Type 2 Diabetes
Conditions
Brief summary
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
OTHERProcedure: assessment
The approximate volume of blood required is 2 mL
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Lifestyle management alone, AND/OR 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient demographics | Visit 1 (Single day) | Summary statistics |
| Medical and surgical history | Visit 1 (Single day) | Summary statistics |
| Concomitant medication | Visit 1 (Single day) | Summary statistics |
| HbA1c levels | Visit 1 (Single day) | Summary statistics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Referral to ongoing or future T2DM study. | Visit 1 (Single day) | Number of participants with high likelihood of meeting eligibility criteria in ongoing or future T2DM studies, for referral to those studies. |
Countries
Brazil, Hungary, India, Malaysia, Poland, Turkey (Türkiye), United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed