Exenatide (Byetta) Versus Pramlintide (Symlin): Role in Post-Prandial Hyperglycemia

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Exenatide (Byetta) Vs Pramlintide (Symlin): Role in Post-Prandial Hyperglycemia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00923715
• Other study ID #: H-24391
• Secondary ID: RO1DK077166-01
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: June 16, 2009
• Last updated: December 7, 2010
• Start date: August 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2010
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 63
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hyperglycemia

Intervention

Drug:
• Insulin
Dose will be as per usual home regimen.
• Insulin and Exenatide
Exenatide 1.25 up to 2.5 mcg will be given before breakfast and before supper
• Insulin and Pramlintide
Pramlintide 15 to 45 mcg will be given before breakfast and supper

Locations

Country	Name	City	State
United States	Montefiore Medical Center CRC	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Albert Einstein College of Medicine of Yeshiva University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		16 weeks	No