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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Albert Einstein College of Medicine of Yeshiva University
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00923715
First received: June 16, 2009
Last updated: December 7, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
 Drug: Insulin
Drug: Insulin and Exenatide
Drug: Insulin and Pramlintide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exenatide (Byetta) Vs Pramlintide (Symlin): Role in Post-Prandial Hyperglycemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: August 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923715

Locations
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 of Yeshiva University
Investigators
Principal Investigator: Rubina A Heptulla, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Rubina A. Heptulla, MD, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00923715     History of Changes
Other Study ID Numbers: H-24391, RO1DK077166-01
Study First Received: June 16, 2009
Last Updated: December 7, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Exenatide
Pramlintide
 Insulin
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013