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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
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointChange 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
- Diabetes care2009 Dec (month)PMID19808924doi:10.2337/dc09-0773via clinicaltrials gov reference derived + pubmed nct search
- Annual review of immunology2001 (year)PMID11244033doi:10.1146/annurev.immunol.19.1.131via CT.gov background
- Endocrinology and metabolism clinics of North America1991 Sep (month)PMID1935920via CT.gov background
Provenance
Sources
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.