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

NCT00505882 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-01-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pramlintide

Pramlintide will be started at 15 mcg (2.5 units) subcutaneously immediately prior to major meals and it will be increased by 15mcg every 3 days as tolerated (i.e. nausea, vomiting, upset stomach) to a maximum dose of 60 mcg (10 units) before meals. If significant nausea persists at 45 or 60 mcg level, the dose should be decreased to 30 mcg (5 units) before meals. If the 30 mcg dose is not tolerated, investigator will evaluate for possibility of withdrawing the pramlintide. The dose of preprandial short acting insulin (eg: Novolog/Humalog) will be reduced by 30 to 50% at the start of pramlintide 15 mcg (2.5 units) and then will be adjusted every time the dose of pramlintide is increased by 15 mcg (2.5 units) as needed based on blood glucose readings.

DRUG

Glargine

DRUG

Lispro

DRUG

Aspart

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Philip Raskin, M.D. · UT Southwestern at Dallas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00505882 on ClinicalTrials.gov