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Clinical Trial Details

Trial ID: L5598
Source ID: NCT03895515
Associated Drug: Fiasp®
Title: Effect of Fiasp® in Type 1 Diabetes Treatment
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Fiasp®
Outcome Measures: Primary: Change in percentage of time spent in glycaemic target range (TIR), Measured in percentage point. The change in percentage of TIR was defined as a blood glucose level of 3.9 to 10.0 mmol/L after initiation of Fiasp® treatment. Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment., Two-week period closest to and before index date, Two-week period closest to Week 26 | Secondary: Change in mean sensor glucose, Measured in mmol/L Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment., Two-week period closest to and before index date, Two-week period closest to Week 26|Change in glycaemic variability (GV) (measured as coefficient of variation [CV]), Measured in percentage point Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment., Two-week period closest to and before index date, Two-week period closest to Week 26|Change in percentage of time spent in level 1 hyperglycaemia (greater than 10.0 mmol/L), Measured in percentage point Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment., Two-week period closest to and before index date, Two-week period closest to Week 26|Change in percentage of time spent in level 2 hyperglycaemia (greater than 13.9 mmol/L), Measured in percentage point Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment., Two-week period closest to and before index date, Two-week period closest to Week 26|Change in percentage of time spent in level 2 hypoglycaemia (lesser than 3.0 mmol/L), Measured in percentage point Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment., Two-week period closest to and before index date, Two-week period closest to Week 26|Change in percentage of time spent in level 1 hypoglycaemia (lesser than 3.9 mmol/L), Measured in percentage point Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment., Two-week period closest to and before index date, Two-week period closest to Week 26|Proportion with CV lesser than 36%, Proportion of participants with/without GV corresponding to a CV lesser than 36% Time frame description: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment., Two-week period closest to Week 26|Change in Glycated Haemoglobin A1c (HbA1c), Measured in mmol/mol Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Measurement closest to Week 26 will be identified from a period ranging between 12 weeks after index date and 32 weeks after index date, Latest measurement between Week -12 and index date, measurement closest to Week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 178
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2020-01-03
Completion Date: 2020-12-21
Results First Posted:
Last Update Posted: 2022-04-07
Locations: Novo Nordisk Investigational Site, Stockholm, 141 86, Sweden
URL: https://clinicaltrials.gov/show/NCT03895515