DelfaGLP-1 Atlas

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CompletedPhase 3

Extension Study for 2993-112

An Open-Label Extension Study of Protocol 2993-112 to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of AC2993 Given Two Times a Day to Subjects Treated With Metformin Alone

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

226

Recruiting sites

—

Enrollment

225

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•HbA1c, change•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01789957
Org study ID2993-112E

Timeline

Milestones

Study first posted2013-02-12estimated
Last update posted2015-02-24estimated
Study start2002-09 (month precision)
Primary completion2004-06actual (month precision)
Study completion2004-06actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age16 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:

•Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30).
•Male or female. Female individuals must be either 1) postmenopausal as documented by serum FSH measurement unless using estrogen for hormone replacement therapy; or 2) of childbearing potential and used appropriate contraceptive methods (surgical sterility or oral, injected, barrier, intrauterine, or implanted contraceptives) for the duration of Protocol 2993-112. This individual must have a current, negative pregnancy test (human chorionic gonadotropin [HCG], beta subunit) regardless of birth control method used. The individual agrees to continue using birth control throughout the study to prevent pregnancy.
•Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements.

Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:

•Has not completed Protocol 2993-112.
•Female individuals who are pregnant, lactating, or planning to become pregnant.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination)

Time frame:Day 1 of study 2993-112 through extension study termination (up to Week 52)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)

Time frame:Day 1 of study 2993-112 through extension study termination (up to Week 52)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.