Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim

Status: Terminated

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Linagliptin

Study type: Observational

Funder types: Industry

Identifiers

NCT01826370

1218.94

Details and patient eligibility

About

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.

Enrollment: 678 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

678 participants in 1 patient group

Linagliptin

Treatment:

Drug: Linagliptin