Type II Diabetes MellitusREWARDNCT02805361
Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan-for Dapagliflozin in Management of Type II Diabetes Mellitus
An observational study of Type II Diabetes Mellitus, run by AstraZeneca at 4 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes Mellitus
- How many people
- 511 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 21 Aug 2016to 13 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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))
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Arab Emirates3 sites
Research Site
Abu Dhabi
Research Site
Ajman
Research Site
Dubai
About this study
Official title: 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
Read the 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:
- Primary Objective: To describe the change in HbAlc from baseline as a parameter for blood glucose control.
- 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.
- Other Objective: To capture the frequency \& incidence of the following reported adverse events :
- Hypoglycemic episodes.
- Volume Depletion.
- Genital infections.
- Urinary tract infections.
- 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
- Conditions
- Type II Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Secondary outcomes (7)
Changes from baseline in Total body weight
The mean changes from mean baselines and at Month12 in Total body weight.
Measured: 12 Months
Changes from baseline in Total cholesterol
The mean changes from mean baselines and at Month12 in Total cholesterol.
Measured: 12 Months
Changes from baseline in Systolic Blood Pressures
The mean changes from mean baselines and at Month12 in Systolic Blood Pressures
Measured: 12 Months
Changes from baseline in LDL-C
The mean changes from mean baselines and at Month12 in LDL-C
Measured: 12 Months
Changes from baseline in non-HDL-C
The mean changes from mean baselines and at Month12 in non-HDL-C
Measured: 12 Months
Changes from baseline in triglycerides.
The mean changes from mean baselines and at Month12 in triglycerides
Measured: 12 Months
Changes from baseline in Diastolic Blood Pressures
The mean changes from mean baselines and at Month12 in Diastolic Blood Pressures.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start21 Aug 2016
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tarek M. Fiad, MBBCH MD FRCPI FRCP, Principal investigator, Endocrinology Division Departemnt of Medicine, SKMC-UAE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805361
- Sponsor's protocol ID
- D1690R00028
- Acronym
- REWARD
- Status last verified
- Jul 2019
- First submitted
- 9 Jun 2016
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan- for Dapagliflozin in Management of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02805361
- Acronym / sponsor ID
- REWARD / D1690R00028
- Conditions
- Type II Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2016 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Primary Objective: To describe the change in HbAlc from baseline as a parameter for blood glucose control.
- 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.
- Other Objective: To capture the frequency \& incidence of the following reported adverse events :
- Hypoglycemic episodes.
- Volume Depletion.
- Genital infections.
- Urinary tract infections.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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))
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The mean change in HbAlc from mean baseline and at Month 12.
Time frame: 12 Months
Primary Variable: To describe the change in HbAlc from baseline as a parameter for blood glucose controL
7 secondary outcomes
Changes from baseline in Total body weight
Time frame: 12 Months
Changes from baseline in Total cholesterol
Time frame: 12 Months
Changes from baseline in Systolic Blood Pressures
Time frame: 12 Months
Changes from baseline in LDL-C
Time frame: 12 Months
Changes from baseline in non-HDL-C
Time frame: 12 Months
Changes from baseline in triglycerides.
Time frame: 12 Months
Changes from baseline in Diastolic Blood Pressures
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek M. Fiad, MBBCH MD FRCPI FRCP principal investigator
Endocrinology Division Departemnt of Medicine, SKMC-UAE
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes Mellitus, run by AstraZeneca at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Arab Emirates, Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in HbAlc from mean baseline and at Month 12. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.