Glucose IntolerancePhase 2NCT01405911

Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

A Phase 2 study testing Sitagliptin 25 mg and Sitagliptin 50 mg in people with Glucose Intolerance, 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 is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Glucose Intolerance
What is being tested?: Sitagliptin 25 mg and Sitagliptin 50 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 242 participants
Where: No sites listed yet
Study dates: 16 Aug 2011to 9 Apr 2012
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Impaired glucose tolerance
On diet/exercise therapy
Unlikely to conceive
Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

Who cannot join

History of diabetes mellitus
Disease or condition of clear or likely glucose tolerance disorder
Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

About this study

Official title: A Phase II, Randomized, Placebo-Controlled, Parallel-group, Double-Blind, Dose Response Finding Clinical Trial to Study the Efficacy and Safety of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

Conditions: Glucose Intolerance
Being tested: Placebo for Sitagliptin 25 mg, Placebo for Sitagliptin 50 mg, Sitagliptin 25 mg, Sitagliptin 50 mg
Medical subject headings: Glucose Intolerance

What participants receive

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

Placebo for Sitagliptin 25 mgDrug
1 tablet orally once daily before breakfast for 8 weeks
Placebo for Sitagliptin 50 mgDrug
1 tablet orally once daily before breakfast for 8 weeks
Sitagliptin 25 mgDrug
Also called MK-0431/ONO-5435
1 tablet orally once daily before breakfast for 8 weeks
Sitagliptin 50 mgDrug
Also called MK-0431/ONO-5435
1 tablet orally once daily before breakfast for 8 weeks

Study groups in NCT01405911
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks. Receives: Drug: Placebo for Sitagliptin 25 mg; Drug: Placebo for Sitagliptin 50 mg
Sitagliptin 25 mg	Experimental	Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks. Receives: Drug: Placebo for Sitagliptin 50 mg; Drug: Sitagliptin 25 mg
Sitagliptin 50 mg	Experimental	Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks. Receives: Drug: Placebo for Sitagliptin 25 mg; Drug: Sitagliptin 50 mg

What is being measured

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

Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8
Glucose total AUC 0-2 hours for MTT was measured at Baseline (Week 0) and at Week 8. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 8, participants received study drug or placebo 30 minutes prior to consuming a standard meal.
Measured: Baseline (Week 0) and Week 8
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to 10 weeks
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to 8 weeks

Secondary outcomes (1)

Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7
Glucose total AUC 0-2 hours for 75 g OGTT was measured at Baseline (Week -1) and at Week 7. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at 75 g glucose loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 7, participants received study drug or placebo 30 minutes prior to loading 75 g glucose solution.
Measured: Baseline (Week -1) and Week 7

Timeline

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

16 Aug 20119 Apr 2012

First posted29 Jul 2011 (estimated)
Study start16 Aug 2011
Primary completion9 Apr 2012
Study completion9 Apr 2012

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 Glucose IntoleranceStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01405911
Sponsor's protocol ID: 0431-105
Other IDs: MK-0431-105
Status last verified: Jan 2020
First submitted: 28 Jul 2011
Last updated: 18 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Kaku K, Kadowaki T, Terauchi Y, Okamoto T, Sato A, Okuyama K, Arjona Ferreira JC, Goldstein BJ. Sitagliptin improves glycaemic excursion after a meal or after an oral glucose load in Japanese subjects with impaired glucose tolerance. Diabetes Obes Metab. 2015 Nov;17(11):1033-41. doi: 10.1111/dom.12507. Epub 2015 Jul 17.
PubMed 26094974

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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Placebo-Controlled, Parallel-group, Double-Blind, Dose Response Finding Clinical Trial to Study the Efficacy and Safety of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
ClinicalTrials.gov ID: NCT01405911
Acronym / sponsor ID: 0431-105
Conditions: Glucose Intolerance
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 16 Aug 2011 (actual)
Primary completion: 9 Apr 2012 (actual)
Study completion: 9 Apr 2012 (actual)
First posted: 29 Jul 2011 (estimated)
Results: Posted 26 Dec 2019

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: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo for Sitagliptin 25 mg, Drug: Placebo for Sitagliptin 50 mgParticipants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
Sitagliptin 25 mg	Experimental	Drug: Placebo for Sitagliptin 50 mg, Drug: Sitagliptin 25 mgParticipants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
Sitagliptin 50 mg	Experimental	Drug: Placebo for Sitagliptin 25 mg, Drug: Sitagliptin 50 mgParticipants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.

Who may qualify

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

Key inclusion criteria (4 listed)

Impaired glucose tolerance
On diet/exercise therapy
Unlikely to conceive
Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

Key exclusion criteria (3 listed)

History of diabetes mellitus
Disease or condition of clear or likely glucose tolerance disorder
Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

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
Placebo for Sitagliptin 25 mg1 tablet orally once daily before breakfast for 8 weeks	Drug	Placebo, Sitagliptin 50 mg
Placebo for Sitagliptin 50 mg1 tablet orally once daily before breakfast for 8 weeks	Drug	Placebo, Sitagliptin 25 mg
Sitagliptin 25 mgAlso: MK-0431/ONO-54351 tablet orally once daily before breakfast for 8 weeks	Drug	Sitagliptin 25 mg
Sitagliptin 50 mgAlso: MK-0431/ONO-54351 tablet orally once daily before breakfast for 8 weeks	Drug	Sitagliptin 50 mg

Primary outcome

Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8
Time frame: Baseline (Week 0) and Week 8
Glucose total AUC 0-2 hours for MTT was measured at Baseline (Week 0) and at Week 8. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 8, participants received study drug or placebo 30 minutes prior to consuming a standard meal.
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
Time frame: Up to 10 weeks
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
Time frame: Up to 8 weeks
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

1 secondary outcome

Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7
Time frame: Baseline (Week -1) and Week 7

Results and safety

Results posted to the registry on 26 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	83	79
Sitagliptin 25 mg	82	79
Sitagliptin 50 mg	77	76

Primary outcome: Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8

Time frame: Baseline (Week 0) and Week 8. Least squares mean (95% Confidence Interval). Unit: Percent change

Measure	Placebo n = 82	Sitagliptin 25 mg n = 82	Sitagliptin 50 mg n = 77
Value	-2.42 (-4.48 to -0.31)	-9.52 (-11.43 to -7.57)	-11.49 (-13.40 to -9.55)

Placebo vs Sitagliptin 25 mg: Difference in Least Squares Means: -7.11 (95% CI -9.85 to -4.36), p <0.001, Constrained Longitudinal Data Analysis
Placebo vs Sitagliptin 50 mg: Difference in Least Squares Means: -9.08 (95% CI -11.82 to -6.33), p <0.001, Constrained Longitudinal Data Analysis
Sitagliptin 25 mg vs Sitagliptin 50 mg: Difference in Least Squares Means: -1.97 (95% CI -4.61 to 0.67), p = 0.143, Constrained Longitudinal Data Analysis

Population analysed: All participants, as randomized, who received at least one dose of study treatment and have a baseline measurement or post-randomization measurement for the analysis endpoint subsequent to study treatment.

Primary outcome: Percentage of Participants Who Experienced One or More Adverse Events (AEs)

Time frame: Up to 10 weeks. Number. Unit: Percentage of participants

Measure	Placebo n = 81	Sitagliptin 25 mg n = 82	Sitagliptin 50 mg n = 78
Value	30.9	34.1	41.0

Population analysed: All randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the actual study treatment they received. Due to a prescription error, one participant who was randomized to the placebo group took sitagliptin 50 mg.

Primary outcome: Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)

Time frame: Up to 8 weeks. Number. Unit: Percentage of participants

Measure	Placebo n = 81	Sitagliptin 25 mg n = 82	Sitagliptin 50 mg n = 78
Value	0.0	0.0	0.0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 10 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 81 (0%)	13 of 81 (16%)	0 of 81
Sitagliptin 25 mg	0 of 82 (0%)	14 of 82 (17.1%)	0 of 82
Sitagliptin 50 mg	0 of 78 (0%)	11 of 78 (14.1%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26094974Kaku K, Kadowaki T, Terauchi Y, Okamoto T, Sato A, Okuyama K, Arjona Ferreira JC, Goldstein BJ. Sitagliptin improves glycaemic excursion after a meal or after an oral glucose load in Japanese subjects with impaired glucose tolerance. Diabetes Obes Metab. 2015 Nov;17(11):1033-41. doi: 10.1111/dom.12507. Epub 2015 Jul 17.
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 Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sitagliptin 25 mg and Sitagliptin 50 mg in people with Glucose Intolerance, 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 3 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 18 Jan 2020. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Dec 2019). 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?

Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 (time frame: Baseline (Week 0) and Week 8). The study lists 3 primary outcomes in all. 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 NCT01405911, 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 18 Jan 2020.