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

AstraZeneca

Status: Completed

Conditions: Type II Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT02805361

D1690R00028

Details and patient eligibility

About

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

Full 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

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.