A Phase 1 interventional study of Glucagon in Diabetes Mellitus Type 1, sponsored by Profil Institut für Stoffwechselforschung GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-02-05.
Sponsored by Profil Institut für Stoffwechselforschung GmbH · Phase 1, Interventional, and Basic science
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 6 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Profil Institut für Stoffwechselforschung GmbH is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Glucagon level: 0,11 and 1 mg
Drug: Glucagon
Glucagon level: 0,22 and 0,66 mg
Drug: Glucagon
Glucagon level: 0,44 and 0,33 mg
Drug: Glucagon
AUCGlucose of different glucagon dosages given s.c.
Time frame: 90 min after dosing
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Profil Institut für Stoffwechselforschung GmbH