Introduction
Study methods
Trial design
Randomisation
Sample size
Trial framework
Statistical interim analysis
Timing of final analysis
Statistical principles
Confidence intervals and significance level
Adherence and protocol deviations
Definition of adherence
Presentation of adherence
Visit numbera | Treatment group | |
---|---|---|
GKT137831 N (%) | Placebo, N (%) | |
4 | ||
5 | ||
6 | ||
7 | ||
8 | ||
9 | ||
10 |
Definition of protocol deviations
Presentation of protocol deviations
Analysis populations
Main analysis set (ITT analysis set)
Modified intention-to-treat analysis set
Safety analysis set
Per protocol (PP) analysis set
Trial population
Screen data
Eligibility criteria
Recruitment
Withdrawals/follow up
Baseline participant characteristics
Baseline characteristic | Intervention (GKT137831) group (n = xxx) | Placebo group (n = xxx) | Percentage standardised difference | Overall (n = xxx) | |||
---|---|---|---|---|---|---|---|
Values | Missing, n (%) | Values | Missing, n (%) | Values | Missing, n (%) | ||
Urine albumin–creatinine ratio (UACR) (log-transformed) | |||||||
Mean (standard deviation (SD)) | |||||||
Estimated glomerular filtration rate (eGFR) (log-transformed) | |||||||
Mean (SD) | |||||||
Gender | |||||||
Male, n (%) | |||||||
Female, n (%) | |||||||
Age (years), | |||||||
Mean (SD) | |||||||
Ethnicity | |||||||
xx, n (%) | |||||||
Other, n (%) | |||||||
Clinical variables | |||||||
Systolic blood pressure (mmHg), mean (SD) | |||||||
Diastolic blood pressure (mmHg), mean (SD) | |||||||
Use of angiotensin-converting-enzyme inhibitor (ACEi), n (%) | |||||||
Use of angiotensin II receptor blocker (ARB), n (%) | |||||||
Body mass index (kg/m2), mean (SD) | |||||||
Duration of diabetes mellitus at baseline (years), mean (SD) | |||||||
Glycated haemoglobin (HbA1c %), median (25th–75th percentile) |
Analysis
Outcome definitions
Primary outcome measure
Secondary outcome measures
Exploratory outcome measures
Safety outcome measures
Hypotheses
Primary hypothesis
Secondary hypotheses
Exploratory concepts
Safety objectives
Analysis methods
Primary analyses
Outcome | Analysis | Mean (standard deviation) | Estimated mean differencea | 95% Confidence Interval | P value | ||
---|---|---|---|---|---|---|---|
Intervention (GKT137831) group (n = xxx) | Placebo group (n = xxx) | ||||||
Primary | Endpoint UACR | Intention to treat (ITT) | |||||
modified ITT | |||||||
Per protocol (PP) | |||||||
Secondary | Midpoint UACR | Intention to treat (ITT) | |||||
modified ITT | |||||||
Per protocol (PP) | |||||||
Endpoint eGFR | Intention to treat (ITT) | ||||||
modified ITT | |||||||
Per protocol (PP) | |||||||
Midpoint eGFR | Intention to treat (ITT) | ||||||
modified ITT | |||||||
Per protocol (PP) |
Subgroup | Number (%) | Estimated mean differencea | 95% Confidence Interval | P value | |
---|---|---|---|---|---|
Intervention (GKT137831) group (n = xxx) | Placebo group (n = xxx) | ||||
Sex | |||||
Male | |||||
Female | |||||
Age | |||||
< median | |||||
≥ median | |||||
Diabetes mellitus duration | |||||
< median | |||||
≥ median | |||||
BMI | |||||
< median | |||||
≥ median | |||||
HbA1c | |||||
< median | |||||
≥ median |
Secondary analyses
Exploratory analyses
Safety analyses
Safety outcome measure | Values | Percentage standardized difference | Estimated differencea | 95% Confidence Intervala | P valuea | |
---|---|---|---|---|---|---|
Intervention (GKT137831) group (n = xxx) | Placebo group (n = xxx) | |||||
Treatment-emergent adverse events, n (%) | ||||||
Abnormal laboratory analytes, n (%) | ||||||
Abnormal physical examination and vital signs, n (%) | ||||||
QT corrected electrocardiogram (ECG), mean (SD) | ||||||
Treatment-emergent qualitative ECG, n (%) | ||||||
Concomitant medications, n (%) | ||||||
Systolic blood pressure (mmHg), mean (SD) | ||||||
Diastolic blood pressure (mmHg), mean (SD) | ||||||
Heart rate (beats per minute), mean (SD) | ||||||
Weight (Kg), mean (SD) |