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Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00442767
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : December 2, 2010
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by:
Baylor College of Medicine

Study Description
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Brief Summary:

The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal has been taken vs. standard therapy of pre-meal insulin on post-prandial glucose excursions.

The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Pramlintide acetate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Postprandial Hyperglycemia With Adjuvant Premeal Pramlintide and Postmeal Insulin in Children With Type 1 Diabetes Mellitus.
Study Start Date : February 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: Pramlintide acetate
    Pramlintide given before meal and insulin given after meal

Outcome Measures
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Primary Outcome Measures :
  1. Blood glucose level [ Time Frame: at the time of the study ]

Secondary Outcome Measures :
  1. Insulin levels [ Time Frame: at the time of the study ]
  2. Glucagon levels [ Time Frame: at the time of the study ]

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
Criteria

Inclusion Criteria:

  • type 1 diabetes only
  • diagnosed with T1DM for at least 1 year
  • HbA1C less than or equal to 8.5%
  • currently treated using insulin glargine with or without Humalog/ Novolog OR on the insulin pump
  • hemoglobin equal to or greater than 12mg/dL
  • otherwise healthy, EXCEPT for T1DM and treated hypothyroidism
  • negative pregnancy test, in the case of females

Exclusion Criteria:

  • lack of supportive family
  • evidence or history of chemical abuse
  • BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age
  • patient who is poorly compliant with current insulin management and/or prescribed self blood glucose monitoring
  • patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/ hospitalizations) in the past 6 months
  • have hypoglycemia unawareness
  • have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility
  • pregnant or lactating patients, or patients planning on becoming pregnant
Contacts and Locations
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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): NCT00442767


Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Rubina A Heptulla, MD Baylor College of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Rubina A Heptulla, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00442767     History of Changes
Other Study ID Numbers: H-18629
GCRC protocol #:0954
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: November 2010

Keywords provided by Baylor College of Medicine:
pediatric
juvenile
diabetes mellitus
Pediatric type 1 diabetes mellitus

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