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Trial · Interventional

CompletedPhase 3Registry data

Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

NCTNCT00107107 (opens ClinicalTrials.gov in a new tab)Other id137-150E
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
190 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Nov 2002
Primary completion
Jun 2005
Completion
Jun 2005
First posted
6 Apr 2005 (estimated)
Last update posted
23 Sept 2015 (estimated)
Conditions
Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022003200420052006
  1. Ph 3

    Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

    NCT00107107

    Nov 2002 to Jun 2005

Registry summary

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

This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.

Interventions

  • pramlintide acetateDrug

Arms1

  • Active comparator

    Pramlintide Acetate

    Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The concentration of pramlintide injection to be used in this study is 0.6 mg/mL.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150.

    Time frame · participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available

  2. To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight

    Time frame · participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available

Secondary outcomes(1)

  1. To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.

    Time frame · participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available

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.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2008

5 results

Pramlintide reduces the risks associated with glucose variability in type 1 diabetes.

Kovatchev et al. 2008Diabetes technology & therapeuticscited by 9

PMID 18715216PMC2979337DOI 10.1089/dia.2007.0295PUB-18715216

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * The subject has completed the full dosing period in Protocol 137-150.

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