We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01826370
First Posted: April 8, 2013
Last Update Posted: September 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
April 4, 2013
April 8, 2013
September 10, 2014
September 18, 2014
September 18, 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 ]
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 ]
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 ]
    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 ]
    Change from baseline to week 24 of fasting blood sugar
  • Change from baseline to endpoint of glycosylated hemoglobin [ Time Frame: Up to 24 weeks ]
  • Change from baseline to endpoint of fasting blood sugar [ Time Frame: Up to 24 weeks ]
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
 
NCT01826370
1218.94
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2014