Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00837577

MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

A Phase 3 study testing Sitagliptin and Voglibose in people with Diabetes Mellitus, Non-Insulin-Dependent, 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

The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?: Sitagliptin and Voglibose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: No sites listed yet
Study dates: 5 Feb 2009to 11 Aug 2010
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy

Who cannot join

Patients Have A History Of Type 1 Diabetes Mellitus

About this study

Official title: A Phase III, Randomized, Placebo-controlled, Double-blind Clinical Trial and Subsequent Open-label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Voglibose Monotherapy

Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Being tested: Comparator: Placebo, Sitagliptin, Voglibose
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.

Comparator: PlaceboDrug
Placebo to sitagliptin once daily for 12 weeks (double-blind period)
SitagliptinDrug
Also called Januvia, MK0431, ONO-5435
Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period).
Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.
VogliboseDrug
All participants received a stable dose of voglibose, in
accordance with the package insert, throughout the study.

Study groups in NCT00837577
Study group	Role	What they receive
Sitagliptin/Sitagliptin	Experimental	Not described Receives: Drug: Sitagliptin; Drug: Voglibose
Placebo/Sitagliptin	Experimental	Not described Receives: Drug: Comparator: Placebo; Drug: Sitagliptin; Drug: Voglibose

What is being measured

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

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).
Measured: Baseline and Week 12

Secondary outcomes (2)

Change From Baseline in 2-hour Postprandial Glucose at Week 12
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Measured: Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Measured: Baseline and Week 12

Timeline

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

5 Feb 200911 Aug 2010

First posted5 Feb 2009 (estimated)
Study start5 Feb 2009
Primary completion11 Aug 2010
Study completion11 Aug 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 (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00837577
Sponsor's protocol ID: 0431-104
Other IDs: 2009_535
Status last verified: Apr 2017
First submitted: 3 Feb 2009
Last updated: 15 May 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

Tajima N, Kadowaki T, Okamoto T, Sato A, Okuyama K, Minamide T, Arjona Ferreira JC. Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes. J Diabetes Investig. 2013 Nov 27;4(6):595-604. doi: 10.1111/jdi.12116. Epub 2013 Jul 21.
PubMed 24843714

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 Diabetes Mellitus, Non-Insulin-Dependent trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Placebo-controlled, Double-blind Clinical Trial and Subsequent Open-label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Voglibose Monotherapy
ClinicalTrials.gov ID: NCT00837577
Acronym / sponsor ID: 0431-104
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 5 Feb 2009 (actual)
Primary completion: 11 Aug 2010 (actual)
Study completion: 11 Aug 2010 (actual)
First posted: 5 Feb 2009 (estimated)
Results: Posted 13 Sep 2011

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: 2

Arm	Type	Receives
Sitagliptin/Sitagliptin	Experimental	Drug: Sitagliptin, Drug: Voglibose
Placebo/Sitagliptin	Experimental	Drug: Comparator: Placebo, Drug: Sitagliptin, Drug: Voglibose

Who may qualify

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

Key inclusion criteria (1 listed)

Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy

Key exclusion criteria (1 listed)

Patients Have A History Of Type 1 Diabetes Mellitus

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
Comparator: PlaceboPlacebo to sitagliptin once daily for 12 weeks (double-blind period)	Drug	Placebo/Sitagliptin
SitagliptinAlso: Januvia, MK0431, ONO-5435Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period). Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.	Drug	Placebo/Sitagliptin, Sitagliptin/Sitagliptin
VogliboseAll participants received a stable dose of voglibose, in accordance with the package insert, throughout the study.	Drug	Placebo/Sitagliptin, Sitagliptin/Sitagliptin

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Time frame: Baseline and Week 12
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).

2 secondary outcomes

Change From Baseline in 2-hour Postprandial Glucose at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 13 Sep 2011, 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/Sitagliptin	70	68
Placebo/Sitagliptin	63	63

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

Time frame: Baseline and Week 12. Least squares mean (95% Confidence Interval). Unit: Percentage of glycosylated hemoglobin

Measure	Sitagliptin/Sitagliptin n = 70	Placebo/Sitagliptin n = 63
Value	-0.76 (0.42)	0.16 (0.64)

Sitagliptin/Sitagliptin vs Placebo/Sitagliptin: Least squares mean difference: -0.92 (95% CI -1.09 to -0.75), p <.001, Longitudinal data analysis (LDA)

Population analysed: Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.

2 secondary outcomes are 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/Sitagliptin (Data Through Week 12)	0 of 70 (0%)	7 of 70 (10%)	Not reported
Placebo/Sitagliptin (Data Through Week 12)	1 of 63 (1.6%)	5 of 63 (7.9%)	Not reported
Pooled Sitagliptin (Data Through Week 52)	8 of 133 (6%)	51 of 133 (38.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24843714Tajima N, Kadowaki T, Okamoto T, Sato A, Okuyama K, Minamide T, Arjona Ferreira JC. Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes. J Diabetes Investig. 2013 Nov 27;4(6):595-604. doi: 10.1111/jdi.12116. Epub 2013 Jul 21.
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

Related trials for Diabetes Mellitus, Non-Insulin-Dependent

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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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 3 study testing Sitagliptin and Voglibose in people with Diabetes Mellitus, Non-Insulin-Dependent, 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 1 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 15 May 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 13 Sep 2011). 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 Hemoglobin A1c (HbA1c) at Week 12 (time frame: Baseline and Week 12). 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 NCT00837577, 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 15 May 2017.