An observational study in Type II Diabetes Mellitus, sponsored by AstraZeneca. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-15.
Sponsored by AstraZeneca · Observational
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:
Primary Objective:
To describe the change in HbAlc from baseline as a parameter for blood glucose control.
Secondary Objective:
To describe the changes from baseline in the following parameters:
Other Objective:
To capture the frequency \& incidence of the following reported adverse events :
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
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 511 is above the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Males and females participants aged 18 years and older who are diagnosed type 2 Diabetic patients (Based on American Diabetes Association diagnostic criteria (ADA))
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The target population will be selected according to the following inclusion criteria:
Exclusion Criteria:
The mean change in HbAlc from mean baseline and at Month 12.
Primary Variable: To describe the change in HbAlc from baseline as a parameter for blood glucose controL
Time frame: 12 Months
Changes from baseline in Total body weight
The mean changes from mean baselines and at Month12 in Total body weight.
Time frame: 12 Months
Changes from baseline in Total cholesterol
The mean changes from mean baselines and at Month12 in Total cholesterol.
Time frame: 12 Months
Changes from baseline in Systolic Blood Pressures
The mean changes from mean baselines and at Month12 in Systolic Blood Pressures
Time frame: 12 Months
Changes from baseline in LDL-C
The mean changes from mean baselines and at Month12 in LDL-C
Time frame: 12 Months
Changes from baseline in non-HDL-C
The mean changes from mean baselines and at Month12 in non-HDL-C
Time frame: 12 Months
Changes from baseline in triglycerides.
The mean changes from mean baselines and at Month12 in triglycerides
Time frame: 12 Months
Changes from baseline in Diastolic Blood Pressures
The mean changes from mean baselines and at Month12 in Diastolic Blood Pressures.
Time frame: 12 Months
The frequency & incidence of Hypoglycemic episodes
The frequency \& incidence of the following reported adverse events during the 12 Months period of the study: Hypoglycemic episodes.
Time frame: 12 Months
The frequency & incidence of Volume Depletion.
The frequency \& incidence of the following reported adverse events during the 12 Months period of the study: Volume Depletion.
Time frame: 12 Months
The frequency & incidence of Genital infections
The frequency \& incidence of the following reported adverse events during the 12 Months period of the study: Genital infections
Time frame: 12 Months
Capture influence of the combined effect of fasting and hot climate on the level of total ketone bodies levels in T2DM subjects treated with Dapagliflozin
Quantitative estimation of capillary ketone bodies will be carried out within 3-months prior Ramadan in selected centers where this is a routine clinic practice. In patients where quantitative estimation of capillary ketone bodies was measured prior to Ramadan, another measurement will be carried out during Ramadan if the date of patient routine follow-up visit coincided with the month of Ramadan. In case visit coincides with only a couple of days of fasting, measurements would be taken into the middle and/or the end of Ramadan. In case someone is recruited during Ramadan, baseline recorded measurements must be prior to Ramadan
Time frame: 12 Months
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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