Diabetes Mellitus, Type 2NCT01903356
A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in South Korea.
Trial summary
The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Trajenta duo
- How many people
- 724 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jul 2013to 10 Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean patients with T2DM
Who may be able to join
- Potential subjets must meet all of the following inclusion criteria to enter this trial:
- No previous exposure to Trajenta, Trajenta Duo
- Should have been started on Trajenta Duo in accordance with the approved label in Korea
- No current participation in clinical trials
- No metformin is inappropriate due to contraindications
- Must sign on the data release consent form
Who cannot join
- Individuals with any of the following characteristics will not be able to enter this study:
- Previous exposure to Trajenta, Trajenta Duo
- Current participation in clinical trials
- Patients for whom metformin is inappropriate due to contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.d) in Korean Patients With Type 2 Diabetes Mellitus
The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.
Read the detailed description
Study Design:
Post Marketed Study- Observational study
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Trajenta duo
- 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.
Trajenta duoDrug
Linagliptin and Metformin
| Study group | Role | What they receive |
|---|---|---|
| Patients with T2DM | Not described Receives: Drug: Trajenta duo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Adverse Events (AE)
The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo
Measured: Up to 26 weeks
Secondary outcomes (4)
Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.
This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.
Measured: Baseline and Week 24
Target Effectiveness Response Rate
Occurrence of treatment to target effectiveness response is an HbA1c under treatment of < 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c < 6.5% after 24 weeks.
Measured: 24 Weeks
Relative Effectiveness Response Rate
Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks.
Measured: 24 Weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.
This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study start11 Jul 2013
- Primary completion30 May 2017
- Study completion10 Jun 2017
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 Boehringer IngelheimThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903356
- Sponsor's protocol ID
- 1288.22
- Status last verified
- Jun 2018
- First submitted
- 16 Jul 2013
- Last updated
- 21 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.d) in Korean Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01903356
- Acronym / sponsor ID
- 1288.22
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 11 Jul 2013 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 10 Jun 2017 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Posted 21 Dec 2018
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 monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.
Detailed description
Study Design:
Post Marketed Study- Observational study
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with T2DM | – | Drug: Trajenta duo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean patients with T2DM
Key inclusion criteria (6 listed)
- No previous exposure to Trajenta, Trajenta Duo
- Should have been started on Trajenta Duo in accordance with the approved label in Korea
- No current participation in clinical trials
- No metformin is inappropriate due to contraindications
- Must sign on the data release consent form
Key exclusion criteria (4 listed)
- Individuals with any of the following characteristics will not be able to enter this study:
- Previous exposure to Trajenta, Trajenta Duo
- Current participation in clinical trials
- Patients for whom metformin is inappropriate due to contraindications
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 |
|---|---|---|
| Trajenta duoLinagliptin and Metformin | Drug | Patients with T2DM |
Primary outcome
Incidence Rate of Adverse Events (AE)
Time frame: Up to 26 weeks
The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo
4 secondary outcomes
Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.
Time frame: Baseline and Week 24
Target Effectiveness Response Rate
Time frame: 24 Weeks
Relative Effectiveness Response Rate
Time frame: 24 Weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in South Korea.
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 4 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 21 Dec 2018). 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?
Incidence Rate of Adverse Events (AE) (time frame: Up to 26 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 21 Dec 2018.