Trials / Completed
CompletedNCT01916265
Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Profil Institut für Stoffwechselforschung GmbH · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glucagon |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2013-08-05
- Last updated
- 2014-02-05
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01916265. Inclusion in this directory is not an endorsement.