Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-28 @ 8:20 PM
Study NCT ID:
NCT02805361
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan-for Dapagliflozin in Management of Type II Diabetes Mellitus
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan- for Dapagliflozin in Management of Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REWARD
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: