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Clinical Trial Details

Trial ID: L5206
Source ID: NCT03862690
Associated Drug: Biasp 30
Title: A Research Study, Looking at How NovoMix® Works in People With Type 2 Diabetes in Local Clinical Practice in Algeria
Acronym: B Simple
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BIAsp 30
Outcome Measures: Primary: Change in glycosylated haemoglobin A1c (HbA1c), Measured in % point., From baseline (week 0) to end of study (week 24) | Secondary: Participants achieving HbA1c below 7.0%, Number of participants achieving HbA1c less than 7.0% at end of study (week 24) (yes/no)., At end of study (week 24)|Particpants achieving HbA1c below 7.5%, Number of participants achieving HbA1c less than 7.5% at end of study (week 24) (yes/no)., At end of study (week 24)|Partcipants achieving HbA1c below 8.0%, Number of participants achieving HbA1c less than 8.0% at end of study (week 24) (yes/no)., At end of study (week 24)|Change in rate of severe hypoglycaemia, Measured in episodes/person-year., From baseline (week 0) to end of study visit (as recalled at week 24)|Change in total insulin dose, Measured in units/day., From baseline (week 0) to end of study (week 24)|Change in Diabetes Treatment Satisfaction (DTSQ) score, The DTSQs is a self-completion questionnaire used to assess subject's treatment satisfaction. The DTSQ total score will be based on item 1 and 4-8, which are scored on a scale from 0 to 36, a higher score related to a better perception of treatment satisfaction. Items 2 and 3 will be reported separately on a scale from 0 to 6 as per instruction in the DTSQs manual., From baseline (week 0) to end of study (week 24)|Change in health-related quality of life (EQ-5D), The EQ-5D questionnaire will be used to assess subject's health-related quality of life. This instrument contains 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and measures 5 levels of severity (no problems, slight problems, moderate problems, severe problems and extreme problems). The EQ visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical VAS with scores 0-100., From baseline (week 0) to end of study (week 24)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 0
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2020-05-28
Completion Date: 2021-06-28
Results First Posted:
Last Update Posted: 2020-07-20
Locations: Novo Nordisk Investigational Site, Algiers, P.C. 16000, Hydra, Algeria|Novo Nordisk Investigational Site, Constantine, 25000, Algeria
URL: https://clinicaltrials.gov/show/NCT03862690

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D174 Bisoprolol small molecule DB00612 Details