Type 2 Diabetes MellitusPhase 3NCT00532935

MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

A Phase 3 study testing sitagliptin phosphate (+) metformin hydrochloride and Comparator: pioglitazone 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

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes Read more about this study

Who is it for?: Ages 18 to 78 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: sitagliptin phosphate (+) metformin hydrochloride and Comparator: pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 517 participants
Where: No sites listed yet
Study dates: 26 Jan 2008to 23 Oct 2009
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 to 78 years
All sexes
No healthy volunteers
Adult, Older adult

General Inclusion Criteria:

Patient has type 2 diabetes mellitus
Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

About this study

Official title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus
Being tested: sitagliptin phosphate (+) metformin hydrochloride, Comparator: pioglitazone
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 phosphate (+) metformin hydrochlorideDrug
Also called Janumet
sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period
Comparator: pioglitazoneDrug
Also called pioglitazone
pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.

Study groups in NCT00532935
Study group	Role	What they receive
1	Experimental	Sitagliptin phosphate (+) metformin hydrochloride Receives: Drug: sitagliptin phosphate (+) metformin hydrochloride
2	Active comparator	pioglitazone Receives: Drug: Comparator: pioglitazone

What is being measured

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

Change From Baseline in A1C at Week 32
A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent
Measured: Baseline and Week 32

Secondary outcomes (4)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1
Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone
Measured: Baseline and Week 1
Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32
Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG
Measured: Baseline and Week 32
Change From Baseline in FPG at Week 32
Change from baseline reflects the Week 32 FPG minus the baseline FPG
Measured: Baseline and Week 32
Percent of Participants With A1C <7.0% at Week 32
Measured: Week 32

Timeline

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

26 Jan 200823 Oct 2009

First posted21 Sep 2007 (estimated)
Study start26 Jan 2008
Primary completion23 Oct 2009
Study completion23 Oct 2009

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 517 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00532935
Sponsor's protocol ID: 0431A-066
Other IDs: 2007_510
Status last verified: May 2017
First submitted: 19 Sep 2007
Last updated: 9 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
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

Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.
PubMed 22059736

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 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00532935
Acronym / sponsor ID: 0431A-066
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 517 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 26 Jan 2008 (actual)
Primary completion: 23 Oct 2009 (actual)
Study completion: 23 Oct 2009 (actual)
First posted: 21 Sep 2007 (estimated)
Results: Posted 18 Oct 2010

Clinical summary

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

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: sitagliptin phosphate (+) metformin hydrochlorideSitagliptin phosphate (+) metformin hydrochloride
2	Active comparator	Drug: Comparator: pioglitazonepioglitazone

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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 phosphate (+) metformin hydrochlorideAlso: Janumetsitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period	Drug	1
Comparator: pioglitazoneAlso: pioglitazonepioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.	Drug	2

Primary outcome

Change From Baseline in A1C at Week 32
Time frame: Baseline and Week 32
A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent

4 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1
Time frame: Baseline and Week 1
Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32
Time frame: Baseline and Week 32
Change From Baseline in FPG at Week 32
Time frame: Baseline and Week 32
Percent of Participants With A1C <7.0% at Week 32
Time frame: Week 32

Results and safety

Results posted to the registry on 18 Oct 2010, 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/Metformin Fixed-Dose Combination	261	210
Pioglitazone	256	204

Primary outcome: Change From Baseline in A1C at Week 32

Time frame: Baseline and Week 32. Least squares mean (95% Confidence Interval). Unit: Percent of glycosylated hemoglobin (A1C)

Measure	Sitagliptin/Metformin Fixed-Dose Combination n = 253	Pioglitazone n = 246
Value	-1.86 (-2.00 to -1.73)	-1.39 (-1.53 to -1.26)

Sitagliptin/Metformin Fixed-Dose Combination vs Pioglitazone: Mean Difference (Net): -0.47 (95% CI -0.66 to -0.28), p <0.001, ANCOVA

Population analysed: The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 through Week 32. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin/Metformin Fixed-Dose Combination	11 of 261 (4.2%)	94 of 261 (36%)	Not reported
Pioglitazone	8 of 256 (3.1%)	68 of 256 (26.6%)	Not reported

Limitations and caveats (from the sponsor): Unknown to the Sponsor and the investigators, two patients in the study were randomized twice (each at two different sites). Data for these patients were deemed unreliable and excluded from all analyses (efficacy and safety).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22059736Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.
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 Type 2 Diabetes Mellitus

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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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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 phosphate (+) metformin hydrochloride and Comparator: pioglitazone 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?

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 9 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 18 Oct 2010). 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 A1C at Week 32 (time frame: Baseline and Week 32). 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 NCT00532935, 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 9 Jun 2017.