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Trial · Interventional

WithdrawnPhase 4Registry data

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

NCTNCT00505882 (opens ClinicalTrials.gov in a new tab)Other id032007-054
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 4
Enrollment
0 participants (actual)
Sponsor
University of Texas Southwestern Medical Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2007
Primary completion
Dec 2008 (estimated)
Completion
Dec 2008 (estimated)
First posted
25 Jul 2007 (estimated)
Last update posted
8 Jan 2019
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 4

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

    NCT00505882

    Jul 2007 to est. Dec 2008

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PramlintideDrug
  • GlargineDrug
  • LisproDrug
  • AspartDrug

Arms2

  • Active comparator

    Insulin

  • Experimental

    Pramlintide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The change in weight (kg) will be compared between as well as within the placebo and the pramlintide treatment group from baseline to the end of the study.

    Time frame · 6 months

Secondary outcomes(1)

  1. mixed meal tolerance test-the C-peptide area under the curve The HOMA R and McAuley's index HbA1c The event rate of severe hypoglycemia Waist circumference Cardio C-reactive protein level DQOL Safety parameter

    Time frame · 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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