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.

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Bengaluru, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No treatment given

Other

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

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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.

Acronym: CONVERGE

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Sep 15, 2022
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed