Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00442767
First received: March 1, 2007
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

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:

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

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
  Eligibility
Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
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:
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

ClinicalTrials.gov processed this record on September 23, 2016