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CompletedPhase 2

Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes

Effect of AC 2993 (Synthetic Exendin-4) - Administered Alone or in Combination With Daclizumab - on Islet Function in Patients With Type I Diabetes

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

47

actual

Study population

Type 1 diabetes

Key I/E criterion

BMI ≥20

Primary endpoint

Basal C-peptide level

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 IDNCT00064714
Org study ID030245 (2993T1-101)
Secondary ID03-DK-0245

Timeline

Milestones

Study first posted2003-07-11estimated
Last update posted2015-03-11estimated
Study start2003-07 (month precision)
Primary completion2008-03actual (month precision)
Study completion2008-03actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

INCLUSION CRITERIA:

T1DM for at least 5 years as defined by the following:

1. Insulin dependence (with an insulin requirement less than 0.8 units/kg/day).

2. Current or past anti-islet antibodies (anti-insulin before initiation of insulin therapy, anti-islet cell (ICA), anti-tyrosine phosphatase IA-2, and/or anti-glutamic acid decarboxylase (GAD65) antibodies).

3. BMI greater than or equal to 20 kg/m(2) and less than or equal to 30 kg/m(2).

C-peptide greater than or equal to 0.3 and less than or equal to 1.2 ng/mL at baseline or during an arginine-stimulated C-peptide test.

Age 18 to 60 years, inclusive.

Exclusion criteria

Symptomatic gastroparesis.

Diabetic nephropathy with a creatinine clearance less than 60 cc/min or 24-hour urine albumin greater than 300 mg.

Insulin requirements greater than 0.8 units/kg/day.

Hypoglycemia unawareness: Unless easily corrected via simple modifications in the patient's diabetes regimen, the potential enrollee will be excluded if he/she has suffered greater than or equal to 2 episodes of severe hypoglycemia during the most recent 12 months, defined as requiring assistance from a third party, receiving assistance from medics, visiting an ER or being hospitalized due to the hypoglycemia.

Evidence of chronic infection.

History of any malignancy.

Any chronic medical condition that unduly increase risk for the potential enrollee as judged by study investigators.

Hematologic abnormalities:

1. Anemia (hematocrit less than 31.8% in women and less than 36.7% in men).

2. Leukopenia (WBC count less than 3.4 K/mm(3)).

3. Thrombocytopenia (platelet count less than 162 K/mm(3)).

Hypertension, whether untreated or resistant to medical treatment, with blood pressure greater than 140/85 mm Hg.

Pregnancy, breastfeeding or planned pregnancy within two years.

Unable to identify primary care provider willing to partner with study investigators.

Endpoints (1)

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.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change in basal C-peptide level

Time frame:baseline and 6 months

percent change from baseline, improvement

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.