Clinical trial NCT01826370: Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus
Official title: A Post-Marketing Surveillance Study on the Safety, Tolerability and Efficacy of Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Filipino type 2 DM patients

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Adverse Events and Serious Adverse Events
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline to Week 24 of HbA1c
timeFrame: Baseline and 24 weeks
measure: Change From Baseline to Week 24 of Fasting Blood Sugar
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Agoo, La Union
country: Philippines
facility: Boehringer Ingelheim Investigational Site 43
city: Angeles City, Pampanga
country: Philippines
facility: Boehringer Ingelheim Investigational Site 40
city: Angono, Rizal
country: Philippines
facility: Boehringer Ingelheim Investigational Site 31
city: Antipolo, Rizal
country: Philippines
facility: Boehringer Ingelheim Investigational Site 32
city: Aparri, Cagayan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 27
city: Batangas
country: Philippines
facility: Boehringer Ingelheim Investigational Site 4
city: Butuan City, Agusan del Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site 48
city: Cabanatuan, Nueva Ecija
country: Philippines
facility: Boehringer Ingelheim Investigational Site 12
city: Cagayan de Oro
country: Philippines
facility: Boehringer Ingelheim Investigational Site 23
city: Caloocan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 3
city: Cardona, Rizal
country: Philippines
facility: Boehringer Ingelheim Investigational Site 42
city: Cebu
country: Philippines
facility: Boehringer Ingelheim Investigational Site 25
city: Dagupan, Pangasinan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 44
city: Iligan City, Lanao del Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site 49
city: Iloilo
country: Philippines
facility: Boehringer Ingelheim Investigational Site 2
city: Iriga City, Camarines Sur
country: Philippines
facility: Boehringer Ingelheim Investigational Site 45
city: Laoag, Ilocos Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site 20
city: Las Pinas
country: Philippines
facility: Boehringer Ingelheim Investigational Site 24
city: Legazpi, Albay
country: Philippines
facility: Boehringer Ingelheim Investigational Site 7
city: Lucena, Quezon
country: Philippines
facility: Boehringer Ingelheim Investigational Site 35
city: Makati
country: Philippines
facility: Boehringer Ingelheim Investigational Site 1
city: Malolos, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 39
city: Mandaluyong City
country: Philippines
facility: Boehringer Ingelheim Investigational Site 37
city: Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site 28
city: Marikina
country: Philippines
facility: Boehringer Ingelheim Investigational Site 5
city: Meycauyan, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 16
city: Naga City, Camarines Sur
country: Philippines
facility: Boehringer Ingelheim Investigational Site 47
city: Olongapo
country: Philippines
facility: Boehringer Ingelheim Investigational Site 15
city: Pampanga
country: Philippines
facility: Boehringer Ingelheim Investigational Site 10
city: Paranaque
country: Philippines
facility: Boehringer Ingelheim Investigational Site 19
city: Pasay City
country: Philippines
facility: Boehringer Ingelheim Investigational Site 51
city: Pasig
country: Philippines
facility: Boehringer Ingelheim Investigational Site 30
city: Puerto Princesa, Palawan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 34
city: Quezon City
country: Philippines
facility: Boehringer Ingelheim Investigational Site 26
city: Rosales, Pangasinan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 11
city: San Fernando, La Union
country: Philippines
facility: Boehringer Ingelheim Investigational Site 21
city: San Fernando, Pampanga
country: Philippines
facility: Boehringer Ingelheim Investigational Site 9
city: San Jose, Nueva Ecija
country: Philippines
facility: Boehringer Ingelheim Investigational Site 13
city: San Juan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 29
city: San Pablo, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site 8
city: San Pedro, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site 50
city: Santiago city, Isabela
country: Philippines
facility: Boehringer Ingelheim Investigational Site 41
city: Sogod, Southern Leyte
country: Philippines
facility: Boehringer Ingelheim Investigational Site 36
city: Sta.Maria, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 38
city: Tacloban
country: Philippines
facility: Boehringer Ingelheim Investigational Site 6
city: Tagbilaran, Bohol
country: Philippines
facility: Boehringer Ingelheim Investigational Site 33
city: Tuguegarao, Cagayan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 14
city: Urdaneta, Pangasinan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 18
city: Valencia City Bukidnon
country: Philippines
facility: Boehringer Ingelheim Investigational Site 46
city: Valenzuela, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site 17
city: Zamboanga
country: Philippines
facility: Boehringer Ingelheim Investigational Site 22
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: