Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

September 17, 2014 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

678

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Filipino type 2 DM patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Linagliptin
Drug: Linagliptin
tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events and Serious Adverse Events
Time Frame: Week 24
Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 24 of HbA1c
Time Frame: Baseline and 24 weeks
Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)
Baseline and 24 weeks
Change From Baseline to Week 24 of Fasting Blood Sugar
Time Frame: Baseline and 24 weeks
Change from baseline to week 24 of fasting blood sugar
Baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.94

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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