A Research Study, Looking at How NovoMix® Works in People With Type 2 Diabetes in Local Clinical Practice in Algeria

Diabetes Mellitus, Type 2 Clinical Trial

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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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03862690
• Other study ID #: BIASP-4439
• Secondary ID: U1111-1208-5168
• Status: Withdrawn
• Start date: May 28, 2020
• Est. completion date: June 28, 2021

Study information

• Verified date: July 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• BIAsp 30
Participants will receive commercially available BIAsp 30 once daily (QD), twice daily (BID) or thrice daily (TID) for 24 weeks according to routine clinical practice. The physician will determine the starting dose and any potential later change to the dose. The decision to switch the patient to NovoMix® 30 is at the treating physician's discretion and independent from the decision to include the patient in the study.

Locations

Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Algiers
Algeria	Novo Nordisk Investigational Site	Constantine

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Algeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in total insulin dose	Measured in units/day.	From baseline (week 0) to end of study (week 24)
Secondary	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)
Secondary	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)