Here is the design of a clinical trial:

Official Title: Effectiveness and Tolerability of Novel, Initial Triple Combination Therapy With Xigduo (Dapagliflozin Plus Metformin) and Saxagliptin vs. Conventional Stepwise add-on Therapy in Drug-naïve Patients With Type 2 Diabetes

Included conditions:
- Diabetes Mellitus, Type II

Study Armgroups:
- {'label': 'Triple combination therapy group', 'type': 'EXPERIMENTAL', 'description': 'Xigduo (metformin 1000mg + dapagliflozin 10mg), saxagliptin 5mg once daily for 104 weeks', 'interventionNames': ['Drug: triple combination therapy']}
- {'label': 'Stepwise add-on therapy group', 'type': 'ACTIVE_COMPARATOR', 'description': '* Participants were started on metformin 1000mg once daily after screening \\& assignment\n* At each visits, FPG and HbA1c are measured. Sequential add-on therapy regimen is described', 'interventionNames': ['Drug: Stepwise add-on therapy']}

Interventions:
- {'type': 'DRUG', 'name': 'triple combination therapy', 'description': 'Xigduo (metformin 1000mg + dapagliflozin 10mg) saxagliptin 5mg', 'armGroupLabels': ['Triple combination therapy group'], 'otherNames': ['metformin 1000mg', 'dapagliflozin 10mg', 'saxagliptin 5mg']}
- {'type': 'DRUG', 'name': 'Stepwise add-on therapy', 'description': 'metformin -\\> glimepirde -\\> sitagliptin', 'armGroupLabels': ['Stepwise add-on therapy group'], 'otherNames': ['Metformin', 'Glimepiride', 'Sitagliptin']}

Primary Outcomes:
- {'measure': 'Proportion of patients who met HbA1c < 6.5% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 104 weeks', 'timeFrame': '104 weeks'}

Please estimate the sample size based on the assumption: 
The study aims for 90% power to detect a 60% difference in tolerability and a 30% increase in HbA1c target goal achievement rate, with a two-sided 5% level of significance. Additionally, a 10% dropout rate is assumed.
Sample size calculation
        The tolerability will be measured using a composite endpoint with no hypoglycaemia, no weight gain or discontinuation due to a safety concern. It is assumed that the initial triple combination therapy will show a total of at most 10% intolerability (5% for hypoglycaemia, 0% for weight gaining or 5% for discontinuation due to AEs), while the stepwise add-on therapy will show a total of at most 70% intolerability (20% for hypoglycaemia, 30% for weight gaining or 20% for discontinuation due to AEs). A total of 10 subjects per group provided 90% power to detect a difference of 60% tolerability decrease (90% vs 30%) for the initial triple combination therapy compared with the stepwise add-on therapy with a two-sided 5% level of significance.
        To compare the efficacy of therapies, we assume that half of the subjects who are tolerable to the therapies will reach the target HbA1c level. A total of 46 subjects per group, then, are needed to provide 90% power in order to detect a 30% (45% vs 15%) increase in HbA1c target goal achievement rate of the initial triple combination therapy compared with the stepwise add-on therapy with a two-sided 5% level of significance based on normal approximation with unpooled variance.
        Assuming that about 10% of subjects would be lost to follow-up during study periods, we aim to recruit 52 subjects per group (104 subjects in total) for this study.