Clinical trial NCT05542420: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-09-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with T2DM fulfilling the inclusion criteria

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: BMI (body mass index)
timeFrame: 6 months prior to Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class) (retrospective)
measure: Most recent blood pressure measurement values
timeFrame: 6 months prior to Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class) (retrospective)
measure: The proportion of patients prescribed glucagon-like peptide-1 receptor agonists (GLP-1 RA)
timeFrame: At Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class)
measure: The proportion of patients prescribed cardiovascular disease (CVD) medications
timeFrame: Since the start of medical record
Secondary outcomes:
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Novo Nordisk Investigational Site
city: Karachi
country: Pakistan
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: