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Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

Information source: Profil Institut fr Stoffwechselforschung GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus Type 1

Intervention: Glucagon (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Profil Institut fr Stoffwechselforschung GmbH

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: AUCGlucose of different glucagon dosages given s.c.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 and Contacts

Profil Institut für Stoffwechselforschung GmbH, Neuss, NRW 41460, Germany
Additional Information

Starting date: August 2013
Last updated: February 4, 2014

Page last updated: August 23, 2015

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