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.
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:
- 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)
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)
|
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
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.