| Trial ID: | L5241 |
| Source ID: | NCT00964964
|
| Associated Drug: |
Insulin Degludec
|
| Title: |
A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: insulin degludec|DRUG: insulin degludec|DRUG: placebo
|
| Outcome Measures: |
Primary: Total number of periods where carbohydrate supplementation is needed during the treatment, Assessed every day of the two in-house stays of nine days | Secondary: Frequency of adverse events (AEs), Assessed every day of the two in-house stays of nine days and one follow-up by telephone|Number of periods with low blood sugar during treatment, Assessed every day of the two in-house stays of nine days and one follow-up by telephone
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-08
|
| Completion Date: |
2009-09
|
| Results First Posted: |
|
| Last Update Posted: |
2013-11-27
|
| Locations: |
Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00964964
|
