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Clinical Trial Details

Trial ID: L4105
Source ID: NCT00455858
Associated Drug: Insulin Detemir
Title: Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00455858/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir
Outcome Measures: Primary: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20, Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20, week 0, week 20 | Secondary: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12, Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline, week 0, week 12|Change in Fasting Plasma Glucose (FPG), Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20, week 0, week 12, week 20|Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%, Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%, week 12, week 20|Occurence of Hypoglycaemic Episodes, Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment., weeks 0-20
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 87
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-11
Completion Date: 2008-10
Results First Posted: 2010-02-23
Last Update Posted: 2024-02-01
Locations: Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT00455858