Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes

Withdrawn before enrolling · Phase 4

Conditions studied: Type 1 Diabetes

In brief

In this pilot study we are evaluating the efficacy of pramlintide on preventing weight gain among early onset type 1 diabetes. We are also evaluating the safety and the effects of treatment with pramlintide on early diagnosed type 1 diabetic subjects, especially among pediatric subjects.

Key facts

Study ID

NCT00505882

Run by

University of Texas Southwestern Medical Center

People needed

0

Starts

2007-07-01

Expected to finish

2008-12-01

Last updated by the study team

2019-01-08

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 12 to 40 years old
• Type 1 diabetes
• Fasting C-peptide ≤ 1.0 ng/ml
• Early diagnosed type 1 diabetes. (<6 months since diagnosis of type 1 diabetes.)
• HbA1c greater than 7.0 %
• Male, or If female, is nonlactating and has a negative pregnancy test (human chorionic gonadotropin, beta subunit [βhCG]) at Visit 1 (screening).

You may not qualify if…

• Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
• Hepatic disease
• Gastrointestinal disease
• Haematologic disorder
• Cardiovascular disorder
• Organ transplantation
• Hemochromatosis
• HIV, HBV, or HCV infection
• Abuses drugs or alcohol or has a history of abuse
• Eating disorder
• Has donated blood within 60 days
• Has had major surgery or a blood transfusion within 2 months
• Usage of medications that affect weight changes
• Use of medications that affect gastrointestinal motility
• Usage of medications that affect glucose/insulin metabolism
• Received any study medication or has participated in any type of clinical trial within 30 days prior to screening.
• Has known allergies or hypersensitivity to any component of study treatment.

Where it is running

• UT Southwestern at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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