Trial · NCT01340768
Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)
NCT01340768, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2012-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262). Trials, record NCT01340768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01340768
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)
- NCT number
- NCT01340768
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 870 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin, Sulfonylurea, Metformin
- First posted
- 2011-04-25
- Last updated
- 2017-06-05
- Results first posted
- 2012-10-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Symptomatic Hypoglycemic Event | Up to 30 days (Day 1 through last day of Ramadan) | Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). |
| Secondary | Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | Up to 30 days (Day 1 through last day of Ramadan) | Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least One Symptomatic Hypoglycemic Event | Up to 30 days (Day 1 through last day of Ramadan) | All participants as treated population defined as all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | Up to 30 days (Day 1 through last day of Ramadan) | All participants as treated population defined as all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With at Least One Symptomatic Hypoglycemic Event | Sitagliptin | 3.8 | percentage of participants | ||
| Percentage of Participants With at Least One Symptomatic Hypoglycemic Event | Sulfonylurea Therapy | 7.3 | percentage of participants | ||
| Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | Sitagliptin | 4.8 | percentage of participants | ||
| Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | Sulfonylurea Therapy | 9.6 | 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 | 436 | |
| Overall Study | STARTED | Sulfonylurea Therapy | 434 | |
| Overall Study | COMPLETED | Sitagliptin | 419 | |
| Overall Study | COMPLETED | Sulfonylurea Therapy | 429 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 17 | |
| Overall Study | NOT COMPLETED | Sulfonylurea Therapy | 5 |
Source ClinicalTrials.gov
Adverse events4
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 | Hypoglycemia | Metabolism and nutrition disorders | Sitagliptin | 16 | 421 | 19 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Sulfonylurea Therapy | 33 | 427 | 63 |
| serious | Road traffic accident | Injury, poisoning and procedural complications | Sitagliptin | 1 | 421 | 1 |
| serious | Road traffic accident | Injury, poisoning and procedural complications | Sulfonylurea Therapy | 0 | 427 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin | ||
| Total, all-cause mortality | Sulfonylurea Therapy | ||
| Total, other adverse events | Sitagliptin | 16 | 421 |
| Total, other adverse events | Sulfonylurea Therapy | 33 | 427 |
| Total, serious adverse events | Sitagliptin | 1 | 421 |
| Total, serious adverse events | Sulfonylurea Therapy | 0 | 427 |
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 Sulfonylurea Therapy: 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/NCT01340768
GET https://conductscience.org/api/trials/v1/NCT01340768/registered