Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

NCT01826370 | Terminated Results

• 1 other identifier: 1218.94
• Study Type: observational
• Target: 678
• Locations: 1 country
• Sites: 51

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events and Serious Adverse Events

  Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.

  Week 24

Secondary Outcomes (2)

• Change From Baseline to Week 24 of HbA1c

  Baseline and 24 weeks

• Change From Baseline to Week 24 of Fasting Blood Sugar

  Baseline and 24 weeks

Study Arms (1)

Linagliptin

Drug: Linagliptin

Interventions

Linagliptin DRUG

tablet

Linagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Filipino type 2 DM patients

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (51)

Boehringer Ingelheim Investigational Site 43

Agoo, La Union, Philippines

Location

Boehringer Ingelheim Investigational Site 40

Angeles City, Pampanga, Philippines

Location

Boehringer Ingelheim Investigational Site 31

Angono, Rizal, Philippines

Location

Boehringer Ingelheim Investigational Site 32

Antipolo, Rizal, Philippines

Location

Boehringer Ingelheim Investigational Site 27

Aparri, Cagayan, Philippines

Location

Boehringer Ingelheim Investigational Site 4

Batangas, Philippines

Location

Boehringer Ingelheim Investigational Site 48

Butuan City, Agusan Del Norte, Philippines

Location

Boehringer Ingelheim Investigational Site 12

Cabanatuan, Nueva Ecija, Philippines

Location

Boehringer Ingelheim Investigational Site 23

Cagayan de Oro, Philippines

Location

Boehringer Ingelheim Investigational Site 3

Caloocan, Philippines

Location

Boehringer Ingelheim Investigational Site 42

Cardona, Rizal, Philippines

Location

Boehringer Ingelheim Investigational Site 25

Cebu, Philippines

Location

Boehringer Ingelheim Investigational Site 44

Dagupan, Pangasinan, Philippines

Location

Boehringer Ingelheim Investigational Site 49

Iligan City, Lanao Del Norte, Philippines

Location

Boehringer Ingelheim Investigational Site 2

Iloilo City, Philippines

Location

Boehringer Ingelheim Investigational Site 45

Iriga City, Camarines Sur, Philippines

Location

Boehringer Ingelheim Investigational Site 20

Laoag, Ilocos Norte, Philippines

Location

Boehringer Ingelheim Investigational Site 24

Las Piñas, Philippines

Location

Boehringer Ingelheim Investigational Site 7

Legazpi, Albay, Philippines

Location

Boehringer Ingelheim Investigational Site 35

Lucena, Quezon, Philippines

Location

Boehringer Ingelheim Investigational Site 1

Makati, Philippines

Location

Boehringer Ingelheim Investigational Site 39

Malolos, Bulacan, Philippines

Location

Boehringer Ingelheim Investigational Site 37

Mandaluyong, Philippines

Location

Boehringer Ingelheim Investigational Site 28

Manila, Philippines

Location

Boehringer Ingelheim Investigational Site 5

Marikina City, Philippines

Location

Boehringer Ingelheim Investigational Site 16

Meycauyan, Bulacan, Philippines

Location

Boehringer Ingelheim Investigational Site 47

Naga City, Camarines Sur, Philippines

Location

Boehringer Ingelheim Investigational Site 15

Olongapo City, Philippines

Location

Boehringer Ingelheim Investigational Site 10

Pampanga, Philippines

Location

Boehringer Ingelheim Investigational Site 19

Paranaque City, Philippines

Location

Boehringer Ingelheim Investigational Site 51

Pasay, Philippines

Location

Boehringer Ingelheim Investigational Site 30

Pasig, Philippines

Location

Boehringer Ingelheim Investigational Site 34

Puerto Princesa, Palawan, Philippines

Location

Boehringer Ingelheim Investigational Site 26

Quezon City, Philippines

Location

Boehringer Ingelheim Investigational Site 11

Rosales, Pangasinan, Philippines

Location

Boehringer Ingelheim Investigational Site 21

San Fernando, La Union, Philippines

Location

Boehringer Ingelheim Investigational Site 9

San Fernando, Pampanga, Philippines

Location

Boehringer Ingelheim Investigational Site 13

San Jose, Nueva Ecija, Philippines

Location

Boehringer Ingelheim Investigational Site 29

San Juan City, Philippines

Location

Boehringer Ingelheim Investigational Site 8

San Pablo, Laguna, Philippines

Location

Boehringer Ingelheim Investigational Site 50

San Pedro, Laguna, Philippines

Location

Boehringer Ingelheim Investigational Site 41

Santiago City, Isabela, Philippines

Location

Boehringer Ingelheim Investigational Site 36

Sogod, Southern Leyte, Philippines

Location

Boehringer Ingelheim Investigational Site 38

Sta.Maria, Bulacan, Philippines

Location

Boehringer Ingelheim Investigational Site 6

Tacloban City, Philippines

Location

Boehringer Ingelheim Investigational Site 33

Tagbilaran, Bohol, Philippines

Location

Boehringer Ingelheim Investigational Site 14

Tuguegarao, Cagayan, Philippines

Location

Boehringer Ingelheim Investigational Site 18

Urdaneta, Pangasinan, Philippines

Location

Boehringer Ingelheim Investigational Site 46

Valencia City Bukidnon, Philippines

Location

Boehringer Ingelheim Investigational Site 17

Valenzuela, Bulacan, Philippines

Location

Boehringer Ingelheim Investigational Site 22

Zamboanga City, Philippines

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 8, 2013
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 18, 2014
• Results First Posted: September 18, 2014

Record last verified: 2014-09

Locations

PH (51)