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This trial is conducted in Europe.
This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 | Experimental | Biphasic insulin aspart 30 administered once daily for 16 weeks. If HbA1c is higher than 7.0 % after 16 weeks of treatment, dose is increased to twice daily for another 16 weeks. If HbA1c is higher than 7.0 % after 32 weeks of treatment, dose is increased to three times daily until week 48 (end of trial). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart | Drug | Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | week 48 | |
| Number of Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul | 343662 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Eligible subjects were those with type 2 diabetes inadequately controlled with oral anti-diabetic drugs (OADs) with or without basal insulin therapy.
One single site in Turkey
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| ID | Title | Description |
|---|---|---|
| FG000 | BIAsp 30 | Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | BIAsp 30 | Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug. | Posted | Number | percentage of subjects | week 48 |
|
Adverse events were collected over a time span of 48 weeks.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIAsp 30 | Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood cholesterol increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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| weeks 0-48 |
| Number of Diurnal Hypoglycaemic Episodes | Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. | weeks 0-48 |
| Number of Nocturnal Hypoglycaemic Episodes | Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. | weeks 0-48 |
| Number of Treatment Emergent Serious Adverse Events (SAEs) | Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period. | weeks 0-48 |
| Protocol Violation |
|
| Unclassified |
|
| Inability to tolerate trial medication |
|
| Non-compliance with trial procedures |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes Duration | Number of years since diagnosis | Mean | Standard Deviation | years |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug. | Posted | Number | percentage of trial completers | week 48 |
|
|
|
| Secondary | Number of Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. | Safety analysis set was all subjects who have been exposed to at least one dose of trial drug. | Posted | Number | episodes | weeks 0-48 |
|
|
|
| Secondary | Number of Diurnal Hypoglycaemic Episodes | Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. | Safety analysis set was all subjects who have been exposed to at least one dose of trial drug. | Posted | Number | episodes | weeks 0-48 |
|
|
|
| Secondary | Number of Nocturnal Hypoglycaemic Episodes | Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. | Safety analysis set was all subjects who have been exposed to at least one dose of trial drug. | Posted | Number | episodes | weeks 0-48 |
|
|
|
| Secondary | Number of Treatment Emergent Serious Adverse Events (SAEs) | Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period. | Safety analysis set was all subjects who have been exposed to at least one dose of trial drug. | Posted | Number | events | weeks 0-48 |
|
|
|
| 5 |
| 160 |
| 44 |
| 160 |
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Toxic nodular goitre | Endocrine disorders | MedDRA (12.0) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
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