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.

NCT ID: NCT05542420

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-19

Study Completion Date

2023-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Real world adult population with type 2 diabetes mellitus (T2DM)

No treatment given

Intervention Type OTHER

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

Interventions

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No treatment given

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Bengaluru, , India

Site Status

Novo Nordisk Investigational Site

Karachi, , Pakistan

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Countries

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India Pakistan Thailand

Other Identifiers

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U1111-1273-4446

Identifier Type: OTHER

Identifier Source: secondary_id

DAS-7528

Identifier Type: -

Identifier Source: org_study_id

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