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

Tracking Information
First Submitted Date	July 24, 2012
First Posted Date	July 26, 2012
Last Update Posted Date	November 7, 2017
Actual Study Start Date	July 23, 2012
Actual Primary Completion Date	September 5, 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 13, 2013)	Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01650259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: November 13, 2013)	The change from the baseline in HbA1c to the last-observation on treatment [ Time Frame: up to 156 weeks ]
Original Secondary Outcome Measures; (submitted: July 24, 2012)	The change between baseline and observation period in HbA1c [ Time Frame: up to 156 weeks ]; Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ]; Incidence of serious adverse events (SAEs) [ Time Frame: up to 156 weeks ]; Incidence of cardiovascular events [ Time Frame: up to 156 weeks ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Official Title	Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Brief Summary	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).
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	3300
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: OAD OAD except Trazenta tablets; Drug: Trazenta Linagliptin
Study Groups/Cohorts	Oral antidiabetic drug (OAD) Intervention: Drug: OAD; Trazenta Intervention: Drug: Trazenta
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: November 6, 2017)	4876
Original Estimated Enrollment; (submitted: July 24, 2012)	6600
Actual Study Completion Date	September 5, 2017
Actual Primary Completion Date	September 5, 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria	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:
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Germany
Removed Location Countries	Japan
Administrative Information
NCT Number	NCT01650259
Other Study ID Numbers	1218.95
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Boehringer Ingelheim
Study Sponsor	Boehringer Ingelheim
Collaborators	Eli Lilly and Company
Investigators	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account	Boehringer Ingelheim
Verification Date	November 2017