Here is the design of a clinical trial:

Official Title: Effects of SGLT-2 Inhibitor on Myocardial Perfusion, Function and Metabolism in Type 2 DM Patients at High Cardiovascular Risk: The SIMPle Randomized Clinical Trial

Included conditions:
- Type2 Diabetes Mellitus

Study Armgroups:
- {'label': 'Empagliflozin', 'type': 'EXPERIMENTAL', 'description': 'Empagliflozin, coated tablets, 25mg, once daily, for 13 weeks', 'interventionNames': ['Drug: Empagliflozin']}
- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo, coated tablets, once daily, for 13 weeks', 'interventionNames': ['Drug: Placebo Oral Tablet']}

Interventions:
- {'type': 'DRUG', 'name': 'Empagliflozin', 'description': 'Empagliflozin tablet', 'armGroupLabels': ['Empagliflozin'], 'otherNames': ['Jardiance']}
- {'type': 'DRUG', 'name': 'Placebo Oral Tablet', 'description': 'Sugar pill, visually identical to active comparator', 'armGroupLabels': ['Placebo']}

Primary Outcomes:
- {'measure': 'Rb-82 PET', 'description': 'Between group difference in the change in myocardial flow reserve (MFR) by Rb-82 PET. Measured as change in global perfusion from rest to adenosine-induced stress.', 'timeFrame': '13 weeks'}
- {'measure': 'Invasive hemodynamics', 'description': 'Substudy, performed on 38 participants from the main group. Using right heart catheterisation to measure between group difference in the change in pulmonary capillary weight pressure (PCWP) at 25 watts (supine bicycle ergometer)', 'timeFrame': '13 weeks'}

Please estimate the sample size based on the assumption: 
For both endpoints, a power of 80% and a two-sided significance level of 5% are assumed. A 10% drop-out rate is assumed for the primary endpoint, and a 15% drop-out rate is assumed for the substudy key endpoint.
Sample size
        
          Primary endpoint
          The primary endpoint is change in MFR. In a previous study on a comparable population, the SD of measurements of MFR by 82Rb-PET was 0.8. Assuming a clinically relevant difference between the treatment and placebo groups after 6 months of 0.5 in MFR,27 a sample size of 41:41 (empagliflozin: placebo) can be detected with 80% power and a two-sided significance level of 5%. In all, 92 patients will be randomised to allow for a 10% drop-out rate from the ITT population.
        
        
          Substudy key endpoint
          Based on recent experiments in a comparable study population,28 a difference of 5âmm Hg in PCWP during exercise was considered clinically significant. The SD of measurements of PCWP was 5âmm Hg; thus, a sample size of 16:16 is required with a power of 80% and a two-sided significance level of 5% to detect a difference of 5âmm Hg between groups. In total 38 patients will be included in the substudy to allow for a 15% drop-out rate.
          In the ITT population, none of the randomised participants will be excluded, and the patients will be analysed according to the randomisation group. The per-protocol population will consist of all the patients who completed the study with a documented valid baseline and a final-week assessment of the primary objective without any major protocol violations. Analysis of the primary outcome parameter will focus on a change in global MBF from the baseline to week 13 between the treatment and control groups. The primary analysis will be based on the ITT population. The primary outcome measure will be analysed using Analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. The model will include the prespecified covariates age and gender. Missing data will be estimated using the maximum likelihood method. Normally distributed variables will be presented as meanÂ±SD, and non-parametric statistics or appropriate log transformation will be performed if an assumption of normality is not met. After log transformation, the variable will be further tested for normality distribution as indicated. A two-tailed p value of less than 0.05 will be considered statistically significant.
          Comparisons between the treatment groups will be performed by an unpaired two sample t-test, Mann-Whitney test or Ï2 test as appropriate.