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Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
Exenatide (Byetta) Vs Pramlintide (Symlin): Role in Post-prandial Hyperglycemia
Lead sponsor
Assets
Exenatide / Pramlintide
Listed sites
1
Recruiting sites
—
Enrollment
37
actual
Study population
Type 1 diabetes
Key I/E criterion
•HbA1c ≤9%
Primary endpoint
•Postprandial glucose
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
1. Age of 12 to 21 years.
2. HbA1C less than 9%
3. Subjects must be on intensive insulin management
4. Tanner stage greater than or equal to 3
5. Having Type 1 Diabetes for at least one year
6. Type 1Diabetes defined by ADA criteria and having at least one of the following antibodies a. Anti-GAD (glutamic acid decarboxylase) b. Anti-islet cell 512 (ICA512) c. Anti-insulin
7. Willing to give consent.
Exclusion criteria
1. Type 2 diabetes.
2. Having any other chronic condition except hypothyroidism stable on medications.
3. On chronic medications that may affect glucose excursions.
4. Anemia as defined as Hb less than 9 gm/dl.
5. Abnormal amylase, lipase or creatinine (twice normal).
6. Abnormal Liver function tests(three times above normal)
7. Unsupportive family environment as determined by clinicians and/or social workers.
8. Pregnant or lactating mothers
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.
Glycemic / diabetes
2 endpointsPost-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus.
Time frame:6 months
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Acute Pramlintide + Insulin Group | 9.03 | — |
| Acute Exenatide + Insulin Group | 8.4 | — |
| Chronic Pramlintide + Insulin Group | 8.0 | — |
| Chronic Exenatide + Insulin Group | 10.2 | — |
| Insulin Monotherapy | 10.8 | — |
Difference in HbA1C Between the Treatment and the Control Groups
Time frame:6 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), percentage of HbA1C values | 95% CI |
|---|---|---|
| Acute Pramlintide + Insulin Group | 0.30 | — |
| Acute Exenatide + Insulin Group | 0.60 | — |
| Chronic Pramlintide + Insulin Group | 0.23 | — |
| Chronic Exenatide + Insulin Group | 0.40 | — |
| Insulin Monotherapy | -0.40 | — |
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.