A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Trajenta tablet
Type of treatment: Pill or oral medicine
How many people: 3,219 participants
Where: 1 siteSouth Korea
Study dates: 16 Nov 2012to 11 Jul 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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Korean patients with T2DM

Who may be able to join

Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form

Who cannot join

Patients with previous exposure to Trajenta and current participation in clinical trials

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Study site
Multiple Locations

Other trials in South Korea

About this study

Official title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus(SELINA Study)

The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.

Read the detailed description

Study Design:

Post Marketing study- Observational study

Conditions: Diabetes Mellitus, Type 2
Being tested: Trajenta tablet
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 tabletDrug
Linagliptin

Study groups in NCT01707147
Study group	Role	What they receive
Patients with Type 2 Diabetes Mellitus		Not described Receives: Drug: Trajenta tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta
Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.
Measured: Up to 26 weeks (long-term surveillance)

Secondary outcomes (4)

Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)
Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).
Measured: Baseline and Week 24
Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment
Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of < 6.5% after 24 weeks of treatment.
Measured: 24 Weeks
Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)
Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).
Measured: 24 Weeks
Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)
Change from baseline after 24 weeks in fasting plasma glucose (FPG).
Measured: Baseline and Week 24

Timeline

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

16 Nov 201211 Jul 2017

First posted16 Oct 2012 (estimated)
Study start16 Nov 2012
Primary completion11 Jul 2017
Study completion11 Jul 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: 3,219 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01707147
Sponsor's protocol ID: 1218.104
Status last verified: Jul 2018
First submitted: 1 Oct 2012
Last updated: 11 Jan 2019
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2019. 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 (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus(SELINA Study)
ClinicalTrials.gov ID: NCT01707147
Acronym / sponsor ID: 1218.104
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 3,219 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 16 Nov 2012 (actual)
Primary completion: 11 Jul 2017 (actual)
Study completion: 11 Jul 2017 (actual)
First posted: 16 Oct 2012 (estimated)
Results: Posted 11 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.

Detailed description

Study Design:

Post Marketing study- Observational study

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with Type 2 Diabetes Mellitus	–	Drug: Trajenta tablet

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Korean patients with T2DM

Key inclusion criteria (1 listed)

Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form

Key exclusion criteria (1 listed)

Patients with previous exposure to Trajenta and current participation in clinical trials

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 tabletLinagliptin	Drug	Patients with Type 2 Diabetes Mellitus

Primary outcome

Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta
Time frame: Up to 26 weeks (long-term surveillance)
Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.

4 secondary outcomes

Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and Week 24
Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment
Time frame: 24 Weeks
Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)
Time frame: 24 Weeks
Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 11 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trajenta (Linagliptin) 5 mg	3,219	3,119

Primary outcome: Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta

Time frame: Up to 26 weeks (long-term surveillance). Number. Unit: Percentage of patients

Measure	Trajenta (Linagliptin) 5 mg n = 3119
Value	7.69

Population analysed: Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the entire surveillance period until re-examination period, up to 6 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trajenta (Linagliptin) 5 mg	49 of 3,119 (1.6%)	0 of 3,119 (0%)	2 of 3,119

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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 1 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 11 Jan 2019. 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 11 Jan 2019). 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?

Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta (time frame: Up to 26 weeks (long-term surveillance)). 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 NCT01707147.

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 Jan 2019.