Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01826370
First received: April 4, 2013
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Linagliptin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-Marketing Surveillance Study on the Safety, Tolerability and Efficacy of Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Frequency of Adverse Events and Serious Adverse Events [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.


Secondary Outcome Measures:
  • Change From Baseline to Week 24 of HbA1c [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)

  • Change From Baseline to Week 24 of Fasting Blood Sugar [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline to week 24 of fasting blood sugar


Enrollment: 678
Study Start Date: May 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Linagliptin Drug: Linagliptin
tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Filipino type 2 DM patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826370

  Hide Study Locations
Locations
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, Philippines
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01826370     History of Changes
Other Study ID Numbers: 1218.94
Study First Received: April 4, 2013
Results First Received: September 10, 2014
Last Updated: September 17, 2014
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014