Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
Information source: Profil Institut für 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 für 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
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