Trial · NCT01131182

Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

NCT01131182, Phase 4, Completed, Merck Sharp & Dohme LLC; results first posted 2012-01-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263). Trials, record NCT01131182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01131182

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
NCT number: NCT01131182
Status: Completed
Phases: Phase 4
Enrollment: 1,147 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: Sitagliptin phosphate, Comparator: Sulfonylurea, Metformin
First posted: 2010-05-26
Last updated: 2022-09-21
Results first posted: 2012-01-20

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Participants With at Least One Symptomatic Hypoglycemic Event	30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)	Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.
Secondary	Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)	Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.

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	Proportion of Participants With at Least One Symptomatic Hypoglycemic Event	30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)	All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)	All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.	Proportion 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	Value	Units
Proportion of Participants With at Least One Symptomatic Hypoglycemic Event	Sitagliptin	0.07	proportion of participants
Proportion of Participants With at Least One Symptomatic Hypoglycemic Event	Sulfonylurea	0.13	proportion of participants
Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	Sitagliptin	0.08	Proportion of participants
Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	Sulfonylurea	0.18	Proportion of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sitagliptin	529
Overall Study	STARTED	Sulfonylurea	537
Overall Study	COMPLETED	Sitagliptin	513
Overall Study	COMPLETED	Sulfonylurea	521
Overall Study	NOT COMPLETED	Sitagliptin	16
Overall Study	NOT COMPLETED	Sulfonylurea	16

Source ClinicalTrials.gov

Adverse events16

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
other	Hunger	General disorders	Sitagliptin	13	507
other	Hunger	General disorders	Sulfonylurea	35	514
other	Dizziness	Nervous system disorders	Sitagliptin	20	507
other	Dizziness	Nervous system disorders	Sulfonylurea	38	514
other	Headache	Nervous system disorders	Sitagliptin	25	507
other	Headache	Nervous system disorders	Sulfonylurea	44	514
other	Tremor	Nervous system disorders	Sitagliptin	7	507
other	Tremor	Nervous system disorders	Sulfonylurea	34	514
other	Hyperhidrosis	Skin and subcutaneous tissue disorders	Sitagliptin	19	507
other	Hyperhidrosis	Skin and subcutaneous tissue disorders	Sulfonylurea	32	514

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

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
Total, other adverse events	Sitagliptin	34	507
Total, other adverse events	Sulfonylurea	68	514
Total, serious adverse events	Sitagliptin	0	507
Total, serious adverse events	Sulfonylurea	3	514

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21951832	RESULT	PubMed
37435938	DERIVED	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 vs Sulfonylurea: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01131182

GET https://conductscience.org/api/trials/v1/NCT01131182/registered

API reference For AI assistants