A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- AUCGlucose of different glucagon dosages given s.c.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects with diabetes mellitus type 1 , as defined by the American Diabetes Association
- •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.
Arms & Interventions
Glucagon level: 0,11 and 1 mg
Glucagon level: 0,11 and 1 mg
Intervention: Glucagon (Drug)
Glucagon level: 0,22 and 0,66 mg
Glucagon level: 0,22 and 0,66 mg
Intervention: Glucagon (Drug)
Glucagon level: 0,44 and 0,33 mg
Glucagon level: 0,44 and 0,33 mg
Intervention: Glucagon (Drug)
Outcomes
Primary Outcomes
AUCGlucose of different glucagon dosages given s.c.
Time Frame: 90 min after dosing
Secondary Outcomes
No secondary outcomes reported