A Research Study, Looking at How NovoMix® Works in People With Type 2 Diabetes in Local Clinical Practice in Algeria (B Simple)
|ClinicalTrials.gov Identifier: NCT03862690|
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Drug: BIAsp 30|
|Study Type :||Observational|
|Estimated Enrollment :||918 participants|
|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|
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®
- Change in glycosylated haemoglobin A1c (HbA1c) [ Time Frame: From baseline (week 0) to end of study (week 24) ]Measured in % point.
- 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).
- 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).
- 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).
- 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.
- Change in total insulin dose [ Time Frame: From baseline (week 0) to end of study (week 24) ]Measured in units/day.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862690
|Contact: Novo Nordisk||(+1) email@example.com|
|Novo Nordisk Investigational Site||Not yet recruiting|
|Algiers, Algeria, P.C. 16000, Hydra|
|Study Director:||Clinical Reporting Anchor and Disclosure 1452||Novo Nordisk A/S|