Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

February 4, 2014 updated by: Profil Institut für Stoffwechselforschung GmbH

A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations

The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with T1DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is planned as open, randomised 3-period cross-over in patients with T1DM. The study will include a total of 6 completing patients. The study is not blinded due to the exploratory nature.

At each of the 3 periods, different blood glucose level will be established in 4 steps (8, 6, 4, and 2.8 mmol/L), and a prefixed glucagon dose will be given per glucose level. The sequence of glucagon dose strength for the three dosing days will be randomized.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Neuss, NRW, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects with diabetes mellitus type 1 , as defined by the American Diabetes Association1.
  • Age ≥ 18 and ≤ 65 years.

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Receipt of any investigational medicinal product within 3 months or 5 half-lives of that IMP before randomisation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucagon level: 0,11 and 1 mg
Drug: Glucagon
Experimental: Glucagon level: 0,22 and 0,66 mg
Drug: Glucagon
Experimental: Glucagon level: 0,44 and 0,33 mg
Drug: Glucagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCGlucose of different glucagon dosages given s.c.
Time Frame: 90 min after dosing
90 min after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Collaborators

European Union

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCDiab01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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