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

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT03071016
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-01
• Study Start: 2017-03-04
• Study First Posted: 2017-03-06
• Primary Completion: 2018-03-03
• Study Completion: 2018-03-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To record the mean change in HbA1C from baseline	6 months	form basline visit to 6 months visit

Secondary Outcome Measures

Name	Time	Method
To record the change in blood pressure	6 months	from baseline to 6 month visit
To record the change in weight	6 months	from Baseline to 6 month visit

Trial Locations

Locations (1)

Research Site; 🇮🇳 Kolkata, West Bengal, India