NCT01916265

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 5, 2014

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

July 25, 2013

Last Update Submit

February 4, 2014

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

  • AUCGlucose of different glucagon dosages given s.c.

    90 min after dosing

Study Arms (3)

Glucagon level: 0,11 and 1 mg

EXPERIMENTAL

Glucagon level: 0,11 and 1 mg

Drug: Glucagon

Glucagon level: 0,22 and 0,66 mg

EXPERIMENTAL

Glucagon level: 0,22 and 0,66 mg

Drug: Glucagon

Glucagon level: 0,44 and 0,33 mg

EXPERIMENTAL

Glucagon level: 0,44 and 0,33 mg

Drug: Glucagon

Interventions

GlucagonDRUG
Glucagon level: 0,11 and 1 mgGlucagon level: 0,22 and 0,66 mgGlucagon level: 0,44 and 0,33 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProglucagonPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

August 5, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

February 5, 2014

Record last verified: 2013-08

Locations

DE(1)