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Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

P

Profil Institut für Stoffwechselforschung

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus Type 1

Treatments

Drug: Glucagon

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01916265
PCDiab01

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

6 participants in 3 patient groups

Glucagon level: 0,11 and 1 mg
Experimental group
Description:
Glucagon level: 0,11 and 1 mg
Treatment:
Drug: Glucagon
Glucagon level: 0,22 and 0,66 mg
Experimental group
Description:
Glucagon level: 0,22 and 0,66 mg
Treatment:
Drug: Glucagon
Glucagon level: 0,44 and 0,33 mg
Experimental group
Description:
Glucagon level: 0,44 and 0,33 mg
Treatment:
Drug: Glucagon

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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