Title: Treatment preference for weekly DPP-4 inhibitors versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus < TRINITY > NCT Number: NCT03231709 Statistical analysis plan Approve Date: 15-Mar-2018 Certain information within this statistical analysis plan has been redacted (ie, specific content is masked irreversibly from view with a black/blue bar) to protect either personally identifiable information or company confidential information. This may include, but is not limited to, redaction of the following: Named persons or organizations associated with the study. Patient identifiers within the text, tables, or figures or in by-patient data listings. Proprietary information, such as scales or coding systems, which are considered confidential information under prior agreements with license holder. Other information as needed to protect confidentiality of Takeda or partners, personal information, or to otherwise protect the integrity of the clinical study. If needed, certain appendices that contain a large volume of personally identifiable information or company confidential information may be removed in their entirety if it is considered that they do not add substantially to the interpretation of the data (eg, appendix of investigator’s curriculum vitae). Note; This document was translated into English as the language on original version was Japanese.
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NCT Number: NCT03231709 - clinicaltrials.gov · 3 . The 16th week (Week 16) of the treatment period in the following analysis is handled as the visit of 8 weeks after start of administration
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Title: Treatment preference for weekly DPP-4 inhibitors versus daily DPP-4 inhibitors
in patients with type 2 diabetes mellitus < TRINITY >
NCT Number: NCT03231709
Statistical analysis plan Approve Date: 15-Mar-2018
Certain information within this statistical analysis plan has been redacted (ie, specific
content is masked irreversibly from view with a black/blue bar) to protect either
personally identifiable information or company confidential information.
This may include, but is not limited to, redaction of the following:
Named persons or organizations associated with the study.
Patient identifiers within the text, tables, or figures or in by-patient data listings.
Proprietary information, such as scales or coding systems, which are considered
confidential information under prior agreements with license holder.
Other information as needed to protect confidentiality of Takeda or partners,
personal information, or to otherwise protect the integrity of the clinical study.
If needed, certain appendices that contain a large volume of personally identifiable
information or company confidential information may be removed in their entirety if it
is considered that they do not add substantially to the interpretation of the data (eg,
appendix of investigator’s curriculum vitae).
Note; This document was translated into English as the language on original version
was Japanese.
Treatment preference for weekly DPP-4 inhibitors versus daily DPP-4 inhibitors
in patients with type 2 diabetes mellitus (TRINITY)
(Protocol number: Trelagliptin-4003)
Statistical Analysis Plan(Ver.2.0: 15 Mar 2018)
Sponsor: Takeda Pharmaceutical Company Limited
Authorizer:
Takeda Pharmaceutical Company Limited
Biostatistics Manager: PPD
PPD
PPD
TABLE of CONTENTS
1. DEFINITIONS of TERMS ................................................................................................. 1 2. ANALYSIS SET ................................................................................................................ 1 3. CONSIDERATIONS on STATISTICAL ANALYSIS ........................................................... 1
3.1. Adjustments for Covariates .............................................................................................. 1 3.2. Handling of Dropouts or Missing Data.............................................................................. 1 3.3. Criteria for Interim Analysis and Early Stopping ............................................................... 1 3.4. Multicenter Study............................................................................................................ 1 3.5. Multiple Comparisons/Multiplicity ................................................................................... 1 3.6. Examination of Subgroups ............................................................................................... 1 3.7. Considerations for Creating Analysis Results .................................................................... 2 3.8. Time Window ................................................................................................................. 2
4. SUBJECTS, DEMOGRAPHIC and OTHER BASELINE CHARACTERISTICS ................... 3 4.1. Subject Disposition ......................................................................................................... 3 4.2. Demographics and Other Baseline Characteristics ............................................................. 5
5. EFFICACY EVALUATIONS ............................................................................................. 7 5.1. Primary Endpoint and the Analytical Methods ................................................................... 7 5.2. Secondary Endpoints and the Analytical Methods .............................................................. 8 5.3. Other Endpoints and the Analytical Methods ..................................................................... 8
6. SAFETY EVALUATION ................................................................................................... 9 6.1. Brief Summary of Adverse Events (TEAE) ....................................................................... 9 6.2. Display of TEAE .......................................................................................................... 10