Type II Diabetes Mellitus Clinical Trial
Official title:
Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan- for Dapagliflozin in Management of Type 2 Diabetes Mellitus
REWARD is an Non Interventional study aims to describe the changes in the clinical outcomes of Type 2 Diabetes Mellitus patients who are treated with Dapagliflozin for a period of one year including the fasting period of Ramadan
REWARD is a multi-center, post-authorization, prospective, open label, non-interventional,
real-life, observational, cohort study. The study is to be conducted at 10-15 sites .
Aims to describe the changes in the clinical outcomes over 1 year as follows:
1. Primary Objective:
To describe the change in HbAlc from baseline as a parameter for blood glucose control.
2. Secondary Objective:
To describe the changes from baseline in the following parameters:
- Total body weight.
- Total cholesterol, LDL-C, non-HDL-C and triglycerides.
- Systolic and Diastolic Blood Pressures.
3. Other Objective:
To capture the frequency & incidence of the following reported adverse events :
- Hypoglycemic episodes.
- Volume Depletion.
- Genital infections.
- Urinary tract infections.
4. Exploratory Objective:
To describe the combined effect of the hot climate season and fasting Ramadan on the level of
total ketone bodies levels in T2DM subjects treated with Dapagliflozin.Description of outcome
variables in relation to objectives and hypotheses
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