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

NCT02805361 | Completed

• 1 other identifier: D1690R00028
• Study Type: observational
• Target: 511
• Locations: 2 countries
• Sites: 4

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

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes from baseline in Total body weight

  12 Months

• Changes from baseline in Total cholesterol

  12 Months

• Changes from baseline in Systolic Blood Pressures

  12 Months

• Changes from baseline in LDL-C

  12 Months

• Changes from baseline in non-HDL-C

  12 Months

Other Outcomes (4)

• The frequency & incidence of Hypoglycemic episodes

  12 Months

• The frequency & incidence of Volume Depletion.

  12 Months

• The frequency & incidence of Genital infections

  12 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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))

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Kuwait City, Kuwait

Location

Research Site

Abu Dhabi, United Arab Emirates

Location

Research Site

Ajman, United Arab Emirates

Location

Research Site

Dubai, United Arab Emirates

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tarek M. Fiad, MBBCH MD FRCPI FRCP

  Endocrinology Division Departemnt of Medicine, SKMC-UAE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 20, 2016
• Study Start: August 21, 2016
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

AE (3); KU (1)