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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-2121 | Other Identifier | WHO |
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This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-breakfast BIAsp 30 | Experimental |
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| Pre-dinner BIAsp 30 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11 | Estimated mean change from baseline in HbA1c after 11 weeks of treatment | Week 0, Week 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36 | Estimated mean change from baseline in FPG after 36 weeks of treatment | Week 0, Week 36 |
| Number of Treatment Emergent Hypoglycaemic Episodes |
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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 |
|---|---|---|---|---|---|---|
| Tehran | Iran |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects were on a stable antidiabetic regimen which includes a minimum of 2 OADs, daily for at least 3 months prior to screening. OAD doses were at least 50 percent of the maximum recommended dose.
The trial was conducted at 5 sites in Iran
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-breakfast BIAsp 30 | Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| biphasic insulin aspart 30 | Drug | Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms |
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A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.
| Week 0 to Week 36 |
| FG001 | Pre-dinner BIAsp 30 | Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-breakfast BIAsp 30 | Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels. |
| BG001 | Pre-dinner BIAsp 30 | Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
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| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mg/dL |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11 | Estimated mean change from baseline in HbA1c after 11 weeks of treatment | Full analysis set (FAS) includes all randomised subjects and missing data was imputed using baseline observation carried forward (BOCF) | Posted | Mean | Standard Error | percentage of glycosylated haemoglobin | Week 0, Week 11 |
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| Secondary | Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36 | Estimated mean change from baseline in FPG after 36 weeks of treatment | Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | mg/dL | Week 0, Week 36 |
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| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes | A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product. | Safety analysis set includes all subjects who received at least one dose of the trial product. | Posted | Number | episodes | Week 0 to Week 36 |
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The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
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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 | Pre-breakfast BIAsp 30 | Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels. | 3 | 122 | 16 | 122 | ||
| EG001 | Pre-dinner BIAsp 30 | Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels. | 4 | 123 | 19 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| 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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