| Trial ID: | L6983 |
| Source ID: | NCT02028078
|
| Associated Drug: |
Insulin Human
|
| Title: |
Pilot Study Investigating the Feasibility of Determining the Endogenous Glucose Production During a Hypoglycaemia
|
| Acronym: |
PILOT_EGP
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin human
|
| Outcome Measures: |
Primary: Tracer to Tracee Ratio (the absolute relative difference ARDi ), 8 hours | Secondary: Tracer to tracee Ratio, For each subject, the mean absolute relative difference (MARD) of the tracer to tracee ratio (4% enrichment) during variable Glucose Infusion Rate from the begin of the experiment until the end of the hypoglycaemic clamp., 8 hours | Other: Time to reach each hypoglycaemic level, The stability of the tracer to tracee ratio during constant insulin infusion rate and for the different plateau levels (5.5, 3.5 and 2.5 mmol/L and for the recovery phase 4.0 mmol/L) will be investigated in an analog way., 8 hours
|
| Sponsor/Collaborators: |
Sponsor: Medical University of Graz
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2014-01
|
| Completion Date: |
2016-03
|
| Results First Posted: |
|
| Last Update Posted: |
2016-09-12
|
| Locations: |
Medical University of Graz, Graz, Styria, 8036, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT02028078
|
