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

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

Study Overview

• Status: Completed
• Conditions: Type II Diabetes Mellitus

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

• Study Type: Observational
• Enrollment (Actual): 511

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait City, Kuwait
    • Research Site
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Research Site
  • Ajman, United Arab Emirates
    • Research Site
  • Dubai, United Arab Emirates
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males and females participants aged 18 years and older who are diagnosed type 2 Diabetic patients (Based on American Diabetes Association diagnostic criteria (ADA))

Description

Inclusion Criteria:

The target population will be selected according to the following inclusion criteria:

• Males and females participants aged 18 years and older who are diagnosed type 2 Diabetic patients- (Based on American Diabetes Association diagnostic criteria (ADA), The ADA defines diabetes as a fasting blood glucose (FBG) of ≥ 126mg/dL or a 2-hour glucose level post oral glucose tolerance test (OGTT) of ≥ 200 mg/dL or HbAJC of ≥ 6.5%).
• Patients treated with Dapagliflozin (as per routine care and in compliance with the locally approved prescribing information) for ≥ 4 weeks and ≤ 16 weeks prior to the recruitment date.
• Patients with CrCl > 60 ml/min or eGFR > 60 ml/min/1.73 m2 should be included in trial.
• Patients providing written informed consent.

Exclusion Criteria:

• Patients with contraindications to Dapagliflozin as per the locally approved prescribing information will be excluded from the study.
• If participating in any clinical trial, the subject cannot take part in this study.
• Patients with clinically significant renal, hepatic, haematological, oncological, endocrine, psychiatric or rheumatic disease.
• Patients who don't have a disease with life expectancy under 1 year.
• Patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2 should be excluded from the trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in Total body weight	The mean changes from mean baselines and at Month12 in Total body weight.	12 Months
Changes from baseline in Total cholesterol	The mean changes from mean baselines and at Month12 in Total cholesterol.	12 Months
Changes from baseline in Systolic Blood Pressures	The mean changes from mean baselines and at Month12 in Systolic Blood Pressures	12 Months
Changes from baseline in LDL-C	The mean changes from mean baselines and at Month12 in LDL-C	12 Months
Changes from baseline in non-HDL-C	The mean changes from mean baselines and at Month12 in non-HDL-C	12 Months
Changes from baseline in triglycerides.	The mean changes from mean baselines and at Month12 in triglycerides	12 Months
Changes from baseline in Diastolic Blood Pressures	The mean changes from mean baselines and at Month12 in Diastolic Blood Pressures.	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	12 Months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Tarek M. Fiad, MBBCH MD FRCPI FRCP, Endocrinology Division Departemnt of Medicine, SKMC-UAE

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2016
• Primary Completion (Actual): July 13, 2018
• Study Completion (Actual): July 13, 2018

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1690R00028