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

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ClinicalTrials.gov Identifier: NCT03862690
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: BIAsp 30

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Study Type : Observational
Estimated Enrollment : 918 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : September 26, 2019
Estimated Primary Completion Date : July 17, 2020
Estimated Study Completion Date : July 17, 2020

Resource links provided by the National Library of Medicine


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 Name: NovoMix®




Primary Outcome Measures :
  1. Change in glycosylated haemoglobin A1c (HbA1c) [ Time Frame: From baseline (week 0) to end of study (week 24) ]
    Measured in % point.


Secondary Outcome Measures :
  1. Participants achieving HbA1c below 7.0% [ Time Frame: At end of study (week 24) ]
    Number of participants achieving HbA1c less than 7.0% at end of study (week 24) (yes/no).

  2. Particpants achieving HbA1c below 7.5% [ Time Frame: At end of study (week 24) ]
    Number of participants achieving HbA1c less than 7.5% at end of study (week 24) (yes/no).

  3. Partcipants achieving HbA1c below 8.0% [ Time Frame: At end of study (week 24) ]
    Number of participants achieving HbA1c less than 8.0% at end of study (week 24) (yes/no).

  4. Change in rate of severe hypoglycaemia [ Time Frame: From baseline (week 0) to end of study visit (as recalled at week 24) ]
    Measured in episodes/person-year.

  5. Change in total insulin dose [ Time Frame: From baseline (week 0) to end of study (week 24) ]
    Measured in units/day.

  6. Change in Diabetes Treatment Satisfaction (DTSQ) score [ Time Frame: 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.

  7. Change in health-related quality of life (EQ-5D) [ Time Frame: 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862690


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Algeria
Novo Nordisk Investigational Site Not yet recruiting
Algiers, Algeria, P.C. 16000, Hydra
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure 1452 Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03862690     History of Changes
Other Study ID Numbers: BIASP-4439
U1111-1208-5168 ( Other Identifier: World Health Organization (WHO) )
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: https://www.novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs