Clinical Trial Details
| Trial ID: | L3063 |
| Source ID: | NCT01697657 |
| Associated Drug: | Insulin Detemir |
| Title: | Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes|Diabetes Mellitus, Type 1 |
| Interventions: | DRUG: insulin detemir|DRUG: insulin NPH|DRUG: insulin aspart |
| Outcome Measures: | Primary: Incidence of total self-recorded hypoglycaemic episodes | Secondary: Incidence of total major hypoglycaemic episodes|HbA1c (glycosylated haemoglobin)|8-point plasma glucose profiles|Serum glucose profiles|72-hours glucose profile|Within-subject variation in home-measured fasting plasma glucose|Incidence of adverse events |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 131 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2001-09 |
| Completion Date: | 2002-11 |
| Results First Posted: | |
| Last Update Posted: | 2017-01-27 |
| Locations: | Novo Nordisk Investigational Site, Camperdown, New South Wales, 2050, Australia|Novo Nordisk Investigational Site, Ashford, 5035, Australia|Novo Nordisk Investigational Site, Box Hill, 3128, Australia|Novo Nordisk Investigational Site, Zagreb, 10 000, Croatia|Novo Nordisk Investigational Site, Køge, 4600, Denmark|Novo Nordisk Investigational Site, Århus C, 8000, Denmark|Novo Nordisk Investigational Site, Citta' Di Castello, 06012, Italy|Novo Nordisk Investigational Site, Perugia, 06126, Italy|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7925, South Africa|Novo Nordisk Investigational Site, Linköping, 581 85, Sweden|Novo Nordisk Investigational Site, Trelleborg, 231 85, Sweden |
| URL: | https://clinicaltrials.gov/show/NCT01697657 |

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