Question: The research question is whether there is a difference in the efficacy of Study drug A and Study drug B (which is the standard of

The research question is whether there is a difference in the efficacy of Study drug A and Study drug B (which is the standard of care) for the treatment of type 2 diabetes. The investigator has planned a quadruple blind randomized clinical trial to study whether the study drug A is effective in reducing glycosylated hemoglobin (HbA1c) as compared to study drug B (standard of care ) in participants with Type 2 Diabetes after 12 weeks.

A previous study has reported the mean HbA1C level in subjects treated for diabetes is 8 %(% here is a unit of measure)with a standard deviation of2%(% here is a unit of measure).The investigator would like to be able to detect a difference of20%or more in the mean HbA1C levels between the two groups

Please note: HbA1c is measured and expressed in percentage as units and not as a percentage of proportions.

Use a two-sided = 0.05

And power 0.80.

Calculate the sample size

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