Type 2 Diabetes MellitusNCT01062048
Januvia Re-examination Study (MK-0431-181)
An observational study of Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Sitagliptin, Sulfonylurea and Insulin
- Type of treatment
- Pill or oral medicine
- How many people
- 3,483 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Korean participants with Type 2 Diabetes Mellitus being treated with Januvia
Who may be able to join
- Type 2 Diabetes Mellitus
- Treated With Januvia within local label for the first time
- Treated with Januvia for more than or equal to 24 weeks
Who cannot join
- Contraindication to Januvia according to the local label
- Treated with Januvia before contract and out of enrollment period
About this study
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice
The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sitagliptin, Sulfonylurea, Insulin
- 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.
SitagliptinDrug
Also called Januvia
Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label
SulfonylureaDrug
Sulfonylurea administered in general use according to the local label
InsulinBiological
Insulin administered in general use according to the local label
| Study group | Role | What they receive |
|---|---|---|
| All participants | Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years) Receives: Drug: Sitagliptin; Drug: Sulfonylurea; Biological: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with any adverse experience
Measured: up to 14 days following cessation of treatment
Mean change in Hemoglobin A1c (HbA1c)
Measured: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Mean change in fasting plasma glucose (FPG)
Measured: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Mean change in 2hr-postprandial glucose (PPG)
Measured: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startOct 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062048
- Sponsor's protocol ID
- 0431-181
- Other IDs
- 2010_003
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2010
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice
- ClinicalTrials.gov ID
- NCT01062048
- Acronym / sponsor ID
- 0431-181
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,483 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Drug: Sitagliptin, Drug: Sulfonylurea, Biological: InsulinParticipants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Korean participants with Type 2 Diabetes Mellitus being treated with Januvia
Key inclusion criteria (3 listed)
- Type 2 Diabetes Mellitus
- Treated With Januvia within local label for the first time
- Treated with Januvia for more than or equal to 24 weeks
Key exclusion criteria (2 listed)
- Contraindication to Januvia according to the local label
- Treated with Januvia before contract and out of enrollment period
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 |
|---|---|---|
| SitagliptinAlso: JanuviaSitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label | Drug | All participants |
| SulfonylureaSulfonylurea administered in general use according to the local label | Drug | All participants |
| InsulinInsulin administered in general use according to the local label | Biological | All participants |
Primary outcome
Percentage of participants with any adverse experience
Time frame: up to 14 days following cessation of treatment
Mean change in Hemoglobin A1c (HbA1c)
Time frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Mean change in fasting plasma glucose (FPG)
Time frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Mean change in 2hr-postprandial glucose (PPG)
Time frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 2 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 5 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants with any adverse experience (time frame: up to 14 days following cessation of treatment). 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 5 Feb 2016.