| Trial ID: | L2072 |
| Source ID: | NCT02147431
|
| Associated Drug: |
Semaglutide
|
| Title: |
A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: semaglutide|DRUG: placebo
|
| Outcome Measures: |
Primary: Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L)), After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213) | Secondary: Change in mean glucagon concentration from target level 5.5 mmol/L to 3.5 mmoL/L and from ambient plasma glucose to target levels 5.5 mmol/L, 3.5 mmol/L and nadir, After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)|Change in mean concentrations of adrenaline, noradrenaline, cortisol and growth hormone from target level 5.5 mmol/L to 3.5 mmol/L and to nadir, After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)|Hypoglycaemic symptoms score, After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)|Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L, After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-05-21
|
| Completion Date: |
2015-05-20
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| Results First Posted: |
|
| Last Update Posted: |
2018-08-13
|
| Locations: |
Novo Nordisk Investigational Site, Graz, 8010, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT02147431
|
