Diabetes Mellitus, Type 2CONVERGENCT05542420
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.
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 3,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 19 Oct 2022to 20 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients with T2DM fulfilling the inclusion criteria
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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.
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
The study will be based on data already recorded in the medical record
| Study group | Role | What they receive |
|---|---|---|
| Real world adult population with type 2 diabetes mellitus (T2DM) | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (body mass index)
BMI will be calculated from height and weight data reported as percent of patients
Measured: 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
Reported as mmHg
Measured: 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)
Will be reported as percent of patients
Measured: 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
Will be reported as percent of patients
Measured: Since the start of medical record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start19 Oct 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542420
- Sponsor's protocol ID
- DAS-7528
- Other IDs
- U1111-1273-4446
- Acronym
- CONVERGE
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05542420
- Acronym / sponsor ID
- CONVERGE / DAS-7528
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real world adult population with type 2 diabetes mellitus (T2DM) | – | Other: No treatment given |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with T2DM fulfilling the inclusion criteria
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenThe study will be based on data already recorded in the medical record | Other | Real world adult population with type 2 diabetes mellitus (T2DM) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, Pakistan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.