Type 2 Diabetes Mellitus (T2DM)Phase 4NCT01131182

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

A Phase 4 study testing Sitagliptin phosphate, Comparator: Sulfonylurea and Metformin in people with Type 2 Diabetes Mellitus (T2DM), run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus (T2DM)
What is being tested?: Sitagliptin phosphate, Comparator: Sulfonylurea and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,147 participants
Where: No sites listed yet
Study dates: 13 Jun 2010to 4 Nov 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Muslim men and women with type 2 diabetes
Participants who intend to fast during the month of Ramadan
Participants who have been on a stable dose of sulfonylurea for at least three months

Who cannot join

Participants with type 1 diabetes mellitus
Pregnant or breast feeding women
Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment
Participants on insulin
Participants on any class of oral diabetic therapy other than sulfonylurea or metformin

About this study

Official title: An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting

This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

Read the detailed description

This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Conditions: Type 2 Diabetes Mellitus (T2DM)
Being tested: Sitagliptin phosphate, Comparator: Sulfonylurea, Metformin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sitagliptin phosphateDrug
Also called Januvia
Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.
Comparator: SulfonylureaDrug
Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription
MetforminDrug
Also called Glucophage
Participants could continue pre-study metformin as concomitant therapy during the study.

Study groups in NCT01131182
Study group	Role	What they receive
Sitagliptin	Experimental	Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period. Receives: Drug: Sitagliptin phosphate; Drug: Metformin
Sulfonylurea	Active comparator	Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period. Receives: Drug: Comparator: Sulfonylurea; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
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.
Measured: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)

Secondary outcomes (1)

Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
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.
Measured: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 20104 Nov 2010

First posted26 May 2010 (estimated)
Study start13 Jun 2010
Primary completion4 Nov 2010
Study completion4 Nov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01131182
Sponsor's protocol ID: 0431-263
Other IDs: 2010_538
Status last verified: Aug 2022
First submitted: 25 May 2010
Last updated: 21 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Al Sifri S, Basiounny A, Echtay A, Al Omari M, Harman-Boehm I, Kaddaha G, Al Tayeb K, Mahfouz AS, Al Elq A, Radican L, Ozesen C, Katzeff HL, Musser BJ, Suryawanshi S, Girman CJ, Davies MJ, Engel SS; 2010 Ramadan Study Group. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial. Int J Clin Pract. 2011 Nov;65(11):1132-40. doi: 10.1111/j.1742-1241.2011.02797.x. Epub 2011 Sep 27.
PubMed 21951832
Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
PubMed 37435938

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting
ClinicalTrials.gov ID: NCT01131182
Acronym / sponsor ID: 0431-263
Conditions: Type 2 Diabetes Mellitus (T2DM)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,147 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 13 Jun 2010 (actual)
Primary completion: 4 Nov 2010 (actual)
Study completion: 4 Nov 2010 (actual)
First posted: 26 May 2010 (estimated)
Results: Posted 20 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

Detailed description

This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sitagliptin	Experimental	Drug: Sitagliptin phosphate, Drug: MetforminSitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
Sulfonylurea	Active comparator	Drug: Comparator: Sulfonylurea, Drug: MetforminSulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Muslim men and women with type 2 diabetes
Participants who intend to fast during the month of Ramadan
Participants who have been on a stable dose of sulfonylurea for at least three months

Key exclusion criteria (5 listed)

Participants with type 1 diabetes mellitus
Pregnant or breast feeding women
Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment
Participants on insulin
Participants on any class of oral diabetic therapy other than sulfonylurea or metformin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sitagliptin phosphateAlso: JanuviaSitagliptin 100 mg tablet administered orally once daily over the Ramadan period.	Drug	Sitagliptin
Comparator: SulfonylureaSulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription	Drug	Sulfonylurea
MetforminAlso: GlucophageParticipants could continue pre-study metformin as concomitant therapy during the study.	Drug	Sitagliptin, Sulfonylurea

Primary outcome

Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
Time frame: 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.

1 secondary outcome

Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
Time frame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)

Results and safety

Results posted to the registry on 20 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin	529	513
Sulfonylurea	537	521

Primary outcome: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event

Time frame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10). Number. Unit: proportion of participants

Measure	Sitagliptin n = 507	Sulfonylurea n = 514
Value	0.07	0.13

Sitagliptin vs Sulfonylurea: p = 0.0005, Cochran-Mantel-Haenszel

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	0 of 507 (0%)	34 of 507 (6.7%)	Not reported
Sulfonylurea	3 of 514 (0.6%)	68 of 514 (13.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21951832Al Sifri S, Basiounny A, Echtay A, Al Omari M, Harman-Boehm I, Kaddaha G, Al Tayeb K, Mahfouz AS, Al Elq A, Radican L, Ozesen C, Katzeff HL, Musser BJ, Suryawanshi S, Girman CJ, Davies MJ, Engel SS; 2010 Ramadan Study Group. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial. Int J Clin Pract. 2011 Nov;65(11):1132-40. doi: 10.1111/j.1742-1241.2011.02797.x. Epub 2011 Sep 27.
Derived from this study: PubMed 37435938Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sitagliptin phosphate, Comparator: Sulfonylurea and Metformin in people with Type 2 Diabetes Mellitus (T2DM), run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With at Least One Symptomatic Hypoglycemic Event (time frame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01131182, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.