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.

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT05542420
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-15
• Study Start: 2022-10-19
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Real world adult population with type 2 diabetes mellitus (T2DM)	No treatment given	-

Primary Outcome Measures

Name	Time	Method
The proportion of patients prescribed glucagon-like peptide-1 receptor agonists (GLP-1 RA)	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	Since the start of medical record	Will be reported as percent of patients
BMI (body mass index)	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	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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇭 Bangkok, Thailand