NCT02805361

Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan-for Dapagliflozin in Management of Type II Diabetes Mellitus

Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan- for Dapagliflozin in Management of Type 2 Diabetes Mellitus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 511 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Type II Diabetes Mellitus

Timeline

• Start date: 2016-08-21
• Primary completion: 2018-07-13
• Completion: 2018-07-13
• First posted: 2016-06-20
• Last updated: 2019-07-15

Locations

4 sites across 2 countries: Kuwait, United Arab Emirates