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PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
Plain-language guide to NCT02081001: phase 2 randomized trial of Glucagon, 19 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02081001
- Phase
- phase 2
- Status
- completed
- Start
- 2014-03
- Completion (planned or actual)
- 2014-08
- Participants
- 19 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Hypoglycemia
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Glucagon.
It had two arms (groups): G-Pump™ (glucagon infusion) (experimental) and one (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 19 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Current usage of subcutaneous insulin pump treatment. Age 18-65 years. C-peptide level \< 0.5 ng/ml. Willingness to follow all study procedures, including attending all clinic visits. Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.
The full record lists 6 inclusion and 25 exclusion criteria; among the exclusions: congestive heart failure, nyha class ii, iii or iv; history of coronary artery disease; active foot ulceration.
How the Study Was Run
Design: randomized, crossover and double-blind.
The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.
In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.
Blinding on both sides kept the participants and researchers unaware of who received Glucagon.
Those kept unaware of assignments: participant and investigator.
It started in 2014-03 with completion listed for 2014-08.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 8 secondary outcomes, for example Glucagon Cmax, Glucose Cmax, Glucagon Tmax, Glucose Tmax, Glucagon AUC and Glucose AUC.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Glucagon in 19 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Glucagon compound page, all human trials.
Our Notes on the Compound
Glucagon: A 29-amino-acid pancreatic hormone that raises blood glucose; used as a rescue medicine for severe low blood sugar and as a diagnostic aid.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.