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Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01826370
Recruitment Status : Terminated
First Posted : April 8, 2013
Results First Posted : September 18, 2014
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Linagliptin

Study Type : Observational
Actual Enrollment : 678 participants
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
Study Start Date : May 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin
U.S. FDA Resources

Group/Cohort Intervention/treatment
Linagliptin Drug: Linagliptin
tablet



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change From Baseline to Week 24 of HbA1c [ Time Frame: Baseline and 24 weeks ]
    Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826370


  Show 51 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01826370     History of Changes
Other Study ID Numbers: 1218.94
First Posted: April 8, 2013    Key Record Dates
Results First Posted: September 18, 2014
Last Update Posted: September 18, 2014
Last Verified: September 2014

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action