| Trial ID: | L5274 |
| Source ID: | NCT01868542
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| Associated Drug: |
Insulin Detemir
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| Title: |
A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs)
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01868542/results
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| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: insulin detemir
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| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline., Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included., Week 0, week 20 | Secondary: Change in HbA1c, Change in HbA1c at 12 weeks of treatment from visit 2., Week 0, week 12|Proportion of Subjects Achieving HbA1c Below 7.0%, Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c \< 7.0% at end of trial) during 20 weeks of treatment., Week 20|Change in Fasting Plasma Glucose From Baseline, Change in fasting plasma glucose from baseline., week 0, week 12|Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours., A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms., For 20 weeks of treatment and over 24 hours|Change in Fasting Plasma Glucose From Baseline, Change in fasting plasma glucose from baseline., Week 0, week 20|Incidence of Adverse Events, A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20), Week 20
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| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
46
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2013-06
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| Completion Date: |
2015-05
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| Results First Posted: |
2016-06-29
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| Last Update Posted: |
2017-03-03
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| Locations: |
Novo Nordisk Investigational Site, Daejeon, 301-721, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 301-723, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 302-120, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 302-718, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 330-721, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 361-711, Korea, Republic of
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| URL: |
https://clinicaltrials.gov/show/NCT01868542
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