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

  Show 51 Study Locations
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, Type 2
Diabetes Mellitus
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 September 22, 2014