Study Metrics
Total Sample
96
Treatment Group
48
Control Group
48
Covariates
4
PICO Comparisons
3
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Wakabayashi |
| Publication Year: | 2023 |
| DOI: | https://doi.org/10.1007/s40801-023-00353-7 |
| Preprint: | No preprint |
Institution & Funding
| Institutions: | linical Study Support, Inc., Nagoya, Japan, Real-World Evidence and Data Assessment (READS), Graduate School of Medicine, Juntendo University, Department of Radiology, School of Medicine, Juntendo University |
| Funding: | Declared: Research institute, private |
| Funding Institutions: | This study was conducted as part of a joint research course (Real-World Evidence and Data Assessment) between Juntendo University and Shin Nippon Biomedical Laboratories, Ltd. |
Study Context
| Disease: | Diabetes |
| Disease Category: | Endocrinology |
| Data Type: | Other |
| Number of Data Sources: | 1 |
| Geography: | Japan |
| Eligible Sample: | 96.0 |
Analytical Methods
| Matching Method: | 1:1 PS nearest-neighbor matching |
| Analysis Method: | t-distribution |
| Estimand: | ITT |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | PRIME-V |
| Registration Number: | UMIN000015170 |
| Target Trial DOI: | https://doi.org/10.1111/dom.13750 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
Change in HbA1c, %
COMPASS
MD
Efficacy
Population
Japanese adults with T2D inadequately controlled with metformin and/or sulfonylurea
Intervention
Sitagliptin
Comparison
Pioglitazone
Outcome
Change in HbA1c, %
RCT Result
-0.28
95% CI: [-0.14, -0.16]
vs
TTE Result
-0.01
95% CI: [-0.25, 0.23]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Same Direction
Both point to similar conclusion
Both point to similar conclusion
Change in HbA1c, %
Onishi 2013 et al.
MD
Efficacy
Population
Insulin-naïve Japanese adults with T2D
Intervention
Insulin degludec/insulin aspart
Comparison
Insulin glargine
Outcome
Change in HbA1c, %
RCT Result
-0.28
95% CI: [-0.46, -0.10]
vs
TTE Result
0.46
95% CI: [-0.01, 0.94]
Concordance Assessment
Confidence Interval Overlap:
No
CIs do not overlap
CIs do not overlap
Direction Agreement:
Different Direction
Different conclusions
Different conclusions
Percentage changes in HbA1c levels (%)
PRIME-V
MD
Efficacy
Population
Japanese adults with T2D treated with sitagliptin
Intervention
Ipragliflozin
Comparison
Metformin
Outcome
Percentage changes in HbA1c levels (%)
RCT Result
4.03
95% CI: [0.79, 7.27]
vs
TTE Result
-6.21
95% CI: [-11.01, -1.40]
Concordance Assessment
Confidence Interval Overlap:
No
CIs do not overlap
CIs do not overlap
Direction Agreement:
Different Direction
Different conclusions
Different conclusions
Transparency Indicators
Protocol Registration
Available
Data Sharing
Not Available
Code Sharing
Not Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.
Conflicts & Funding
| Conflicts of Interest: | Declared: Financial |
| COI Institutions: | Clinical Study Support Inc. |
| Funding Source: | Declared: Research institute, private |
| Funding Institutions: | This study was conducted as part of a joint research course (Real-World Evidence and Data Assessment) between Juntendo University and Shin Nippon Biomedical Laboratories, Ltd. |