Exenatide (Byetta) Versus Pramlintide (Symlin): Role in Post-Prandial Hyperglycemia
Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 1
Intervention: Insulin (Drug); Insulin and Exenatide (Drug); Insulin and Pramlintide (Drug)
Phase: Phase 3
Status: Enrolling by invitation
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s): Rubina A Heptulla, MD, Principal Investigator, Affiliation: Albert Einstein College of Medicine of Yeshiva University
Summary
The purpose of this study is to determine whether exenatide and pramlintide will improve
blood glucose control after meals when compared to insulin alone.
Clinical Details
Official title: Exenatide (Byetta) Vs Pramlintide (Symlin): Role in Post-Prandial Hyperglycemia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To examine the effect of exenatide vs. pramlintide adjunctive therapy in addition to insulin on glycemic control in T1DM as compared to mono-therapy of insulin.
Eligibility
Minimum age: 12 Years.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age of 12 to 21 years.
2. HbA1C less than 9%
3. Subjects must be on intensive insulin management
4. C-peptide less than 0. 3 ng/ml
5. Tanner stage greater than or equal to 3
6. Having T1DM for at least one year
7. T1DM 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
8. 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 AST, ALT, amylase, lipase or creatinine (twice normal).
6. Unsupportive family environment as determined by clinicians and/or social workers.
7. Pregnant or lactating mothers
Locations and Contacts
Montefiore Medical Center CRC, Bronx, New York 10461, United States
Additional Information
Starting date: August 2009
Last updated: December 7, 2010
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