Clinical trial NCT03862690: A Research Study, Looking at How NovoMix® Works in People With Type 2 Diabetes in Local Clinical Practice in Algeria
Official title: A Prospective Non-interventional Study Investigating the Treatment Effect of NovoMix® 30 (Biphasic Insulin Aspart 30) in a Real World Adult Population With Type 2 Diabetes in Algeria
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-03-05
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes mellitus, previously treated with basal insulin plus 1-3 bolus insulin injections per day for at least 24 weeks prior to the study,

Brief summary: The purpose of the study is to collect information about how NovoMix® 30 works in real world adult population with type 2 diabetes. Participants will get NovoMix® 30 as prescribed by the study doctor. The study will last for about 6-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their study doctor's appointment.


Eligibility criteria: Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate treatment with commercially available NovoMix® 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
* Male or female, greater than or equal to 19 years at the time of signing informed consent
* Diagnosed with type 2 diabetes and treated with basal insulin plus 1-3 bolus insulin injections per day for at least 24 weeks prior to informed consent
* Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of NovoMix® 30 treatment

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Participation in any clinical trial of an approved or non- approved investigational medicinal product within 24 weeks prior to initiation of NovoMix® 30 treatment. Clinical trials do not include non-interventional studies
* Hypersensitivity to NovoMix® 30 or to any of the excipients
* Pregnancy or intention of becoming pregnant

Primary outcomes:
measure: Change in glycosylated haemoglobin A1c (HbA1c)
timeFrame: From baseline (week 0) to end of study (week 24)
Secondary outcomes:
measure: Participants achieving HbA1c below 7.0%
timeFrame: At end of study (week 24)
measure: Particpants achieving HbA1c below 7.5%
timeFrame: At end of study (week 24)
measure: Partcipants achieving HbA1c below 8.0%
timeFrame: At end of study (week 24)
measure: Change in rate of severe hypoglycaemia
timeFrame: From baseline (week 0) to end of study visit (as recalled at week 24)
measure: Change in total insulin dose
timeFrame: From baseline (week 0) to end of study (week 24)
measure: Change in Diabetes Treatment Satisfaction (DTSQ) score
timeFrame: From baseline (week 0) to end of study (week 24)
measure: Change in health-related quality of life (EQ-5D)
timeFrame: From baseline (week 0) to end of study (week 24)
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Novo Nordisk Investigational Site
city: Constantine
country: Algeria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure 1452
role: STUDY_DIRECTOR
References: