Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
- Registration Number
- NCT01916265
- Lead Sponsor
- Profil Institut für Stoffwechselforschung GmbH
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glucagon level: 0,22 and 0,66 mg Glucagon Glucagon level: 0,22 and 0,66 mg Glucagon level: 0,11 and 1 mg Glucagon Glucagon level: 0,11 and 1 mg Glucagon level: 0,44 and 0,33 mg Glucagon Glucagon level: 0,44 and 0,33 mg
- Primary Outcome Measures
Name Time Method AUCGlucose of different glucagon dosages given s.c. 90 min after dosing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, NRW, Germany