Usage of Dapagliflozin in the management of Type-2 Diabetes Mellitus in Indian patients

Completed

• Conditions: Type 2 Diabetes

• Registration Number: CTRI/2017/03/008011
• Lead Sponsor: AstraZeneca Pharma India Ltd

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 would enroll 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

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

Inclusion Criteria

• Patients who provide written informed consent.
• Patients with previously diagnosed Type-2 diabetes mellitus 3.
• 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.
• 5.Patients who are having past medical records for demographic information, weight, blood pressure and HbA1c value at the time of dapagliflozin prescribed.

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
Mean change in HbA1C	6 month

Secondary Outcome Measures

Name	Time	Method
Mean change in weight and BP	6 month

Trial Locations

Locations (9)

Bengalore Diabetes Centre; 🇮🇳 Bangalore, KARNATAKA, India

CMRI; 🇮🇳 Kolkata, WEST BENGAL, India

Dr KN Manohar Clinic; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Dr Mahesh Babu Clinic; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Dr Nadeem rais; 🇮🇳 Mumbai, MAHARASHTRA, India

Fortis Medcentre; 🇮🇳 Chandigarh, CHANDIGARH, India

K D Modi clinic; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Orange Diabetes Speciality Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Poona Diabetes Centre; 🇮🇳 Pune, MAHARASHTRA, India

Bengalore Diabetes Centre

🇮🇳Bangalore, KARNATAKA, India

Dr Paramesh Shamanna

Principal investigator

9845010359

dr_paramesh@hotmail.com