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Clinical Trials/NCT05542420
NCT05542420
Completed
Not Applicable

A Multicentre Retrospective Study of Characterization of Treatment Intensified (Add on to Metformin) Real World Adult Population With Type 2 Diabetes Mellitus in India, Pakistan, and Thailand.

Novo Nordisk A/S1 site in 1 country3,000 target enrollmentOctober 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Novo Nordisk A/S
Enrollment
3000
Locations
1
Primary Endpoint
The proportion of patients prescribed glucagon-like peptide-1 receptor agonists (GLP-1 RA)
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aims to describe demographics, clinical, treatment and healthcare resource utilization characteristics with a particular focus on those relating to cardiovascular disease in selected treatment intensified patients with type 2 diabetes in the real-world settings in India, Pakistan, and Thailand.

The study will be based on data already recorded in participants medical record and no new tests or procedures are required as part of the study.

The study will last for about 6 months and it does not affect participants current treatment.

Registry
clinicaltrials.gov
Start Date
October 19, 2022
End Date
April 20, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • Male or female, age above or equal to 18 years at type 2 diabetes mellitus (T2DM) diagnosis
  • Year of birth 1928 or later (age blow 90 years old in 2017)
  • T2DM diagnosis in medical record on or after the date of local GLP-1 RA marketing authorization
  • Medical records documenting prior or ongoing treatment with metformin
  • Medical records documenting treatment with other non-metformin T2DM drugs

Exclusion Criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Patients with any diagnosis of type 1 diabetes mellitus (T1DM)

Outcomes

Primary Outcomes

The proportion of patients prescribed glucagon-like peptide-1 receptor agonists (GLP-1 RA)

Time Frame: At Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class)

Will be reported as percent of patients

The proportion of patients prescribed cardiovascular disease (CVD) medications

Time Frame: Since the start of medical record

Will be reported as percent of patients

BMI (body mass index)

Time Frame: 6 months prior to Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class) (retrospective)

BMI will be calculated from height and weight data reported as percent of patients

Most recent blood pressure measurement values

Time Frame: 6 months prior to Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class) (retrospective)

Reported as mmHg

Study Sites (1)

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