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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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.

Disqualifiers

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.

Trial population

Adults with Type 2 Diabetes

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Procedure: assessment

    Other intervention

    The approximate volume of blood required is 2 mL

Treatment groups

2,150 Participants
are divided into 1 treatment group
Group A: Participants with Type 2 Diabetes1 intervention

Trial outcomes

Primary outcomes

1

Patient demographics

Summary statistics

Time frame
Visit 1 (Single day)
2

Medical and surgical history

Summary statistics

Time frame
Visit 1 (Single day)
3

Concomitant medication

Summary statistics

Time frame
Visit 1 (Single day)
4

HbA1c levels

Summary statistics

Time frame
Visit 1 (Single day)

Secondary outcomes

1

Referral to ongoing or future T2DM study.

Number of participants with high likelihood of meeting eligibility criteria in ongoing or future T2DM studies, for referral to those studies.

Time frame
Visit 1 (Single day)

Other outcomes

Sponsors and contacts

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