Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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|
- AUCGlucose of different glucagon dosages given s.c. [ Time Frame: 90 min after dosing ] [ Designated as safety issue: No ]
|Study Start Date:||August 2013|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Glucagon level: 0,11 and 1 mg
Glucagon level: 0,11 and 1 mg
Experimental: Glucagon level: 0,22 and 0,66 mg
Glucagon level: 0,22 and 0,66 mg
Experimental: Glucagon level: 0,44 and 0,33 mg
Glucagon level: 0,44 and 0,33 mg
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01916265
|Profil Institut für Stoffwechselforschung GmbH|
|Neuss, NRW, Germany, 41460|