Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to determine the effects of 16 weeks of adjunctive pramlintide or exenatide use on glycemic control in Type 1 Diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Baylor College of Medicine
• Collaborators: Albert Einstein College of Medicine of Yeshiva University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Exenatide; Insulin; Insulin, Globin Zinc; Islet Amyloid Polypeptide; Pramlintide

Criteria

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