- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01916265
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
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
NRW
-
Neuss, NRW, Germany, 41460
- Profil Institut für Stoffwechselforschung GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glucagon level: 0,11 and 1 mg
|
|
Experimental: Glucagon level: 0,22 and 0,66 mg
|
|
Experimental: Glucagon level: 0,44 and 0,33 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCGlucose of different glucagon dosages given s.c.
Time Frame: 90 min after dosing
|
90 min after dosing
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCDiab01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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