Type 2 Diabetes MellitusPhase 3NCT00482729

MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

A Phase 3 study testing sitagliptin phosphate (+) metformin hydrochloride 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

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus. 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 metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,246 participants
Where: No sites listed yet
Study dates: 19 Jun 2007to 27 Apr 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

Who may be able to join

Patient has type 2 diabetes mellitus
Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
Patient is a male, or a female who is unlikely to conceive

Who cannot join

Patient has type 1 diabetes mellitus or history of ketoacidosis

About this study

Official title: A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Conditions: Type 2 Diabetes Mellitus
Being tested: sitagliptin phosphate (+) metformin hydrochloride, metformin
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 MK0431A, Janumet™
sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
metforminDrug
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Study groups in NCT00482729
Study group	Role	What they receive
1	Experimental	Arm 1: drug Receives: Drug: sitagliptin phosphate (+) metformin hydrochloride
2	Active comparator	Arm 2: active comparator Receives: Drug: metformin

What is being measured

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

Change From Baseline in Hemoglobin A1c (A1C) at Week 18
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and Week 18

Secondary outcomes (2)

Number of Patients With A1C < 7.0% at Week 18
Measured: Week 18
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.
Measured: Baseline and Week 18

Timeline

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

19 Jun 200727 Apr 2009

First posted5 Jun 2007 (estimated)
Study start19 Jun 2007
Primary completion3 Nov 2008
Study completion27 Apr 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 (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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00482729
Sponsor's protocol ID: 0431A-079
Other IDs: MK0431A-079, 2007_548
Status last verified: May 2017
First submitted: 31 May 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

Reasner C, Olansky L, Seck TL, Williams-Herman DE, Chen M, Terranella L, Johnson-Levonas AO, Kaufman KD, Goldstein BJ. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Jul;13(7):644-52. doi: 10.1111/j.1463-1326.2011.01390.x.
PubMed 21410627
Olansky L, Reasner C, Seck TL, Williams-Herman DE, Chen M, Terranella L, Mehta A, Kaufman KD, Goldstein BJ. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab. 2011 Sep;13(9):841-9. doi: 10.1111/j.1463-1326.2011.01416.x.
PubMed 21535346

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

Official title: A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)
ClinicalTrials.gov ID: NCT00482729
Acronym / sponsor ID: 0431A-079
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,246 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 19 Jun 2007 (actual)
Primary completion: 3 Nov 2008 (actual)
Study completion: 27 Apr 2009 (actual)
First posted: 5 Jun 2007 (estimated)
Results: Posted 15 Mar 2010

Clinical summary

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

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

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 hydrochlorideArm 1: drug
2	Active comparator	Drug: metforminArm 2: active comparator

Who may qualify

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

Key inclusion criteria (5 listed)

Patient has type 2 diabetes mellitus
Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
Patient is a male, or a female who is unlikely to conceive

Key exclusion criteria (1 listed)

Patient has type 1 diabetes mellitus or history of ketoacidosis

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: MK0431A, Janumet™sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.	Drug	1
metforminmetformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period	Drug	2

Primary outcome

Change From Baseline in Hemoglobin A1c (A1C) at Week 18
Time frame: Baseline and Week 18
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

2 secondary outcomes

Number of Patients With A1C < 7.0% at Week 18
Time frame: Week 18
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Time frame: Baseline and Week 18

Results and safety

Results posted to the registry on 15 Mar 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
Sita/Met FDC	626	409
Metformin	624	406

Primary outcome: Change From Baseline in Hemoglobin A1c (A1C) at Week 18

Time frame: Baseline and Week 18. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Sita/Met FDC n = 559	Metformin n = 564
Value	-2.37 (-2.49 to -2.24)	-1.76 (-1.88 to -1.64)

Sita/Met FDC vs Metformin: Mean Difference (Net): -0.60 (95% CI -0.78 to -0.43), p <0.001, ANCOVA

Population analysed: The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥ 1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 through Week 44. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sita/Met FDC	28 of 625 (4.5%)	173 of 625 (27.7%)	Not reported
Metformin	38 of 621 (6.1%)	185 of 621 (29.8%)	Not reported

Limitations and caveats (from the sponsor): Site 079011301 was non-compliant with Good Clinical Practice (GCP). Data from the 4 patients at this site are included in the Participant Flow summary, but are excluded from all other summaries and analyses.

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 21410627Reasner C, Olansky L, Seck TL, Williams-Herman DE, Chen M, Terranella L, Johnson-Levonas AO, Kaufman KD, Goldstein BJ. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Jul;13(7):644-52. doi: 10.1111/j.1463-1326.2011.01390.x.
Results publication: PubMed 21535346Olansky L, Reasner C, Seck TL, Williams-Herman DE, Chen M, Terranella L, Mehta A, Kaufman KD, Goldstein BJ. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab. 2011 Sep;13(9):841-9. doi: 10.1111/j.1463-1326.2011.01416.x.
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.

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 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 5 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 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 15 Mar 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 Hemoglobin A1c (A1C) at Week 18 (time frame: Baseline and Week 18). 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 NCT00482729, 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 9 Jun 2017.