Type 2 Diabetes MellitusPhase 3NCT01340768

Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

A Phase 3 study testing Sitagliptin, Sulfonylurea and Metformin in people with Type 2 Diabetes Mellitus, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Sitagliptin, Sulfonylurea and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 870 participants
Where: No sites listed yet
Study dates: 22 Jun 2010to 21 Sep 2011
Phase: Phase 3
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, with type 2 diabetes mellitus
Intends to fast during the month of Ramadan
Hemoglobin A1c (HbA1c) ≤10% at screening
On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose

Who cannot join

Type 1 diabetes mellitus
Pregnant or breast feeding or with gestational diabetes
Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)
Any use of insulin (prior to or during Ramadan)
Use of any class of oral antidiabetic therapy other than an SU or metformin
Current participation in another interventional study

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 is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.

Read the detailed description

This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Conditions: Type 2 Diabetes Mellitus
Being tested: Sitagliptin, Sulfonylurea, Metformin
Keywords: Glucose metabolism disorders Metabolic diseases Peptidase inhibitors
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.

SitagliptinDrug
Also called Sitagliptin phosphate, MK-0431, JANUVIA®
One 100 mg tablet taken orally once daily
SulfonylureaDrug
Also called Amaryl (glimepiride)
Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.
MetforminDrug
Also called Glucophage
Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.

Study groups in NCT01340768
Study group	Role	What they receive
Sitagliptin	Experimental	Sitagliptin 100mg taken orally once daily with or without metformin Receives: Drug: Sitagliptin; Drug: Metformin
Sulfonylurea Therapy	Active comparator	Usual sulfonylurea therapy with or without metformin Receives: Drug: Sulfonylurea; Drug: Metformin

What is being measured

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

Percentage of Participants With at Least One Symptomatic Hypoglycemic Event
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).
Measured: Up to 30 days (Day 1 through last day of Ramadan)

Secondary outcomes (1)

Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
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.
Measured: Up to 30 days (Day 1 through last day of Ramadan)

Timeline

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

22 Jun 201021 Sep 2011

First posted25 Apr 2011 (estimated)
Study start22 Jun 2010
Primary completion21 Sep 2011
Study completion21 Sep 2011

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 MellitusStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 870 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340768
Sponsor's protocol ID: 0431-262
Other IDs: CTRI/2011/06/001838
Status last verified: May 2017
First submitted: 24 Mar 2011
Last updated: 5 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

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
Aravind SR, Ismail SB, Balamurugan R, Gupta JB, Wadhwa T, Loh SM, Suryawanshi S, Davies MJ, Girman CJ, Katzeff HL, Radican L, Engel SS, Wolthers T. Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study. Curr Med Res Opin. 2012 Aug;28(8):1289-96. doi: 10.1185/03007995.2012.707119. Epub 2012 Jul 6.
PubMed 22738801

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 5 Jun 2017. 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: NCT01340768
Acronym / sponsor ID: 0431-262
Conditions: Type 2 Diabetes Mellitus
Keywords: Glucose metabolism disorders Metabolic diseases Peptidase inhibitors
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 870 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 22 Jun 2010 (actual)
Primary completion: 21 Sep 2011 (actual)
Study completion: 21 Sep 2011 (actual)
First posted: 25 Apr 2011 (estimated)
Results: Posted 8 Oct 2012

Clinical summary

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

Detailed description

This study and NCT01131182 (MK-0431-263) 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, Drug: MetforminSitagliptin 100mg taken orally once daily with or without metformin
Sulfonylurea Therapy	Active comparator	Drug: Sulfonylurea, Drug: MetforminUsual sulfonylurea therapy with or without metformin

Who may qualify

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

Key inclusion criteria (4 listed)

Muslim, with type 2 diabetes mellitus
Intends to fast during the month of Ramadan
Hemoglobin A1c (HbA1c) ≤10% at screening
On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose

Key exclusion criteria (8 listed)

Type 1 diabetes mellitus
Pregnant or breast feeding or with gestational diabetes
Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)

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
SitagliptinAlso: Sitagliptin phosphate, MK-0431, JANUVIA®One 100 mg tablet taken orally once daily	Drug	Sitagliptin
SulfonylureaAlso: Amaryl (glimepiride)Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.	Drug	Sulfonylurea Therapy
MetforminAlso: GlucophageParticipants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.	Drug	Sitagliptin, Sulfonylurea Therapy

Primary outcome

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

1 secondary outcome

Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
Time frame: Up to 30 days (Day 1 through last day of Ramadan)

Results and safety

Results posted to the registry on 8 Oct 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	436	419
Sulfonylurea Therapy	434	429

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

Time frame: Up to 30 days (Day 1 through last day of Ramadan). Number. Unit: percentage of participants

Measure	Sitagliptin n = 421	Sulfonylurea Therapy n = 427
Value	3.8	7.3

Sitagliptin vs Sulfonylurea Therapy: Risk Ratio (RR): 0.52 (95% CI 0.29 to 0.94), p = 0.028, Cochran-Mantel-Haenszel

Population analysed: All participants as treated population defined as all randomized participants who received at least one dose of study drug.

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	1 of 421 (0.2%)	16 of 421 (3.8%)	Not reported
Sulfonylurea Therapy	0 of 427 (0%)	33 of 427 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Derived from this study: PubMed 22738801Aravind SR, Ismail SB, Balamurugan R, Gupta JB, Wadhwa T, Loh SM, Suryawanshi S, Davies MJ, Girman CJ, Katzeff HL, Radican L, Engel SS, Wolthers T. Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study. Curr Med Res Opin. 2012 Aug;28(8):1289-96. doi: 10.1185/03007995.2012.707119. Epub 2012 Jul 6.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sitagliptin, Sulfonylurea and Metformin in people with Type 2 Diabetes Mellitus, 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 4 inclusion and 8 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 5 Jun 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 Oct 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?

Percentage of Participants With at Least One Symptomatic Hypoglycemic Event (time frame: Up to 30 days (Day 1 through last day of Ramadan)). 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 NCT01340768, 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 5 Jun 2017.