Status:
TERMINATED
Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
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 w...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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%.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
678 Patients enrolled
Trial Details
Trial ID
NCT01826370
Start Date
May 1 2012
End Date
October 1 2013
Last Update
September 18 2014
Active Locations (51)
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1
Boehringer Ingelheim Investigational Site 43
Agoo, La Union, Philippines
2
Boehringer Ingelheim Investigational Site 40
Angeles City, Pampanga, Philippines
3
Boehringer Ingelheim Investigational Site 31
Angono, Rizal, Philippines
4
Boehringer Ingelheim Investigational Site 32
Antipolo, Rizal, Philippines