Clinical trial NCT02805361: Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan-for Dapagliflozin in Management of Type II Diabetes Mellitus
Official title: Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan- for Dapagliflozin in Management of Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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))

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

Eligibility criteria: 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.

Primary outcomes:
measure: The mean change in HbAlc from mean baseline and at Month 12.
timeFrame: 12 Months
Secondary outcomes:
measure: Changes from baseline in Total body weight
timeFrame: 12 Months
measure: Changes from baseline in Total cholesterol
timeFrame: 12 Months
measure: Changes from baseline in Systolic Blood Pressures
timeFrame: 12 Months
measure: Changes from baseline in LDL-C
timeFrame: 12 Months
measure: Changes from baseline in non-HDL-C
timeFrame: 12 Months
measure: Changes from baseline in triglycerides.
timeFrame: 12 Months
measure: Changes from baseline in Diastolic Blood Pressures
timeFrame: 12 Months
Other outcomes:
measure: The frequency & incidence of Hypoglycemic episodes
timeFrame: 12 Months
measure: The frequency & incidence of Volume Depletion.
timeFrame: 12 Months
measure: The frequency & incidence of Genital infections
timeFrame: 12 Months
measure: 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
timeFrame: 12 Months
Locations:
city: Kuwait City
country: Kuwait
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Ajman
country: United Arab Emirates
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
Study officials:
affiliation: Endocrinology Division Departemnt of Medicine, SKMC-UAE
name: Tarek M. Fiad, MBBCH MD FRCPI FRCP
role: PRINCIPAL_INVESTIGATOR
References: