Back to resultsTrial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
Primary Purpose
Diabetes Mellitus Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Glucagon
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus Type 1
Eligibility Criteria
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.
Sites / Locations
- Profil Institut für Stoffwechselforschung GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Glucagon level: 0,11 and 1 mg
Glucagon level: 0,22 and 0,66 mg
Glucagon level: 0,44 and 0,33 mg
Arm Description
Glucagon level: 0,11 and 1 mg
Glucagon level: 0,22 and 0,66 mg
Glucagon level: 0,44 and 0,33 mg
Outcomes
Primary Outcome Measures
AUCGlucose of different glucagon dosages given s.c.
Secondary Outcome Measures
Full Information
NCT ID
NCT01916265
First Posted
July 25, 2013
Last Updated
February 4, 2014
Sponsor
Profil Institut für Stoffwechselforschung GmbH
Collaborators
European Union
1. Study Identification
Unique Protocol Identification Number
NCT01916265
Brief Title
Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
Official Title
A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Profil Institut für Stoffwechselforschung GmbH
Collaborators
European Union
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glucagon level: 0,11 and 1 mg
Arm Type
Experimental
Arm Description
Glucagon level: 0,11 and 1 mg
Arm Title
Glucagon level: 0,22 and 0,66 mg
Arm Type
Experimental
Arm Description
Glucagon level: 0,22 and 0,66 mg
Arm Title
Glucagon level: 0,44 and 0,33 mg
Arm Type
Experimental
Arm Description
Glucagon level: 0,44 and 0,33 mg
Intervention Type
Drug
Intervention Name(s)
Glucagon
Primary Outcome Measure Information:
Title
AUCGlucose of different glucagon dosages given s.c.
Time Frame
90 min after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Profil Institut für Stoffwechselforschung GmbH
City
Neuss
State/Province
NRW
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
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