Tables, Listings & Figures (TLF) Shells — GLPI103-301
| Field |
Value |
| Document ID |
TLF-301 |
| Version |
1.0 |
| Study No. |
GLPI103-301 |
| Standard |
ICH E3; CSR-aligned shells |
| Confidentiality |
Confidential |
Shell mock-ups for the planned TLFs; each maps to a generated artifact (outputs/). Columns are the three arms (IV / Oral / Semaglutide).
Change History
| Version |
Date |
Author |
Summary |
| 1.0 |
2026-06-29 |
Biostatistics |
Initial shells |
Tables
| Table |
Title |
Population |
Source |
| 14.1.1 |
Subject disposition |
All randomized |
Figure 1 / ADSL |
| 14.1.2 |
Protocol deviations |
FAS |
QA-DEV |
| 14.1.3 |
Demographics & baseline characteristics |
FAS |
table1_demographics.xlsx |
| 14.2.1 |
Exposure & compliance |
Safety |
ADSL/EX |
| 14.2.2 |
Primary efficacy — HbA1c CFB at Week 52 (ANCOVA LS means & contrasts) |
FAS |
table2_primary_efficacy.xlsx, ancova_results.csv |
| 14.2.3 |
Longitudinal HbA1c (MMRM) by visit |
FAS |
mmrm_results.csv / Figure 2 |
| 14.2.4 |
Secondary — weight CFB, FPG CFB |
FAS |
ADLB/EDC |
| 14.2.5 |
Responders — HbA1c <7.0%, ≥10% weight loss |
FAS |
ADLB |
| 14.3.1 |
TEAE overview & by SOC/PT |
Safety |
table3_teae_summary.xlsx |
| 14.3.2 |
AESI & hypoglycaemia |
Safety |
AE |
| 14.3.3 |
Laboratory shift tables; vital-sign CFB |
Safety |
ADLB/ADVS |
Shell — Table 14.2.2 (Primary, ANCOVA)
Endpoint: Change from baseline in HbA1c (%) at Week 52 — FAS
GLPI-103 IV GLPI-103 Oral Semaglutide
N xxx xxx xxx
Baseline mean (SD) x.x (x.x) x.x (x.x) x.x (x.x)
LS mean CFB (95% CI) -x.xx (..,..) -x.xx (..,..) -x.xx (..,..)
Difference vs Sema -0.xx -0.xx ref
95% CI / p-value (..,..) p<.001 (..,..) p<.001 —
Figures
| Figure |
Title |
Source |
| 1 |
CONSORT disposition flow |
figure1_consort.pdf |
| 2 |
Mean HbA1c CFB by visit and arm (MMRM) |
figure2_hba1c_longitudinal.pdf |
| 3 |
Subgroup forest plot (HbA1c effect) |
figure3_forest_plot.pdf |
Listings
| Listing |
Title |
| 16.2.1 |
Subject disposition |
| 16.2.4 |
Protocol deviations |
| 16.2.7 |
Adverse events (by subject) |
| 16.2.8 |
Serious adverse events / deaths |
| 16.2.x |
Laboratory abnormalities |