Status:
COMPLETED
Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
12-21 years
Phase:
PHASE4
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 vs. standard therapy of pre-meal insulin on post-prandial glucose excursi...
Detailed Description
Following approval by the Institutional Review Board at Baylor College of Medicine 8 adolescents (6 males, 2 females) with type 1 diabetes were recruited to the open-labeled, non-randomized, crossover...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00442767
Start Date
February 1 2007
End Date
February 1 2009
Last Update
July 10 2018
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467