Recruiting NCT07606066

A Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies

— Observational Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Procedure: assessment.
Who it may be relevant to: Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Brazil, Hungary, India, Malaysia +2
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is to identify and characterize patients with known Type 2 Diabetes Mellitus (T2DM) for possible participation in ongoing or future T2DM clinical studies, and to characterize trends in key concomitant medication use in this patient population across different geographical regions.

Interventions

Other Procedure: assessment
The approximate volume of blood required is 2 mL

Primary outcome measures

Patient demographics [Time frame: Visit 1 (Single day)]
Medical and surgical history [Time frame: Visit 1 (Single day)]
Concomitant medication [Time frame: Visit 1 (Single day)]
HbA1c levels [Time frame: Visit 1 (Single day)]

Secondary outcome measures (1)

Referral to ongoing or future T2DM study. [Time frame: Visit 1 (Single day)]

Eligibility criteria

Inclusion criteria

Participants must be ≥ 18 years of age at the time of signing the ICF.
Patients with a diagnosis of T2DM, test- or documentation-confirmed as per World

Health Organization or local diagnostic standards, inadequately managed with:

Lifestyle management alone, AND/OR
A stable dose of background glucose-lowering medication(s) for T2DM (As specified in the Protocol) for at least 45 days prior to signing the ICF.

Expresses interest in participating in an ongoing or future T2DM clinical study, is motivated and willing to make themselves available for the duration of the study, and is able to follow study procedures as required.
Provision of signed and dated written informed consent (As specified in the Protocol) before any study-specific procedures, sampling, or analysis.

Exclusion criteria

Current or planned use of GLP-1 RAs prohibited in ongoing or future T2DM studies evaluating the efficacy and safety of investigational GLP-1 RAs (As specified in the Protocol).
Diagnosed with Type 1 diabetes mellitus.
Known pregnancy at the time of visit or having the intention to become pregnant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

India · 19 centers

Research Site — Guntur
Research Site — Guwahati
Research Site — Bangalore
Research Site — Belagavi
Research Site — Belagavi
Research Site — Calicut
Research Site — Kochi
Research Site — Thiruvananthapuram
… and 11 more centers

Brazil · 11 centers

Research Site — Fortaleza
Research Site — Curitiba
Research Site — Natal
Research Site — Porto Alegre
Research Site — Campinas
Research Site — São José dos Campos
Research Site — São Paulo
Research Site — São Paulo
… and 3 more centers

Hungary · 10 centers

Research Site — Budapest
Research Site — Budapest
Research Site — Debrecen
Research Site — Szeged
Research Site — Budapest
Research Site — Budapest
Research Site — Budapest
Research Site — Salgótarján
… and 2 more centers

United States · 9 centers

Research Site — Little Rock
Research Site — Lincoln
Research Site — Lake City
Research Site — Ocoee
Research Site — Decatur
Research Site — El Dorado
Research Site — Potomac
Research Site — Gaffney
… and 1 more center

Poland · 9 centers

Research Site — L Dz
Research Site — Lublin
Research Site — Krakow
Research Site — Radom
Research Site — Bialystok
Research Site — Częstochowa
Research Site — Poznnn
Research Site — Warsaw
… and 1 more center

Turkey (Türkiye) · 8 centers

Research Site — Ankara
Research Site — Adana
Research Site — Adana
Research Site — Ankara
Research Site — Gaziantep
Research Site — Istanbul
Research Site — Istanbul
Research Site — Kayseri

Malaysia · 5 centers

Research Site — Seremban
Research Site — Seri Manjung
Research Site — Batu Caves
Research Site — Kuala Lumpur
Research Site — Putrajaya

Identifiers

NCT: NCT07606066 · D7261C00007

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗