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

Completed · Phase 4

Conditions studied: Type 1 Diabetes Mellitus

In brief

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 excursions. The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.

Key facts

Study ID

NCT00442767

Run by

Montefiore Medical Center

People needed

8

Starts

2007-02-01

Expected to finish

2009-02-01

Last updated by the study team

2018-07-10

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.