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. (CONVERGE)

June 20, 2024 updated by: Novo Nordisk A/S

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bengaluru, India
        • Novo Nordisk Investigational Site
  • Pakistan
      • Karachi, Pakistan
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand
        • Novo Nordisk Investigational Site
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital_Bangkok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Real world adult population with type 2 diabetes mellitus (T2DM)
Other: No treatment given
The study will be based on data already recorded in the medical record

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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)
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
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
Time Frame: Since the start of medical record
Will be reported as percent of patients
Since the start of medical record

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAS-7528
  • U1111-1273-4446 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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