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

Withdrawn

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BIAsp 30

• Registration Number: NCT03862690
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Study Start: 2020-05-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20
• Primary Completion: 2021-06-28
• Study Completion: 2021-06-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Type 2 Diabetes Mellitus	BIAsp 30	A broad adult population of patients with type 2 diabetes (T2D) requiring insulin therapy in different basal-bolus treatment regimens.

Primary Outcome Measures

Name	Time	Method
Change in glycosylated haemoglobin A1c (HbA1c)	From baseline (week 0) to end of study (week 24)	Measured in % point.

Secondary Outcome Measures

Name	Time	Method
Change in Diabetes Treatment Satisfaction (DTSQ) score	From baseline (week 0) to end of study (week 24)	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.
Change in health-related quality of life (EQ-5D)	From baseline (week 0) to end of study (week 24)	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.
Participants achieving HbA1c below 7.0%	At end of study (week 24)	Number of participants achieving HbA1c less than 7.0% at end of study (week 24) (yes/no).
Particpants achieving HbA1c below 7.5%	At end of study (week 24)	Number of participants achieving HbA1c less than 7.5% at end of study (week 24) (yes/no).
Partcipants achieving HbA1c below 8.0%	At end of study (week 24)	Number of participants achieving HbA1c less than 8.0% at end of study (week 24) (yes/no).
Change in rate of severe hypoglycaemia	From baseline (week 0) to end of study visit (as recalled at week 24)	Measured in episodes/person-year.
Change in total insulin dose	From baseline (week 0) to end of study (week 24)	Measured in units/day.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇿 Constantine, Algeria