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NCT01826370 Clinical Trial

Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01826370
Other study ID # 1218.94
Secondary ID
Status Terminated
Phase N/A
First received April 4, 2013
Last updated September 17, 2014
Start date May 2012
Est. completion date October 2013

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Terminated
Enrollment 678
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Linagliptin
tablet

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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Change From Baseline to Week 24 of HbA1c Change from baseline to week 24 of glycosylated hemoglobin (HbA1c) Baseline and 24 weeks No
Secondary Change From Baseline to Week 24 of Fasting Blood Sugar Change from baseline to week 24 of fasting blood sugar Baseline and 24 weeks No
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