Trial · NCT01590771
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
NCT01590771, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2015-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253). Trials, record NCT01590771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01590771
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
- NCT number
- NCT01590771
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 498 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin, Placebo, Gliclazide, Glimepiride, Metformin
- First posted
- 2012-05-03
- Last updated
- 2018-08-17
- Results first posted
- 2015-05-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Baseline and Week 24 | A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0. |
| Primary | Number of Participants Who Experienced an Adverse Event | Up to 26 weeks | An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions. |
| Primary | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 24 weeks | An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions. |
| Secondary | Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Baseline and Week 24 | This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0. |
| Secondary | Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Baseline and Week 24 | This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0. |
| Secondary | Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin | Baseline and Week 24 | A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0. |
| Secondary | Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone | Baseline and Week 24 | A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0. |
| Secondary | Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin | Baseline and Week 24 | This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0. |
| Secondary | Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone | Baseline and Week 24 | This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0. |
| Secondary | Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin | Baseline and Week 24 | This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Baseline and Week 24 | Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | Percent of glycosylated hemoglobin (A1C) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Baseline and Week 24 | Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Baseline and Week 24 | Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin | Baseline and Week 24 | Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | Percent of glycosylated hemoglobin (A1C) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone | Baseline and Week 24 | Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | Percent of glycosylated hemoglobin (A1C) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin | Baseline and Week 24 | Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone | Baseline and Week 24 | Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin | Baseline and Week 24 | Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone | Baseline and Week 24 | Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement. | mg/dL | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants Who Experienced an Adverse Event | Up to 26 weeks | All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received. | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
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 A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Sitagliptin | -0.88 | 95% Confidence Interval -0.99 to -0.76 | Percent of glycosylated hemoglobin (A1C) | |
| Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Placebo | -0.27 | 95% Confidence Interval -0.38 to -0.15 | Percent of glycosylated hemoglobin (A1C) | |
| Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Sitagliptin | -40.7 | 95% Confidence Interval -49.4 to -31.9 | mg/dL | |
| Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Placebo | -7.7 | 95% Confidence Interval -16.6 to 1.2 | mg/dL | |
| Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Sitagliptin | -24.4 | 95% Confidence Interval -29.1 | mg/dL | |
| Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin | Placebo | -7.7 | 95% Confidence Interval -12.3 to -3.0 | mg/dL | |
| Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin | Sitagliptin | -0.86 | 95% Confidence Interval -1.01 to -0.71 | Percent of glycosylated hemoglobin (A1C) | |
| Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin | Placebo | -0.45 | 95% Confidence Interval -0.60 to -0.30 | Percent of glycosylated hemoglobin (A1C) | |
| Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone | Sitagliptin | -0.85 | 95% Confidence Interval -1.04 to -0.67 | Percent of glycosylated hemoglobin (A1C) | |
| Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone | Placebo | -0.05 | 95% Confidence Interval -0.24 to 0.14 | Percent of glycosylated hemoglobin (A1C) |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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 | 249 | |
| Overall Study | STARTED | Placebo | 249 | |
| Overall Study | COMPLETED | Sitagliptin | 230 | |
| Overall Study | COMPLETED | Placebo | 210 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 39 |
Source ClinicalTrials.gov
Adverse events34
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 | Urinary tract infection | Infections and infestations | Sitagliptin | 14 | 248 | 14 |
| other | Urinary tract infection | Infections and infestations | Placebo | 11 | 249 | 11 |
| other | Hyperlipidaemia | Metabolism and nutrition disorders | Sitagliptin | 8 | 248 | 8 |
| other | Hyperlipidaemia | Metabolism and nutrition disorders | Placebo | 15 | 249 | 15 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sitagliptin | 35 | 248 | 76 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo | 17 | 249 | 28 |
| serious | Angina pectoris | Cardiac disorders | Sitagliptin | 1 | 248 | 1 |
| serious | Angina pectoris | Cardiac disorders | Placebo | 0 | 249 | 0 |
| serious | Erysipelas | Infections and infestations | Sitagliptin | 1 | 248 | 1 |
| serious | Erysipelas | Infections and infestations | Placebo | 0 | 249 | 0 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 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 | Placebo | ||
| Total, other adverse events | Sitagliptin | 54 | 248 |
| Total, other adverse events | Placebo | 40 | 249 |
| Total, serious adverse events | Sitagliptin | 7 | 248 |
| Total, serious adverse events | Placebo | 7 | 249 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27502307 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sitagliptin vs Placebo: Number of Participants Who Experienced an Adverse Event | Trial comparisons |
| Sitagliptin vs Placebo: Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Trial comparisons |
| Sitagliptin vs Placebo: 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/NCT01590771
GET https://conductscience.org/api/trials/v1/NCT01590771/results?page=2