Type 2 DiabetesFOREFRONTNCT03071016
Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients
An observational study of Type 2 Diabetes, run by AstraZeneca at 29 sites in India.
Trial summary
This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 2,000 participants
- Where
- 29 sitesIndia
- Study dates
- 4 Mar 2017to 3 Mar 2018
- How long will I take part?
- 6 Months
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes
Who may be able to join
- Male or female patients with 18 years and above.
- Patients who provide written informed consent.
- Patients with previously diagnosed Type-2 diabetes mellitus
- Patients with inadequately controlled diabetes (HbA1c >7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment.
- Patients who are taking dapagliflozin within last 3 months.
Who cannot join
- Patients with Type-1 diabetes mellitus
- Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study
- Pregnant or lactating women
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
India29 sites
Research Site
Ahmedabad, Gujarat
Research Site
Amritsar, Punjab
Research Site
Bangalore, Karnataka
Research Site
Bhathinda, Punjab
Research Site
Chandigarh, Punjab
Research Site
Chennai, Tamil Nadu
Research Site
Chhatrapati Sambhajinagar, Maharashtra
Research Site
Coimbatore, Tamil Nadu
Research Site
Hyderabad, Andhra Pradesh
Research Site
Hyderabad, Telangana
Research Site
Jaipur, Rajasthan
Research Site
Jalpāiguri, West Bengal
Research Site
Kanpur, Uttar Pradesh
Research Site
Kolkata, West Bengal
Research Site
Lucknow, Uttar Pradesh
Research Site
Ludhiana, Punjab
Research Site
Madurai, Tamil Nadu
Research Site
Mumbai, Maharashtra
Research Site
Nagpur, Maharashtra
Research Site
Nellor, Andhra Pradesh
Research Site
New Delhi, National Capital Territory of Delhi
Research Site
Patiāla, Punjab
Research Site
Pudhucherry, Tamil Nadu
Research Site
Pune, Maharashtra
Research Site
Raipur, Chhattisgarh
Research Site
Rajkot, Gujarat
Research Site
Salem, Tamil Nadu
Research Site
Surat, Gujarat
Research Site
Vijayawada, Andhra Pradesh
About this study
Official title: Usage of Dapagliflozin - a Sodium Glucose Co-transporter Inhibitor, in the managEment of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients
This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB) and written informed consent of the patient.
Read the detailed description
This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study would enrol T2DM patients who are/were inadequately controlled (HbA1c >7%) with existing anti-diabetic medications and who have been prescribed dapagliflozin 3 months prior to study initiation. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice and prescribed dapagliflozin 3 months before will be screened for enrolment in study. Dosage of dapagliflozin and other medications should be as per the routine clinical practice and prescribing information. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
- Conditions
- Type 2 Diabetes
- Keywords
- T2D,, Type 2 Diabetes,, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
To record the mean change in HbA1C from baseline
form basline visit to 6 months visit
Measured: 6 months
Secondary outcomes (2)
To record the change in weight
from Baseline to 6 month visit
Measured: 6 months
To record the change in blood pressure
from baseline to 6 month visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start4 Mar 2017
- Primary completion3 Mar 2018
- Study completion3 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 2,000 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Vijay Viswanathan, M.D., Ph.D., FRCP, Principal investigator, MV Hospital Chennai India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071016
- Sponsor's protocol ID
- D1690R00029
- Acronym
- FOREFRONT
- Status last verified
- Feb 2019
- First submitted
- 1 Mar 2017
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage of Dapagliflozin - a Sodium Glucose Co-transporter Inhibitor, in the managEment of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients
- ClinicalTrials.gov ID
- NCT03071016
- Acronym / sponsor ID
- FOREFRONT / D1690R00029
- Conditions
- Type 2 Diabetes
- Keywords
- T2D,, Type 2 Diabetes,, T2DM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 3 Mar 2018 (actual)
- First posted
- 6 Mar 2017 (actual)
- 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.
This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB) and written informed consent of the patient.
Detailed description
This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study would enrol T2DM patients who are/were inadequately controlled (HbA1c >7%) with existing anti-diabetic medications and who have been prescribed dapagliflozin 3 months prior to study initiation. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice and prescribed dapagliflozin 3 months before will be screened for enrolment in study. Dosage of dapagliflozin and other medications should be as per the routine clinical practice and prescribing information. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes
Key inclusion criteria (5 listed)
- Male or female patients with 18 years and above.
- Patients who provide written informed consent.
- Patients with previously diagnosed Type-2 diabetes mellitus
- Patients with inadequately controlled diabetes (HbA1c >7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment.
- Patients who are taking dapagliflozin within last 3 months.
Key exclusion criteria (3 listed)
- Patients with Type-1 diabetes mellitus
- Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study
- Pregnant or lactating women
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
To record the mean change in HbA1C from baseline
Time frame: 6 months
form basline visit to 6 months visit
2 secondary outcomes
To record the change in weight
Time frame: 6 months
To record the change in blood pressure
Time frame: 6 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 4 Mar 2019.
- D1690R00029 CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dr Vijay Viswanathan, M.D., Ph.D., FRCP principal investigator
MV Hospital Chennai India
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by AstraZeneca at 29 sites in India.
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 3 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 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in India. 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?
To record the mean change in HbA1C from baseline (time frame: 6 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 4 Mar 2019.