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Trial · Interventional

CompletedPhase 2Registry data

Evaluation of the Bioavailability of Pramlintide

NCTNCT00042471 (opens ClinicalTrials.gov in a new tab)Other id137-153
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Overview

Status
Completed
Phase
Phase 2
Enrollment
75 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2002
Primary completion
Dec 2002
Completion
Dec 2002
First posted
1 Aug 2002 (estimated)
Last update posted
23 Sept 2015 (estimated)
Conditions
Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022003
  1. Ph 2

    Evaluation of the Bioavailability of Pramlintide

    NCT00042471

    Jun 2002 to Dec 2002

Registry summary

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

This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.

Interventions

  • Pramlintide acetateDrug

Arms1

  • Experimental

    Pramlintide acetate (AC137) injection

    Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Effect of varying needle length on bioavailability of Pramlintide

    Time frame · approximately 6days but not to exceed 14days

    Registry description

    To determine the effect of various anatomical injection sites and varying needle lengths upon the absolute bioavailability of pramlintide when injected subcutaneously (SC) in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin.

Secondary outcomes(1)

  1. Effect of varying needle length on safety and tolerability of Pramlintide

    Time frame · Approximately 6 days not to exceed 14days

    Registry description

    To assess the safety and tolerability of pramlintide when injected SC at various anatomical sites and with various needle lengths in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * HbA1c value between 6-12% * BMI \<= 27 kg/m2 or BMI \>=30 to \<= 45 kg/m2 * Consistent insulin regimen for 2 months prior to screening

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