Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

Phase 1CompletedNCT01916265

Profil Institut für Stoffwechselforschung GmbH6 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Type 1

Interventions

GlucagonDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

AUCGlucose of different glucagon dosages given s.c.

Time frame: 90 min after dosing

Data from ClinicalTrials.gov

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