Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 51 sites in Philippines.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a prospective, non-interventional, open label, multi center, post marketing surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin among Filipino patients with type 2 Diabetes Mellitus (DM) within the study duration of 24 weeks. 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?: Linagliptin
Type of treatment: Pill or oral medicine
How many people: 678 participants
Where: 51 sitesPhilippines
Study dates: May 2012to Oct 2013
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: Filipino type 2 DM patients

Who may be able to join

Filipino of Asian race
Patient using Linagliptin within label or locally approved indication. The prescription of Linagliptin to the patient must be in the course of normal clinical practice and independent of the decision to include the patient in the study.
Male or female patients more than 18 years old
Body mass index less than or equal to 40
Diagnosed with type 2 DM
Uncontrolled type 2 DM with fasting blood sugar of more than 126 mg/dl and/or HbA1c more than 7%.

Who cannot join

Diagnosed with type 1 DM
Patients with acute illness requiring hospitalization in the past one month
Patients participating in a different study that includes an investigational drug
Patients with known hypersensitivity reaction to Linagliptin or any of tis components
Pregnant women and those women who have intentions of getting pregnant within the study duration
Nursing women
Patients with concomitant conditions that contraindicates Linagliptin use as described in its product information

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

Philippines51 sites

Boehringer Ingelheim Investigational Site 43
Agoo, La Union
Boehringer Ingelheim Investigational Site 40
Angeles City, Pampanga
Boehringer Ingelheim Investigational Site 31
Angono, Rizal
Boehringer Ingelheim Investigational Site 32
Antipolo, Rizal
Boehringer Ingelheim Investigational Site 27
Aparri, Cagayan
Boehringer Ingelheim Investigational Site 4
Batangas
Boehringer Ingelheim Investigational Site 48
Butuan City, Agusan Del Norte
Boehringer Ingelheim Investigational Site 12
Cabanatuan, Nueva Ecija
Boehringer Ingelheim Investigational Site 23
Cagayan de Oro
Boehringer Ingelheim Investigational Site 3
Caloocan
Boehringer Ingelheim Investigational Site 42
Cardona, Rizal
Boehringer Ingelheim Investigational Site 25
Cebu
Boehringer Ingelheim Investigational Site 44
Dagupan, Pangasinan
Boehringer Ingelheim Investigational Site 49
Iligan City, Lanao Del Norte
Boehringer Ingelheim Investigational Site 2
Iloilo City
Boehringer Ingelheim Investigational Site 45
Iriga City, Camarines Sur
Boehringer Ingelheim Investigational Site 20
Laoag, Ilocos Norte
Boehringer Ingelheim Investigational Site 24
Las Piñas
Boehringer Ingelheim Investigational Site 7
Legazpi, Albay
Boehringer Ingelheim Investigational Site 35
Lucena, Quezon
Boehringer Ingelheim Investigational Site 1
Makati
Boehringer Ingelheim Investigational Site 39
Malolos, Bulacan
Boehringer Ingelheim Investigational Site 37
Mandaluyong
Boehringer Ingelheim Investigational Site 28
Manila
Boehringer Ingelheim Investigational Site 5
Marikina City
Boehringer Ingelheim Investigational Site 16
Meycauyan, Bulacan
Boehringer Ingelheim Investigational Site 47
Naga City, Camarines Sur
Boehringer Ingelheim Investigational Site 15
Olongapo City
Boehringer Ingelheim Investigational Site 10
Pampanga
Boehringer Ingelheim Investigational Site 19
Paranaque City
Boehringer Ingelheim Investigational Site 51
Pasay
Boehringer Ingelheim Investigational Site 30
Pasig
Boehringer Ingelheim Investigational Site 34
Puerto Princesa, Palawan
Boehringer Ingelheim Investigational Site 26
Quezon City
Boehringer Ingelheim Investigational Site 11
Rosales, Pangasinan
Boehringer Ingelheim Investigational Site 21
San Fernando, La Union
Boehringer Ingelheim Investigational Site 9
San Fernando, Pampanga
Boehringer Ingelheim Investigational Site 13
San Jose, Nueva Ecija
Boehringer Ingelheim Investigational Site 29
San Juan City
Boehringer Ingelheim Investigational Site 8
San Pablo, Laguna
Boehringer Ingelheim Investigational Site 50
San Pedro, Laguna
Boehringer Ingelheim Investigational Site 41
Santiago City, Isabela
Boehringer Ingelheim Investigational Site 36
Sogod, Southern Leyte
Boehringer Ingelheim Investigational Site 38
Sta.Maria, Bulacan
Boehringer Ingelheim Investigational Site 6
Tacloban City
Boehringer Ingelheim Investigational Site 33
Tagbilaran, Bohol
Boehringer Ingelheim Investigational Site 14
Tuguegarao, Cagayan
Boehringer Ingelheim Investigational Site 18
Urdaneta, Pangasinan
Boehringer Ingelheim Investigational Site 46
Valencia City Bukidnon
Boehringer Ingelheim Investigational Site 17
Valenzuela, Bulacan
Boehringer Ingelheim Investigational Site 22
Zamboanga City

Other trials in Philippines

About this study

Official title: A Post-Marketing Surveillance Study on the Safety, Tolerability and Efficacy of Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type 2
Being tested: Linagliptin
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.

LinagliptinDrug
tablet

Study groups in NCT01826370
Study group	Role	What they receive
Linagliptin		Not described Receives: Drug: Linagliptin

What is being measured

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

Frequency of Adverse Events and Serious Adverse Events
Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.
Measured: Week 24

Secondary outcomes (2)

Change From Baseline to Week 24 of HbA1c
Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)
Measured: Baseline and 24 weeks
Change From Baseline to Week 24 of Fasting Blood Sugar
Change from baseline to week 24 of fasting blood sugar
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.

May 2012Oct 2013

First posted8 Apr 2013 (estimated)
Study startMay 2012
Primary completionOct 2013
Study completionOct 2013

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: Cohort
Time perspective: Prospective
Enrolment: 678 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01826370
Sponsor's protocol ID: 1218.94
Status last verified: Sep 2014
First submitted: 4 Apr 2013
Last updated: 18 Sep 2014
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

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Marketing Surveillance Study on the Safety, Tolerability and Efficacy of Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01826370
Acronym / sponsor ID: 1218.94
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Terminated
Enrolment: 678 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 8 Apr 2013 (estimated)
Results: Posted 18 Sep 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
Linagliptin	–	Drug: Linagliptin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Filipino type 2 DM patients

Key inclusion criteria (6 listed)

Filipino of Asian race
Patient using Linagliptin within label or locally approved indication. The prescription of Linagliptin to the patient must be in the course of normal clinical practice and independent of the decision to include the patient in the study.
Male or female patients more than 18 years old
Body mass index less than or equal to 40
Diagnosed with type 2 DM

Key exclusion criteria (7 listed)

Diagnosed with type 1 DM
Patients with acute illness requiring hospitalization in the past one month
Patients participating in a different study that includes an investigational drug
Patients with known hypersensitivity reaction to Linagliptin or any of tis components
Pregnant women and those women who have intentions of getting pregnant within the study duration

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
Linagliptintablet	Drug	Linagliptin

Primary outcome

Frequency of Adverse Events and Serious Adverse Events
Time frame: Week 24
Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.

2 secondary outcomes

Change From Baseline to Week 24 of HbA1c
Time frame: Baseline and 24 weeks
Change From Baseline to Week 24 of Fasting Blood Sugar
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 18 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Linagliptin	678	658

Primary outcome: Frequency of Adverse Events and Serious Adverse Events

Time frame: Week 24. Number. Unit: percentage of participants

Measure	Linagliptin n = 660
Adverse Events	0.8
Serious Adverse Events	0.0

Population analysed: Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linagliptin	0 of 660 (0%)	0 of 660 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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

51 sites 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 51 sites in Philippines.

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 7 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Philippines. 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 18 Sep 2014). 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?

Frequency of Adverse Events and Serious Adverse Events (time frame: Week 24). 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 NCT01826370.

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 18 Sep 2014.