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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00442767

First Posted: March 2, 2007

Last Update Posted: December 2, 2010

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:

Amylin Pharmaceuticals, LLC.

Information provided by:

Baylor College of Medicine

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 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.

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: Insulin Pramlintide Pramlintide acetate

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:

Pramlintide given before meal and insulin given after meal

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:

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

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


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 Submitted:	March 1, 2007
First Posted:	March 2, 2007
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

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