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Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
This study has been completed.
Sponsor:
Baylor College of Medicine
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
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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
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) |
| 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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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
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 |
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 August 18, 2017