Diabetes Mellitus, Type 2NCT01357148
A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)
An observational study of Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC.
Trial summary
The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Sitagliptin Phosphate/Metformin HCl (JANUMET®)
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to May 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with type 2 diabetes mellitus who are treated with sitagliptin phosphate/metformin HCl as per the standard of care in a physician's practice
Who may be able to join
- Must be taking sitagliptin phosphate/metformin HCl (JANUMET®) for the treatment of type 2 diabetes mellitus
- Treating physician must agree to provide information regarding the participant's treatment
Who cannot join
None listed.
About this study
Official title: Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol
The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Sitagliptin Phosphate/Metformin HCl (JANUMET®)
- 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 HCl (JANUMET®)Drug
Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with sitagliptin phosphate/metformin HCl | Not described Receives: Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Adverse Event
Measured: Up to approximately 28 months
Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl
Measured: Up to approximately 28 months
Number of Participants With Concomitant Conditions
Measured: Up to approximately 28 months
Number of Participants Taking Concomitant Medications
Measured: Up to approximately 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMar 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Completion of MK-0431A-235 was rendered unnecessary, as the local oversight authority accepted in its stead the results of another study \[MK-0431-234\].
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, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357148
- Sponsor's protocol ID
- 0431A-235
- Status last verified
- Aug 2015
- First submitted
- 18 May 2011
- Last updated
- 10 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol
- ClinicalTrials.gov ID
- NCT01357148
- Acronym / sponsor ID
- 0431A-235
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Completion of MK-0431A-235 was rendered unnecessary, as the local oversight authority accepted in its stead the results of another study \[MK-0431-234\].
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Posted 7 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants treated with sitagliptin phosphate/metformin HCl | – | Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with type 2 diabetes mellitus who are treated with sitagliptin phosphate/metformin HCl as per the standard of care in a physician's practice
Key inclusion criteria (2 listed)
- Must be taking sitagliptin phosphate/metformin HCl (JANUMET®) for the treatment of type 2 diabetes mellitus
- Treating physician must agree to provide information regarding the participant's treatment
Key exclusion criteria (0 listed)
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 HCl (JANUMET®)Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice. | Drug | Participants treated with sitagliptin phosphate/metformin HCl |
Primary outcome
Number of Participants With an Adverse Event
Time frame: Up to approximately 28 months
Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl
Time frame: Up to approximately 28 months
Number of Participants With Concomitant Conditions
Time frame: Up to approximately 28 months
Number of Participants Taking Concomitant Medications
Time frame: Up to approximately 28 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, 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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 10 Aug 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2012). 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?
Number of Participants With an Adverse Event (time frame: Up to approximately 28 months). The study lists 4 primary outcomes in all. 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 10 Aug 2015.