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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1118-0330 | Other Identifier | WHO |
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This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 (2:1) | Experimental | After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals |
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| BIAsp 30 (1:1) | Experimental | After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline | Week 0, week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 9-point SMPG (Self Measured Plasma Glucose) Profile | A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day | Week 16 |
| Percentage of Subjects Achieving HbA1c Below 7.0% |
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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 |
|---|---|---|---|---|---|---|
| Beijing | Beijing Municipality | 100029 | China |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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All subjects who completed the 24 week treatment and did not achieve the target of glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIAsp-3756 (NCT01123980) were offered the possibility to go into BIAsp-3883. Subjects continued their previous treatment unchanged from trial BIASP-3756 and throughout the one-week screening period.
This trial was conducted at 20 sites in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | BIAsp 30 (2:1) | After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| biphasic insulin aspart 30 | Drug | Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin. |
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| metformin | Drug | Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged |
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The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment |
| Week 16 |
| Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% | The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment | Week 16 |
| Number of Treatment Emergent Hypoglycaemic Episodes | Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included). | Weeks 0-16 |
| FG001 | BIAsp 30 (1:1) | After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals |
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| ID | Title | Description |
|---|---|---|
| BG000 | BIAsp 30 (2:1) | After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals |
| BG001 | BIAsp 30 (1:1) | After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals |
| 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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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Glycosylated haemoglobin (HbA1c) at screening | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
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| Duration of diabetes | Number of years since diagnosis | Mean | Standard Deviation | years |
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| Diabetic complications | Number | participants |
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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 A1c (HbA1c) From Baseline | Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). Six patients discontinued trial without any post randomisation HbA1c measurements. | Posted | Least Squares Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, week 16 |
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| Secondary | 9-point SMPG (Self Measured Plasma Glucose) Profile | A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day | Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). | Posted | Least Squares Mean | Standard Error | mmol/L | Week 16 |
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| Secondary | Percentage of Subjects Achieving HbA1c Below 7.0% | The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment | Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). | Posted | Number | percentage of subjects | Week 16 |
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| Secondary | Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% | The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment | Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). | Posted | Number | percentage of subjects | Week 16 |
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| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes | Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included). | Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). | Posted | Number | episodes | Weeks 0-16 |
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The adverse events were collected in a timespan of 17 weeks.
The safety analysis set contained all subjects exposed to at least one dose of investigational products.
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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 (2:1) | After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals | 1 | 89 | 0 | 89 | ||
| EG001 | BIAsp 30 (1:1) | After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals | 2 | 90 | 0 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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Novo Nordisk reserves the right to not release data until specified milestones, e.g. when the clinical trial report is available. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
| 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 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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