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

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ClinicalTrials.gov Identifier: NCT00923715
Recruitment Status : Unknown
Verified December 2010 by Baylor College of Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : June 18, 2009
Last Update Posted : December 9, 2010
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Insulin Drug: Insulin and Exenatide Drug: Insulin and Pramlintide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exenatide (Byetta) Vs Pramlintide (Symlin): Role in Post-Prandial Hyperglycemia
Study Start Date : August 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Insulin only Drug: Insulin
Dose will be as per usual home regimen.
Experimental: Insulin and Exenatide Drug: Insulin and Exenatide
Exenatide 1.25 up to 2.5 mcg will be given before breakfast and before supper
Experimental: Insulin and Pramlintide Drug: Insulin and Pramlintide
Pramlintide 15 to 45 mcg will be given before breakfast and supper

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: 16 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923715

United States, New York
Montefiore Medical Center CRC
Bronx, New York, United States, 10461
Sponsors and Collaborators
Baylor College of Medicine
Albert Einstein College of Medicine, Inc.
Principal Investigator: Rubina A Heptulla, MD Albert Einstein College of Medicine, Inc.
More Information

Responsible Party: Rubina A. Heptulla, MD, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00923715     History of Changes
Other Study ID Numbers: H-24391
R01DK077166-01 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

Keywords provided by Baylor College of Medicine:
Diabetes Mellitus, Type 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action