| Trial ID: | L3020 |
| Source ID: | NCT03823339
|
| Associated Drug: |
Insulin Degludec/Liraglutide
|
| Title: |
A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates
|
| Acronym: |
INTENSIFY
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin degludec/liraglutide
|
| Outcome Measures: |
Primary: Change in laboratory measured glycosylated haemoglobin A1c (HbA1c), Measured in % point, From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) | Secondary: Patients reached HbA1c less than 7% at end of study (Yes/No ), Number of patients who achieved/not achieved HbA1c at end of study: \<7.0%, At the end of study visit (26-34 weeks)|Change in laboratory measured fasting plasma glucose (FPG), Measured in mg/dL, From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)|Average dose step of Xultophy® at end of the study, Measured in dose steps/day, At the end of study (26-34 weeks)|Change of body weight, Measured in kg, From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)|Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection, Number of episodes, Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)|Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection, Number of episodes, Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)|Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall), Number of episodes, Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks)|Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable, Pre-specified response option(s), At the end of study (26-34 weeks)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
300
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2019-01-29
|
| Completion Date: |
2020-12-14
|
| Results First Posted: |
|
| Last Update Posted: |
2021-09-22
|
| Locations: |
Novo Nordisk Investigational Site, AbuDhabi, United Arab Emirates|Novo Nordisk Investigational Site, Ajman, 4184, United Arab Emirates|Novo Nordisk Investigational Site, Dubai, United Arab Emirates
|
| URL: |
https://clinicaltrials.gov/show/NCT03823339
|
