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Trial · Interventional

CompletedPhase 3Registry data

Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

NCTNCT00042458 (opens ClinicalTrials.gov in a new tab)Other id137-150
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Overview

Status
Completed
Phase
Phase 3
Enrollment
296 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Apr 2002
Primary completion
Mar 2003
Completion
Mar 2003
First posted
1 Aug 2002 (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
200220032004
  1. Ph 3

    Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

    NCT00042458

    Apr 2002 to Mar 2003

Registry summary

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

This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.

Interventions

  • Pramlintide acetateDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

    Placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL

  • Active comparator

    Pramlintide Acetate (AC137)

    Pramlintide acetate (AC137) 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 strength of pramlintide injection is 0.6 mg/mL

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. - To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.

    Time frame · 29 Weeks

Secondary outcomes(2)

  1. - To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.

    Time frame · 29 Weeks

  2. - To examine the pattern of daily insulin use over the course of the study.

    Time frame · 29 Weeks

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

Indexing hint: Randomized controlled trial · 2013

11 results

Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy.

Herrmann et al. 2013Postgraduate medicinecited by 20

PMID 23748514DOI 10.3810/pgm.2013.05.2635PUB-23748514

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * HbA1c value between 7.5-9% * Using multiple daily insulin injections

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