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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: BIAsp 30

• Study Type: Observational

Contacts and Locations

Study Locations

• Algeria
  • Algiers, Algeria, P.C. 16000, Hydra
    • Novo Nordisk Investigational Site
  • Constantine, Algeria, 25000
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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,

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.; Other Names: NovoMix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycosylated haemoglobin A1c (HbA1c)	Measured in % point.	From baseline (week 0) to end of study (week 24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
Change in total insulin dose	Measured in units/day.	From baseline (week 0) to end of study (week 24)
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)
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 28, 2020
• Primary Completion (ANTICIPATED): June 28, 2021
• Study Completion (ANTICIPATED): June 28, 2021

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (ACTUAL): March 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin aspart, insulin aspart protamine drug combination 30:70
• Other Study ID Numbers: BIASP-4439; U1111-1208-5168 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No