Status:
COMPLETED
Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
Lead Sponsor:
Profil Institut für Stoffwechselforschung GmbH
Collaborating Sponsors:
European Union
Conditions:
Diabetes Mellitus Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
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...
Eligibility Criteria
Inclusion
- Male or female subjects with diabetes mellitus type 1 , as defined by the American Diabetes Association1.
- Age ≥ 18 and ≤ 65 years.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01916265
Start Date
August 1 2013
End Date
November 1 2013
Last Update
February 5 2014
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, Germany, 41460