Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01826370

Last Updated: 2014-09-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

678 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Linagliptin

Linagliptin

Intervention Type DRUG

tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Linagliptin

tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Filipino of Asian race
2. 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.
3. Male or female patients more than 18 years old
4. Body mass index less than or equal to 40
5. Diagnosed with type 2 DM
6. Uncontrolled type 2 DM with fasting blood sugar of more than 126 mg/dl and/or HbA1c more than 7%.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boehringer Ingelheim Investigational Site 43

Agoo, La Union, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 40

Angeles City, Pampanga, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 31

Angono, Rizal, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 32

Antipolo, Rizal, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 27

Aparri, Cagayan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 4

Batangas, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 48

Butuan City, Agusan Del Norte, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 12

Cabanatuan, Nueva Ecija, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 23

Cagayan de Oro, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 3

Caloocan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 42

Cardona, Rizal, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 25

Cebu, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 44

Dagupan, Pangasinan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 49

Iligan City, Lanao Del Norte, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 2

Iloilo City, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 45

Iriga City, Camarines Sur, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 20

Laoag, Ilocos Norte, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 24

Las Piñas, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 7

Legazpi, Albay, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 35

Lucena, Quezon, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 1

Makati, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 39

Malolos, Bulacan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 37

Mandaluyong, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 28

Manila, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 5

Marikina City, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 16

Meycauyan, Bulacan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 47

Naga City, Camarines Sur, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 15

Olongapo City, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 10

Pampanga, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 19

Paranaque City, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 51

Pasay, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 30

Pasig, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 34

Puerto Princesa, Palawan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 26

Quezon City, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 11

Rosales, Pangasinan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 21

San Fernando, La Union, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 9

San Fernando, Pampanga, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 13

San Jose, Nueva Ecija, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 29

San Juan City, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 8

San Pablo, Laguna, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 50

San Pedro, Laguna, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 41

Santiago City, Isabela, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 36

Sogod, Southern Leyte, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 38

Sta.Maria, Bulacan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 6

Tacloban City, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 33

Tagbilaran, Bohol, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 14

Tuguegarao, Cagayan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 18

Urdaneta, Pangasinan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 46

Valencia City Bukidnon, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 17

Valenzuela, Bulacan, , Philippines

Site Status

Boehringer Ingelheim Investigational Site 22

Zamboanga City, , Philippines

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Philippines

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1218.94

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.