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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1208-5168 | Other Identifier | World Health Organization (WHO) |
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Sponsor decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIAsp 30 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycosylated haemoglobin A1c (HbA1c) | Measured in % point. | From baseline (week 0) to end of study (week 24) |
| 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% |
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Inclusion Criteria:
Exclusion Criteria:
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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,
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure 1452 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Algiers | P.C. 16000, Hydra | Algeria | |||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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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) |
| Constantine |
| 25000 |
| Algeria |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |