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.

Diabetes Mellitus, Type 2 Clinical Trial

— CONVERGE  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05542420
• Other study ID #: DAS-7528
• Secondary ID: U1111-1273-4446
• Status: Completed
• Start date: October 19, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• No treatment given
The study will be based on data already recorded in the medical record

Locations

Country	Name	City	State
India	Novo Nordisk Investigational Site	Bengaluru
Pakistan	Novo Nordisk Investigational Site	Karachi
Thailand	Novo Nordisk Investigational Site	Bangkok
Thailand	Ramathibodi Hospital_Bangkok	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

India,  Pakistan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	The proportion of patients prescribed cardiovascular disease (CVD) medications	Will be reported as percent of patients	Since the start of medical record