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Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01269047
First received: December 29, 2010
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
 Drug: Pramlintide
Drug: Exenatide
Drug: Insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover 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 Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • To determine the effects of 16 weeks of adjunctive pramlintide or exenatide use on glycemic control in Type 1 diabetes mellitus. [ Time Frame: July 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: December 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pramlintide + Insulin Group
These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
 Drug: Pramlintide
Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
Other Names:
  • Symlin
  • Pramlintide
Experimental: Exenatide + Insulin Group
This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
 Drug: Exenatide
Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
Other Names:
  • Exenatide
  • Byetta
  • Type 1 diabetes
Active Comparator: Insulin monotherapy
This group will be on their regular insulin therapy.
 Drug: Insulin
Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.
Other Names:
  • Novolog
  • Humalog
  • Levemir
  • Lantus

  Show Detailed Description

  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. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269047

Locations
United States, New York
Albert Einstein College of Medicine West Campus Clinical Research Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rubina A Heptulla, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Rubina Heptulla, Division Chief of Pediatric Endocrinology & Diabetes, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01269047     History of Changes
Other Study ID Numbers: 2010 -436, R01DK077166
Study First Received: December 29, 2010
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
type 1 diabetes
Symlin
Byetta
CGMS iPro

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 19, 2013