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Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients (FOREFRONT)

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ClinicalTrials.gov Identifier: NCT03071016
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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. 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.

Condition or disease
Type 2 Diabetes

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 Type : Observational [Patient Registry]
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Actual Study Start Date : March 4, 2017
Actual Primary Completion Date : March 3, 2018
Actual Study Completion Date : March 3, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To record the mean change in HbA1C from baseline [ Time Frame: 6 months ]
    form basline visit to 6 months visit


Secondary Outcome Measures :
  1. To record the change in weight [ Time Frame: 6 months ]
    from Baseline to 6 month visit

  2. To record the change in blood pressure [ Time Frame: 6 months ]
    from baseline to 6 month visit


Biospecimen Retention:   None Retained
no samples retained


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type 2 diabetes
Criteria

Inclusion Criteria:

  1. Male or female patients with 18 years and above.
  2. Patients who provide written informed consent.
  3. Patients with previously diagnosed Type-2 diabetes mellitus
  4. Patients with inadequately controlled diabetes (HbA1c >7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment.
  5. Patients who are taking dapagliflozin within last 3 months.

Exclusion Criteria:

  1. Patients with Type-1 diabetes mellitus
  2. Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study
  3. Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071016


Locations
India
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Nellor, Andhra Pradesh, India
Research Site
Vijayawada, Andhra Pradesh, India
Research Site
Raipur, Chhattisgarh, India
Research Site
New Delhi, Delhi, India
Research Site
Ahmedabad, Gujrat, India
Research Site
Rajkot, Gujrat, India
Research Site
Surat, Gujrat, India
Research Site
Bangalore, Karnataka, India
Research Site
Aurangabad, Maharashtra, India
Research Site
Mumbai, Maharashtra, India
Research Site
Nagpur, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Amritsar, Punjab, India
Research Site
Bhathinda, Punjab, India
Research Site
Chandigarh, Punjab, India
Research Site
Ludhiana, Punjab, India
Research Site
Patiala, Punjab, India
Research Site
Jaipur, Rajasthan, India
Research Site
Chennai, Tamil Nadu, India
Research Site
Coimbatore, Tamil Nadu, India
Research Site
Madurai, Tamil Nadu, India
Research Site
Pudhucherry, Tamil Nadu, India
Research Site
Salem, Tamil Nadu, India
Research Site
Hyderabad, Telangana, India
Research Site
Kanpur, UP, India
Research Site
Lucknow, UP, India
Research Site
Jalpaiguri, West Bengal, India
Research Site
Kolkata, West Bengal, India
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dr Vijay Viswanathan, M.D., Ph.D., FRCP MV Hospital Chennai India

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03071016     History of Changes
Other Study ID Numbers: D1690R00029
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:
T2D,
Type 2 Diabetes,
T2DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases