A Research Study, Looking at the Characterization of Treatment Intensified (Add on to Metformin) Real-world Adult Population With Type 2 Diabetes Mellitus in India, Pakistan and Thailand.

NCT05542420 | Completed

• 2 other identifiers: DAS-7528U1111-1273-4446
• Study Type: observational
• Target: 3,000
• Locations: 3 countries
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• BMI (body mass index)

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

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

• Most recent blood pressure measurement values

  Reported as mmHg

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

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

  Will be reported as percent of patients

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

• The proportion of patients prescribed cardiovascular disease (CVD) medications

  Will be reported as percent of patients

  Since the start of medical record

Study Arms (1)

Real world adult population with type 2 diabetes mellitus (T2DM)

Other: No treatment given

Interventions

No treatment given OTHER

The study will be based on data already recorded in the medical record

Real world adult population with type 2 diabetes mellitus (T2DM)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with T2DM fulfilling the inclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Novo Nordisk Investigational Site

Bengaluru, India

Location

Novo Nordisk Investigational Site

Karachi, Pakistan

Location

Novo Nordisk Investigational Site

Bangkok, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 15, 2022
• Study Start: October 19, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

IN (1); PA (1); TH (1)