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NCT03071016 Clinical Trial

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

Type 2 Diabetes Clinical Trial

— FOREFRONT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03071016
Other study ID # D1690R00029
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 4, 2017
Est. completion date March 3, 2018

Study information
Verified date February 2019
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date March 3, 2018
Est. primary completion date March 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
India Research Site Ahmedabad Gujrat
India Research Site Amritsar Punjab
India Research Site Aurangabad Maharashtra
India Research Site Bangalore Karnataka
India Research Site Bhathinda Punjab
India Research Site Chandigarh Punjab
India Research Site Chennai Tamil Nadu
India Research Site Coimbatore Tamil Nadu
India Research Site Hyderabad Telangana
India Research Site Hyderabad Andhra Pradesh
India Research Site Jaipur Rajasthan
India Research Site Jalpaiguri West Bengal
India Research Site Kanpur UP
India Research Site Kolkata West Bengal
India Research Site Lucknow UP
India Research Site Ludhiana Punjab
India Research Site Madurai Tamil Nadu
India Research Site Mumbai Maharashtra
India Research Site Nagpur Maharashtra
India Research Site Nellor Andhra Pradesh
India Research Site New Delhi Delhi
India Research Site Patiala Punjab
India Research Site Pudhucherry Tamil Nadu
India Research Site Pune Maharashtra
India Research Site Raipur Chhattisgarh
India Research Site Rajkot Gujrat
India Research Site Salem Tamil Nadu
India Research Site Surat Gujrat
India Research Site Vijayawada Andhra Pradesh

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary To record the mean change in HbA1C from baseline form basline visit to 6 months visit 6 months
Secondary To record the change in weight from Baseline to 6 month visit 6 months
Secondary To record the change in blood pressure from baseline to 6 month visit 6 months
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