Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01650259 |
Recruitment Status
:
Completed
First Posted
: July 26, 2012
Last Update Posted
: November 7, 2017
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Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
Tracking Information | ||||
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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 |
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 |
The change from the baseline in HbA1c to the last-observation on treatment [ Time Frame: up to 156 weeks ] | |||
Original Secondary Outcome Measures |
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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 |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | 3300 | |||
Condition | Diabetes Mellitus, Type 2 | |||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
4876 | |||
Original Estimated Enrollment |
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:
Exclusion criteria: |
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Sex/Gender |
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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 |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | November 2017 |