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

NCT ID: NCT03071016

Last Updated: 2019-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-04

Study Completion Date

2018-03-03

Brief Summary

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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

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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

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Vijay Viswanathan, M.D., Ph.D., FRCP

Role: PRINCIPAL_INVESTIGATOR

MV Hospital Chennai India

Locations

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Research Site

Hyderabad, Andhra Pradesh, India

Site Status

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Nellor, Andhra Pradesh, India

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Vijayawada, Andhra Pradesh, India

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Raipur, Chhattisgarh, India

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Ahmedabad, Gujarat, India

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Rajkot, Gujarat, India

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Surat, Gujarat, India

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Bangalore, Karnataka, India

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Aurangabad, Maharashtra, India

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Mumbai, Maharashtra, India

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Nagpur, Maharashtra, India

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Pune, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Amritsar, Punjab, India

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Bhathinda, Punjab, India

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Chandigarh, Punjab, India

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Ludhiana, Punjab, India

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Patiāla, Punjab, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Coimbatore, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Pudhucherry, Tamil Nadu, India

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Salem, Tamil Nadu, India

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Hyderabad, Telangana, India

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Kanpur, Uttar Pradesh, India

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Lucknow, Uttar Pradesh, India

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Jalpāiguri, West Bengal, India

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Kolkata, West Bengal, India

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Countries

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India

Related Links

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Other Identifiers

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D1690R00029

Identifier Type: -

Identifier Source: org_study_id

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