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

Last updated: December 7, 2010
Sponsor: Baylor College of Medicine
Overall Status: Active - Enrolling

Phase

3

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT00923715
H-24391
RO1DK077166-01
  • Ages 12-21
  • Both

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 63
Study Start date:
August 01, 2009
Estimated Completion Date:
May 31, 2012

Connect with a study center

  • Montefiore Medical Center CRC

    Bronx, New York 10461
    United States

    Site Not Available

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