Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01650259
First received: July 24, 2012
Last updated: February 4, 2015
Last verified: February 2015
| Tracking Information | |||||
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| First Received Date ICMJE | July 24, 2012 | ||||
| Last Updated Date | February 4, 2015 | ||||
| Start Date ICMJE | July 2012 | ||||
| Estimated Primary Completion Date | July 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01650259 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The change from the baseline in HbA1c to the last-observation on treatment [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus | ||||
| Official Title ICMJE | 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). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* 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 ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 3300 | ||||
| Estimated Completion Date | July 2017 | ||||
| Estimated Primary Completion Date | July 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria: None |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Japan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01650259 | ||||
| Other Study ID Numbers ICMJE | 1218.95 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Boehringer Ingelheim | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim | ||||
| Collaborators ICMJE | Eli Lilly and Company | ||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim | ||||
| Verification Date | February 2015 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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