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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650259
• Other study ID #: 1218.95
• Status: Completed
• Start date: July 23, 2012
• Est. completion date: September 14, 2017

Study information

• Verified date: September 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4876
• Est. completion date: September 14, 2017
• Est. primary completion date: September 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• OAD
OAD except Trazenta tablets
• Trazenta
Linagliptin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Drug Reactions (ADRs)	An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied".	From start of the treatment until the end of this PMS, i.e. up to week 156
Secondary	Change From Baseline in HbA1c at the Last Observation During the Observation Period.	Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD).	Baseline and 156 week or last observation

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