Type 2 Diabetes MellitusPhase 4NCT02318693

Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)

A Phase 4 study testing Sitagliptin and Glibenclamide 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 20 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Sitagliptin and Glibenclamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: No sites listed yet
Study dates: 4 Feb 2015to 15 Dec 2015
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 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese participants with a diagnosis of Type 2 diabetes mellitus

Who cannot join

History of Type 1 diabetes mellitus or ketoacidosis
History of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation

About this study

Official title: A Randomized, Open-label, Comparative Clinical Trial to Study the Efficacy of Sitagliptin and Glibenclamide in a Short Term Treatment on the Daily Glucose Variability Using Continuous Glucose Monitoring (CGM) in Japanese Patients With Type 2 Diabetes Mellitus

This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM) after 13 days of treatment.

Conditions: Type 2 Diabetes Mellitus
Being tested: Sitagliptin, Glibenclamide
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 MK-0431
Sitagliptin 50 mg orally once a day before breakfast for 14 days
GlibenclamideDrug
Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days

Study groups in NCT02318693
Study group	Role	What they receive
Sitagliptin 50 mg	Experimental	Sitagliptin 50 mg administered orally once daily before breakfast for 14 days. Receives: Drug: Sitagliptin
Glibenclamide 2.50 mg TDD	Active comparator	Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose. Receives: Drug: Glibenclamide

What is being measured

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

Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13
MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.
Measured: Baseline (Day -2) and Day 13

Secondary outcomes (4)

Change From Baseline in the Standard Deviation of Blood Glucose Levels
SD is a popular metric for assessment of postprandial glucose swings. The SD of all glycemic excursions over 24 hours (i.e., total of 288 glucose values over 24 hours) was determined for Baseline and Day 13. Original values were obtained using CGM and corrected for blood glucose values obtained via participant-administered finger-stick. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.
Measured: Baseline (Day -2) and Day 13
Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal
The peak postprandial glucose level during the 3 hours post meal minus the preprandial glucose level 1 hour before meal was determined for corrected CGM values at Baseline and Day 13 for breakfast, lunch, and dinner. Meals were standardized with respect to total calories, and protein, fat, and carbohydrate composition as well as timing of administration. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates better control of postprandial glucose.
Measured: Baseline (Day -2) and Day 13
Change From Baseline in 24-hour Mean Glucose Level
The mean glucose level over 24-hours at Baseline and Day 13 was determined using CGM values corrected for participant-administered finger-stick values. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.
Measured: Baseline (Day -2) and Day 13
Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)
Hypoglycemia, defined as low blood glucose, is a common side effect of medications used to treat diabetes mellitus type 2. The percentage of hypoglycemic corrected CGM readings (sensor glucose <70, <60, <50 mg/dL) over a 24-hour period were determined at baseline and Day 13. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates improvement in occurrence of hypoglycemia.
Measured: Baseline (Day -2) and Day 13

Timeline

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

4 Feb 201515 Dec 2015

First posted17 Dec 2014 (estimated)
Study start4 Feb 2015
Primary completion15 Dec 2015
Study completion15 Dec 2015

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 (1)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02318693
Sponsor's protocol ID: 0431-355
Other IDs: 152867
Status last verified: Jul 2018
First submitted: 12 Dec 2014
Last updated: 21 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Suzuki R, Eiki JI, Moritoyo T, Furihata K, Wakana A, Ohta Y, Tokita S, Kadowaki T. Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naive Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Sep;20(9):2274-2281. doi: 10.1111/dom.13364. Epub 2018 Jun 11.
PubMed 29770541

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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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Comparative Clinical Trial to Study the Efficacy of Sitagliptin and Glibenclamide in a Short Term Treatment on the Daily Glucose Variability Using Continuous Glucose Monitoring (CGM) in Japanese Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02318693
Acronym / sponsor ID: 0431-355
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 4 Feb 2015 (actual)
Primary completion: 15 Dec 2015 (actual)
Study completion: 15 Dec 2015 (actual)
First posted: 17 Dec 2014 (estimated)
Results: Posted 23 Jan 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
Sitagliptin 50 mg	Experimental	Drug: SitagliptinSitagliptin 50 mg administered orally once daily before breakfast for 14 days.
Glibenclamide 2.50 mg TDD	Active comparator	Drug: GlibenclamideGlibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Japanese participants with a diagnosis of Type 2 diabetes mellitus

Key exclusion criteria (2 listed)

History of Type 1 diabetes mellitus or ketoacidosis
History of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation

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: MK-0431Sitagliptin 50 mg orally once a day before breakfast for 14 days	Drug	Sitagliptin 50 mg
GlibenclamideGlibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days	Drug	Glibenclamide 2.50 mg TDD

Primary outcome

Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13
Time frame: Baseline (Day -2) and Day 13
MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.

4 secondary outcomes

Change From Baseline in the Standard Deviation of Blood Glucose Levels
Time frame: Baseline (Day -2) and Day 13
Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal
Time frame: Baseline (Day -2) and Day 13
Change From Baseline in 24-hour Mean Glucose Level
Time frame: Baseline (Day -2) and Day 13
Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)
Time frame: Baseline (Day -2) and Day 13

Results and safety

Results posted to the registry on 23 Jan 2017, 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 50 mg	26	26
Glibenclamide 2.50 mg TDD	27	26

Primary outcome: Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13

Time frame: Baseline (Day -2) and Day 13. Least squares mean (95% Confidence Interval). Unit: mg/dL

Measure	Sitagliptin 50 mg n = 26	Glibenclamide 2.50 mg TDD n = 26
Value	-18.5 (-30.0 to -7.1)	-9.7 (-21.1 to 1.6)

Sitagliptin 50 mg vs Glibenclamide 2.50 mg TDD: LS Means Difference: -8.8 (95% CI -23.8 to 6.2), p = 0.245, constrained longitudinal analysis model

Population analysed: The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 50 mg	0 of 26 (0%)	11 of 26 (42.3%)	Not reported
Glibenclamide 2.50 mg TDD	0 of 26 (0%)	10 of 26 (38.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29770541Suzuki R, Eiki JI, Moritoyo T, Furihata K, Wakana A, Ohta Y, Tokita S, Kadowaki T. Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naive Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Sep;20(9):2274-2281. doi: 10.1111/dom.13364. Epub 2018 Jun 11.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/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 Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sitagliptin and Glibenclamide 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 1 inclusion and 2 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 Aug 2018. 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 23 Jan 2017). 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?

Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13 (time frame: Baseline (Day -2) and Day 13). 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 NCT02318693, which also lists 1 linked publication.

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 Aug 2018.