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Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269047
First Posted: January 4, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exenatide (Byetta) Vs Pramlintide (Symlin): Role in Post-prandial Hyperglycemia

Resource links provided by NLM:


Further study details as provided by Rubina Heptulla, 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 ]

Enrollment: 35
Study Start Date: December 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (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 Name: Symlin
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:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rubina A Heptulla, MD Albert Einstein College of Medicine, Inc.
  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: December 29, 2010
First Posted: January 4, 2011
Last Update Posted: October 12, 2017
Last Verified: January 2016

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

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