Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01650259
First received: July 24, 2012
Last updated: April 2, 2014
Last verified: April 2014

July 24, 2012
April 2, 2014
July 2012
July 2017   (final data collection date for primary outcome measure)
Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01650259 on ClinicalTrials.gov Archive Site
The change from the baseline in HbA1c to the last-observation on treatment [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ]
  • The change between baseline and observation period in HbA1c [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of cardiovascular events [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus

Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).

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

3300

Diabetes Mellitus, Type 2
  • Drug: OAD
    OAD except Trazenta tablets
  • Drug: Trazenta
    Linagliptin
  • Oral antidiabetic drug (OAD)
    Intervention: Drug: OAD
  • Trazenta
    Intervention: Drug: Trazenta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3300
July 2017
July 2017   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Male and female patients with type 2 Diabetes Mellitus who have never been treated with Trazenta tablets / Linagliptin (monotherapy) before enrollment. (Trazenta group)
  • Patients with type 2 Diabetes Mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (OAD)) except Trazenta tablets. (OAD group)

Exclusion criteria:

None

Both
Not Provided
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Japan
 
NCT01650259
1218.95
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

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