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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

April 4, 2013
September 17, 2014
May 2012
October 2013   (final data collection date for primary outcome measure)
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.
Safety endpoints are frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events. [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01826370 on ClinicalTrials.gov Archive Site
  • 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
  • Change from baseline to endpoint of glycosylated hemoglobin [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint of fasting blood sugar [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Filipino type 2 DM patients

Diabetes Mellitus, Type 2
Drug: Linagliptin
tablet
Linagliptin
Intervention: Drug: Linagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
678
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01826370
1218.94
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP