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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: OAD; Drug: Trazenta

• Registration Number: NCT01650259
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2012-07-23
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-26
• Primary Completion: 2017-09-05
• Study Completion: 2017-09-14
• Results First Submitted: 2018-08-20
• Results First Submitted QC: 2019-02-08
• Results First Posted: 2019-05-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4876

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral antidiabetic drug (OAD)	OAD	-
Trazenta	Trazenta	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Drug Reactions (ADRs)	From start of the treatment until the end of this PMS, i.e. up to week 156	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".

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at the Last Observation During the Observation Period.	Baseline and 156 week or last observation	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).