Diabetes Mellitus Type 1 Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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