We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

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.
ClinicalTrials.gov Identifier: NCT01269047
Recruitment Status : Completed
First Posted : January 4, 2011
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Pramlintide Drug: Exenatide Drug: Insulin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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
Study Start Date : December 2010
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Post-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus. [ Time Frame: through study completion, an average of 1 year ]
    We measured post-prandial blood sugars in both pramlintide and exenatide treated groups in acute and chronic setting, when compared to insulin monotherapy in subjects with Type 1 Diabetes Mellitus


Secondary Outcome Measures :
  1. Looked at HbA1c, Hypoglycemia, and Changes in the Body Fat, Lean Mass, or the Z-score in the Chronic Use Setting. [ Time Frame: Dec 2017 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

Responsible Party: Rubina Heptulla, Division Chief of Pediatric Endocrinology & Diabetes, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT01269047     History of Changes
Other Study ID Numbers: 2010 -436
R01DK077166 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2011    Key Record Dates
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018
Last Verified: February 2018

Keywords provided by Rubina Heptulla, Albert Einstein College of Medicine, Inc.:
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