Type 2 Diabetes MellitusPhase 3NCT00449930

Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

A Phase 3 study testing sitagliptin phosphate and Comparator: metformin hydrochloride 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 sitagliptin 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 and Comparator: metformin hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,050 participants
Where: No sites listed yet
Study dates: 1 Mar 2007to 25 Jul 2008
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 (T2DM)
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 therapy (insulin or oral) within the prior 4 months

About this study

Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

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

Conditions: Type 2 Diabetes Mellitus
Being tested: sitagliptin phosphate, Comparator: metformin hydrochloride
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 phosphateDrug
Also called MK0431
(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period
Comparator: metformin hydrochlorideDrug
(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.

Study groups in NCT00449930
Study group	Role	What they receive
1	Experimental	Drug Receives: Drug: sitagliptin phosphate
2	Active comparator	Active comparator Receives: Drug: Comparator: metformin hydrochloride

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 24
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Measured: Baseline and 24 weeks

Secondary outcomes (4)

Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea
Measured: Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea
Measured: Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain
Measured: Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting
Measured: Baseline to Week 24

Timeline

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

1 Mar 200725 Jul 2008

First posted21 Mar 2007 (estimated)
Study start1 Mar 2007
Primary completion25 Jul 2008
Study completion25 Jul 2008

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: 1,050 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00449930
Sponsor's protocol ID: 0431-049
Other IDs: MK0431-049, 2006_561
Status last verified: Apr 2017
First submitted: 19 Mar 2007
Last updated: 11 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

Aschner P, Katzeff HL, Guo H, Sunga S, Williams-Herman D, Kaufman KD, Goldstein BJ; Sitagliptin Study 049 Group. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Mar;12(3):252-61. doi: 10.1111/j.1463-1326.2009.01187.x. Epub 2009 Nov 25.
PubMed 20070351

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 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00449930
Acronym / sponsor ID: 0431-049
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,050 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Mar 2007 (actual)
Primary completion: 25 Jul 2008 (actual)
Study completion: 25 Jul 2008 (actual)
First posted: 21 Mar 2007 (estimated)
Results: Posted 11 Aug 2009

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 sitagliptin 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 phosphateDrug
2	Active comparator	Drug: Comparator: metformin hydrochlorideActive comparator

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 phosphateAlso: MK0431(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period	Drug	1
Comparator: metformin hydrochloride(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.	Drug	2

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time frame: Baseline and 24 weeks
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

4 secondary outcomes

Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea
Time frame: Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea
Time frame: Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain
Time frame: Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 11 Aug 2009, 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 100 mg	528	467
Metformin	522	447

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

Time frame: Baseline and 24 weeks. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Sitagliptin 100 mg n = 455	Metformin n = 439
Value	-0.43 (-0.48 to -0.38)	-0.57 (-0.62 to -0.51)

Sitagliptin 100 mg vs Metformin: Mean Difference (Net): 0.14 (95% CI 0.06 to 0.21)

Population analysed: The per protocol population required that a patient had measurements both at baseline and at Week 24, and did not have any major protocol violations (e.g. drug compliance \<85%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.

4 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 100 mg	10 of ?	19 of ?	Not reported
Metformin	8 of ?	57 of ?	Not reported

Limitations and caveats (from the sponsor): Site 0490125 was non-compliant with Good Clinical Practice (GCP). Data from the 8 patients at this site were removed from all analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20070351Aschner P, Katzeff HL, Guo H, Sunga S, Williams-Herman D, Kaufman KD, Goldstein BJ; Sitagliptin Study 049 Group. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Mar;12(3):252-61. doi: 10.1111/j.1463-1326.2009.01187.x. Epub 2009 Nov 25.
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 and Comparator: metformin hydrochloride 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 11 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 11 Aug 2009). 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 24 (time frame: Baseline and 24 weeks). 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 NCT00449930, 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 11 May 2017.