nutrition disorders | Liraglutide | 21 | 324 | 21 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sitagliptin +/- Glimepiride | 41 | 326 | 89 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Liraglutide | 15 | 324 | 31 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin +/- Glimepiride | ||
| Total, all-cause mortality | Liraglutide | ||
| Total, other adverse events | Sitagliptin +/- Glimepiride | 58 | 326 |
| Total, other adverse events | Liraglutide | 97 | 324 |
| Total, serious adverse events | Sitagliptin +/- Glimepiride | 17 | 326 |
| Total, serious adverse events | Liraglutide | 12 | 324 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23604551 | DERIVED |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sitagliptin +/- Glimepiride vs Liraglutide: 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/NCT01296412
GET https://conductscience.org/api/trials/v1/NCT01296412/events?page=2