- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Barretos, Brazil, 14784-400
- Not yet recruiting
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Brasília, Brazil, 71625-009
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Rio de Janeiro, Brazil, 22270-060
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Ceará
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Fortaleza, Ceará, Brazil, 60430-350
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Paraná
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Curitiba, Paraná, Brazil, 80030-480
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazil, 59020-035
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90630-165
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S O Paulo
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Campinas, S O Paulo, Brazil, 13060-904
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São José dos Campos, S O Paulo, Brazil, 12243-280
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São Paulo
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São Paulo, São Paulo, Brazil, 01228-200
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São Paulo, São Paulo, Brazil, 04012-180
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Budapest, Hungary, 1138
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Budapest, Hungary, 1132
- Recruiting
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Budapest, Hungary, 1024
- Recruiting
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Salgótarján, Hungary, 3100
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Szolnok, Hungary, 5000
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Zalaegerszeg, Hungary, 8900
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HU
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Budapest, HU, Hungary, 1036
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Budapest, HU, Hungary, 1089
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Debrecen, HU, Hungary, 4032
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Szeged, HU, Hungary, 6725
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, 522001
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Assam
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Guwahati, Assam, India, 781032
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Karnataka
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Bangalore, Karnataka, India, 560092
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Belagavi, Karnataka, India, 590006
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Belagavi, Karnataka, India, 590010
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Kerala
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Calicut, Kerala, India, 673008
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Kochi, Kerala, India, 682041
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Thiruvananthapuram, Kerala, India, 695031
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Madhya Pradesh
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Indore, Madhya Pradesh, India, 452008
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Maharashtra
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Mumbai, Maharashtra, India, 400012
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Nagpur, Maharashtra, India, 440010
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Pune, Maharashtra, India, 411013
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Pune, Maharashtra, India, 411021
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New Delhi
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Delhi, New Delhi, India, 110029
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Rajasthan
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Jaipur, Rajasthan, India, 302017
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600086
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Coimbatore, Tamil Nadu, India, 641018
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226030
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West Bengal
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Kolkata, West Bengal, India, 700020
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Putrajaya, Malaysia, 62250
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Negeri Sembilan
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Seremban, Negeri Sembilan, Malaysia, 70300
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Perak
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Seri Manjung, Perak, Malaysia, 32040
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Selangor
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Batu Caves, Selangor, Malaysia, 68100
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Wilayah Persekutuan Kuala Lump
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Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia, 59100
- Not yet recruiting
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Poznnn, Poland, 60-354
- Active, not recruiting
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Warsaw, Poland, 00-124
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L Dzkie
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L Dz, L Dzkie, Poland, 90-338
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Poland, 20-718
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Malopolska
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Krakow, Malopolska, Poland, 31-261
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Masovian Voivodeship
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Radom, Masovian Voivodeship, Poland, 26-600
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Poland, 15-879
- Recruiting
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Silesian Voivodeship
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Częstochowa, Silesian Voivodeship, Poland, 42-217
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Świętokrzyskie Voivodeship
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Kielce, Świętokrzyskie Voivodeship, Poland, 25-355
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Adana, Turkey (Türkiye), 01060
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Adana, Turkey (Türkiye), 01250
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Ankara, Turkey (Türkiye), 06530
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Gaziantep, Turkey (Türkiye), 27470
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Istanbul, Turkey (Türkiye), 34384
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Istanbul, Turkey (Türkiye), 34265
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Kayseri, Turkey (Türkiye), 38039
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Turkey
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Ankara, Turkey, Turkey (Türkiye), 6100
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Not yet recruiting
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California
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Lincoln, California, United States, 95648
- Recruiting
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Florida
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Lake City, Florida, United States, 32055
- Not yet recruiting
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Ocoee, Florida, United States, 34761
- Recruiting
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Georgia
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Decatur, Georgia, United States, 30030
- Recruiting
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Kansas
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El Dorado, Kansas, United States, 67042
- Not yet recruiting
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Maryland
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Potomac, Maryland, United States, 20854
- Recruiting
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South Carolina
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Gaffney, South Carolina, United States, 29340
- Active, not recruiting
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Washington
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Renton, Washington, United States, 98057
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Participants with Type 2 Diabetes
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The approximate volume of blood required is 2 mL
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient demographics
Time Frame: Visit 1 (Single day)
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Summary statistics
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Visit 1 (Single day)
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Medical and surgical history
Time Frame: Visit 1 (Single day)
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Summary statistics
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Visit 1 (Single day)
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Concomitant medication
Time Frame: Visit 1 (Single day)
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Summary statistics
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Visit 1 (Single day)
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HbA1c levels
Time Frame: Visit 1 (Single day)
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Summary statistics
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Visit 1 (Single day)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Referral to ongoing or future T2DM study.
Time Frame: Visit 1 (Single day)
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Number of participants with high likelihood of meeting eligibility criteria in ongoing or future T2DM studies, for referral to those studies.
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Visit 1 (Single day)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D7261C00007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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