Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Glucagon level: 0,11 and 1 mg

Group Type EXPERIMENTAL

Glucagon

Intervention Type DRUG

Glucagon level: 0,22 and 0,66 mg

Group Type EXPERIMENTAL

Glucagon

Intervention Type DRUG

Glucagon level: 0,44 and 0,33 mg

Group Type EXPERIMENTAL

Glucagon

Intervention Type DRUG

Interventions

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Glucagon

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No