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

• Status: Withdrawn
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Insulin; Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.