Trial · NCT01189890
Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
NCT01189890, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2013-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251). Trials, record NCT01189890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01189890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
- NCT number
- NCT01189890
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 480 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- sitagliptin phosphate, Glimepiride, Placebo to Sitagliptin, Placebo to Glimepiride
- First posted
- 2010-08-27
- Last updated
- 2017-06-05
- Results first posted
- 2013-06-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 | Baseline and Week 30 | Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. |
| Primary | Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 | Up to Week 30 | Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms. |
| Primary | Number of Participants Experiencing An Adverse Event (AE) | Up to Week 30 | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. |
| Primary | Number of Participants Discontinuing Study Treatment Due to An AE | Up to Week 30 | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. |
| Secondary | LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Baseline and Week 30 | Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG. |
| Secondary | Percentage of Participants With HbA1c <7.0% at Week 30 | Week 30 | Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c \<7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. |
| Secondary | Percentage of Participants With HbA1c <6.5% at Week 30 | Week 30 | Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c \<6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. |
| Secondary | LS Mean Change From Baseline in Participant Body Weight at Week 30 | Baseline and Week 30 | Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 | Baseline and Week 30 | The population included all randomized participants who had a baseline HbA1c, had a HbA1c at Week 30, did not take prohibited concomitant medications, had compliance \>85%, and did not receive any incorrect study medication. | Percentage of HbA1c | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 | Up to Week 30 | All randomized participants who received at least one dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants Experiencing An Adverse Event (AE) | Up to Week 30 | All randomized participants who received at least one dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants Discontinuing Study Treatment Due to An AE | Up to Week 30 | All randomized participants who received at least one dose of study treatment. | Participants | NUMBER |
| SECONDARY | LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Baseline and Week 30 | The population included all randomized participants who had a FPG value at baseline and Week 30, did not take prohibited concomitant medications, had compliance \>85%, and did not receive any incorrect study medication. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HbA1c <7.0% at Week 30 | Week 30 | The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance \>85%, and did not receive any incorrect study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c <6.5% at Week 30 | Week 30 | The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance \>85%, and did not receive any incorrect study medication. | Percentage of Participants | NUMBER |
| SECONDARY | LS Mean Change From Baseline in Participant Body Weight at Week 30 | Baseline and Week 30 | All randomized participants who received at least one dose of study treatment and had body weight measurements at baseline and at Week 30. | kg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 | Sitagliptin | -0.32 | 95% Confidence Interval 0.78 | Percentage of HbA1c | |
| Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 | Glimepiride | -0.51 | 95% Confidence Interval 0.89 | Percentage of HbA1c | |
| Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 | Sitagliptin | 2 | Participants | ||
| Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 | Glimepiride | 11 | Participants | ||
| Number of Participants Experiencing An Adverse Event (AE) | Sitagliptin | 118 | Participants | ||
| Number of Participants Experiencing An Adverse Event (AE) | Glimepiride | 115 | Participants | ||
| Number of Participants Discontinuing Study Treatment Due to An AE | Sitagliptin | 3 | Participants | ||
| Number of Participants Discontinuing Study Treatment Due to An AE | Glimepiride | 4 | Participants | ||
| LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Sitagliptin | -14.5 | 95% Confidence Interval 39.0 | mg/dL | |
| LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Glimepiride | -21.2 | 95% Confidence Interval 39.1 | mg/dL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 | 241 | |
| Overall Study | STARTED | Glimepiride | 239 | |
| Overall Study | COMPLETED | Sitagliptin | 204 | |
| Overall Study | COMPLETED | Glimepiride | 200 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 37 | |
| Overall Study | NOT COMPLETED | Glimepiride | 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 | Nasopharyngitis | Infections and infestations | Sitagliptin | 18 | 241 | 20 |
| other | Nasopharyngitis | Infections and infestations | Glimepiride | 19 | 236 | 21 |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Sitagliptin | 14 | 241 | 17 |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Glimepiride | 9 | 236 | 15 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sitagliptin | 3 | 241 | 3 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Glimepiride | 15 | 236 | 45 |
| serious | Anaemia | Blood and lymphatic system disorders | Sitagliptin | 0 | 241 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Glimepiride | 1 | 236 | 1 |
| serious | Angina Unstable | Cardiac disorders | Sitagliptin | 0 | 241 | 0 |
| serious | Angina Unstable | Cardiac disorders | Glimepiride | 1 | 236 | 1 |
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 | Glimepiride | ||
| Total, other adverse events | Sitagliptin | 34 | 241 |
| Total, other adverse events | Glimepiride | 40 | 236 |
| Total, serious adverse events | Sitagliptin | 7 | 241 |
| Total, serious adverse events | Glimepiride | 6 | 236 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26041585 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sitagliptin vs Glimepiride: Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 | Trial comparisons |
| Sitagliptin vs Glimepiride: Number of Participants Experiencing An Adverse Event (AE) | Trial comparisons |
| Sitagliptin vs Glimepiride: Number of Participants Discontinuing Study Treatment Due to An AE | Trial comparisons |
| Sitagliptin vs Glimepiride: 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/NCT01189890
GET https://conductscience.org/api/trials/v1/NCT01189890/events?page=2