Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01916265

Enrollment

Registered

2013-08-05

Start date

2013-08-31

Completion date

2013-11-30

Last updated

2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 1

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.

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.

Interventions

DRUGGlucagon

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
AUCGlucose of different glucagon dosages given s.c.	90 min after dosing

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026