Trial · NCT02738879
Randomized Sitagliptin Withdrawal Study (MK-0431-845)
NCT02738879, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Sitagliptin Withdrawal Study (MK-0431-845). Trials, record NCT02738879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02738879
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Sitagliptin Withdrawal Study (MK-0431-845)
- NCT number
- NCT02738879
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 746 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin, Placebo to sitagliptin, Metformin, Metformin XR, Insulin glargine
- First posted
- 2016-04-14
- Last updated
- 2019-02-25
- Other registries' IDs
- eudract:2015-004990-34
- Results first posted
- 2019-02-25
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in A1C at Week 30 | Baseline and Week 30 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C. |
| Primary | Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Up to 30 weeks | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. |
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 30 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Primary | Percentage of Participants Who Experienced One or More Adverse Events (AEs) | Up to 32 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Secondary | Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Up to 30 weeks | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined. |
| Secondary | Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 | Baseline and Week 30 | Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline. |
| Secondary | Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Up to 30 weeks | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. |
| Secondary | Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Up to 30 weeks | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. |
| Secondary | Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Up to 30 weeks | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). |
| Secondary | Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30 | Week 30 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 at Week 30 | Baseline and Week 30 | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). | Percent A1C | LEAST_SQUARES_MEAN |
| PRIMARY | Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Up to 30 weeks | All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race). | Events/Participant-Years | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 30 weeks | All randomized participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Up to 30 weeks | All randomized participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 | Baseline and Week 30 | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). | Insulin Units | LEAST_SQUARES_MEAN |
| SECONDARY | Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Up to 30 weeks | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race). | Events/Participant-Years | NUMBER |
| SECONDARY | Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Up to 30 weeks | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race). | Events/Participant-Years | NUMBER |
| SECONDARY | Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Up to 30 weeks | All randomized participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30 | Week 30 | All randomized participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Baseline and Week 30 | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). | mg/dL | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
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 at Week 30 | Sitagliptin | -1.88 | 95% Confidence Interval -1.98 | Percent A1C | |
| Change From Baseline in A1C at Week 30 | Placebo | -1.42 | 95% Confidence Interval -1.52 | Percent A1C | |
| Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Sitagliptin | 1.55 | 95% Confidence Interval 1.22 | Events/Participant-Years | |
| Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Placebo | 2.12 | 95% Confidence Interval 1.70 | Events/Participant-Years | |
| Percentage of Participants Who Discontinued Study Drug Due to an AE | Sitagliptin | 1.3 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an AE | Placebo | 1.6 | Percentage of participants | ||
| Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Sitagliptin | 33.5 | 95% Confidence Interval 28.5 | Percentage of participants | |
| Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Placebo | 37.7 | 95% Confidence Interval 32.7 | Percentage of participants | |
| Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 | Sitagliptin | 53.2 | 95% Confidence Interval 48.5 | Insulin Units | |
| Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 | Placebo | 61.3 | 95% Confidence Interval 56.5 | Insulin Units |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin | 374 | |
| Overall Study | STARTED | Placebo | 372 | |
| Overall Study | Treated | Sitagliptin | 373 | |
| Overall Study | Treated | Placebo | 370 | |
| Overall Study | COMPLETED | Sitagliptin | 361 | |
| Overall Study | COMPLETED | Placebo | 347 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 25 |
Source ClinicalTrials.gov
Adverse events70
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 | 24 | 373 | 30 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 32 | 370 | 35 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sitagliptin | 35 | 373 | 96 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo | 24 | 370 | 74 |
| other | Headache | Nervous system disorders | Sitagliptin | 25 | 373 | 36 |
| other | Headache | Nervous system disorders | Placebo | 19 | 370 | 23 |
| serious | Acute myocardial infarction | Cardiac disorders | Sitagliptin | 1 | 373 | 1 |
| serious | Acute myocardial infarction | Cardiac disorders | Placebo | 1 | 370 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Sitagliptin | 1 | 373 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 370 | 0 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin | 0 | 373 |
| Total, all-cause mortality | Placebo | 2 | 370 |
| Total, other adverse events | Sitagliptin | 79 | 373 |
| Total, other adverse events | Placebo | 72 | 370 |
| Total, serious adverse events | Sitagliptin | 14 | 373 |
| Total, serious adverse events | Placebo | 18 | 370 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30393950 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sitagliptin vs Placebo: deaths from any cause | 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/NCT02738879
GET https://conductscience.org/api/trials/v1/NCT02738879/results?page=2