Clinical trial NCT03071016: Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: T2D,
Type 2 Diabetes,
T2DM
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-03-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes

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).

Eligibility 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

Primary outcomes:
measure: To record the mean change in HbA1C from baseline
timeFrame: 6 months
Secondary outcomes:
measure: To record the change in weight
timeFrame: 6 months
measure: To record the change in blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Nellor
country: India
facility: Research Site
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Research Site
state: Andhra Pradesh
city: Raipur
country: India
facility: Research Site
state: Chhattisgarh
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Ahmedabad
country: India
facility: Research Site
state: Gujrat
city: Rajkot
country: India
facility: Research Site
state: Gujrat
city: Surat
country: India
facility: Research Site
state: Gujrat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Aurangabad
country: India
facility: Research Site
state: Maharashtra
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Amritsar
country: India
facility: Research Site
state: Punjab
city: Bhathinda
country: India
facility: Research Site
state: Punjab
city: Chandigarh
country: India
facility: Research Site
state: Punjab
city: Ludhiana
country: India
facility: Research Site
state: Punjab
city: Patiala
country: India
facility: Research Site
state: Punjab
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Pudhucherry
country: India
facility: Research Site
state: Tamil Nadu
city: Salem
country: India
facility: Research Site
state: Tamil Nadu
city: Hyderabad
country: India
facility: Research Site
state: Telangana
city: Kanpur
country: India
facility: Research Site
state: UP
city: Lucknow
country: India
facility: Research Site
state: UP
city: Jalpaiguri
country: India
facility: Research Site
state: West Bengal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
Study officials:
affiliation: MV Hospital Chennai India
name: Dr Vijay Viswanathan, M.D., Ph.D., FRCP
role: PRINCIPAL_INVESTIGATOR
References: