Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00875394
Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
A Phase 3 study testing sitagliptin phosphate and Comparator: metformin in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Merck Sharp & Dohme LLC.
Trial summary
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy Read more about this study
- Who is it for?
- Ages 30 to 78 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- sitagliptin phosphate and Comparator: metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2007to 27 Jun 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 30 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 30-78 Years Of Age On The Day Of Signing Informed Consent
- Patient Is Currently On Metformin Therapy (1500 Mg/Day)
- Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
- Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
- Patient Has An A1c of 6.5 % - 11.0%
Who cannot join
- Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis
About this study
Official title: A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- sitagliptin phosphate, Comparator: metformin, Comparator: Antidiabetic Standard of Care
- 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 sitagliptin
sitagliptin 100 mg Once a day (QD) for 24 weeks
Comparator: metforminDrug
Also called metformin
metformin 850 mg Twice a day (BID) for 24 weeks
Comparator: metforminDrug
Also called metformin
metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
Comparator: Antidiabetic Standard of CareDrug
Patient can take any oral antidiabetic drug (other than metformin)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | sitagliptin + metformin Receives: Drug: sitagliptin phosphate; Drug: Comparator: metformin |
| 2 | Active comparator | metformin + any other oral antidiabetic drug Receives: Drug: Comparator: metformin; Drug: Comparator: Antidiabetic Standard of Care |
| 3 | Active comparator | metformin Receives: Drug: Comparator: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study start1 Feb 2007
- Primary completion27 Jun 2008
- Study completion27 Jun 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.
- 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
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875394
- Sponsor's protocol ID
- 0431-189
- Other IDs
- 2009_571
- Status last verified
- Apr 2017
- First submitted
- 1 Apr 2009
- Last updated
- 30 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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin
- ClinicalTrials.gov ID
- NCT00875394
- Acronym / sponsor ID
- 0431-189
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2007 (actual)
- Primary completion
- 27 Jun 2008 (actual)
- Study completion
- 27 Jun 2008 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 20 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: sitagliptin phosphate, Drug: Comparator: metforminsitagliptin + metformin |
| 2 | Active comparator | Drug: Comparator: metformin, Drug: Comparator: Antidiabetic Standard of Caremetformin + any other oral antidiabetic drug |
| 3 | Active comparator | Drug: Comparator: metforminmetformin |
Who may qualify
- Ages
- 30 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient Has Type 2 Diabetes Mellitus
- Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
- Patient Is Currently On Metformin Therapy (1500 Mg/Day)
- Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
- Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
Key exclusion criteria (1 listed)
- Patient Has A History Of 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 phosphateAlso: sitagliptinsitagliptin 100 mg Once a day (QD) for 24 weeks | Drug | 1 |
| Comparator: metforminAlso: metforminmetformin 850 mg Twice a day (BID) for 24 weeks | Drug | 1, 2 |
| Comparator: metforminAlso: metforminmetformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks | Drug | 3 |
| Comparator: Antidiabetic Standard of CarePatient can take any oral antidiabetic drug (other than metformin) | Drug | 2 |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24
Time frame: Baseline and 24 weeks
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 6 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 30 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 20 Apr 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 Glycosylated Hemoglobin A1C (A1C) 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?
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 30 May 2017.