Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Linagliptin

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