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

This study has been completed.
Amylin Pharmaceuticals, LLC.
Information provided by:
Baylor College of Medicine Identifier:
First received: March 1, 2007
Last updated: November 30, 2010
Last verified: November 2010

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 Intervention Phase
Type 1 Diabetes Mellitus
Drug: Pramlintide acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Postprandial Hyperglycemia With Adjuvant Premeal Pramlintide and Postmeal Insulin in Children With Type 1 Diabetes Mellitus.

Resource links provided by NLM:

Further study details as provided by Baylor College of Medicine:

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

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

Enrollment: 8
Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pramlintide acetate
    Pramlintide given before meal and insulin given after meal

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00442767

United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Amylin Pharmaceuticals, LLC.
Principal Investigator: Rubina A Heptulla, MD Baylor College of Medicine
  More Information

Responsible Party: Rubina A Heptulla, MD, Baylor College of Medicine Identifier: NCT00442767     History of Changes
Other Study ID Numbers: H-18629  GCRC protocol #:0954 
Study First Received: March 1, 2007
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 30, 2016