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To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients

NCT04445714 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-11-12

Study results available
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Summary

A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients.

Conditions

Interventions

DRUG

dapagliflozin and saxagliptin

Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally

Sponsors & Collaborators

Principal Investigators

  • Dr Anil Bhansali · Post Graduate Institute of Medical Education and Research, Chandigarh

  • Dr K P Singh · Fortis Hospital Mohali

  • Dr Indira Pattnaik · Sparsh Hospitals & Critical Care (P) Ltd, Bhubaneswar

  • Dr Sandeep Kumar Gupta · M V Hospital &Research centre Lucknow

  • Dr Faraz Farishta · Thumbay Hospital New Life Hyderabad

  • Dr Girithara Jayaram Naidu · KG Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2023-03-14
Completion
2023-03-14

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445714 on ClinicalTrials.gov