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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1137-2342 | Other Identifier | WHO |
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This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 (Group A) | Experimental | Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2) |
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| Treatment sequence 2 (Group B) | Experimental | Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 50 | Drug | Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test | The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value. | After 4 weeks of treatment in each treatment sequence |
| Measure | Description | Time Frame |
|---|---|---|
| -1-hour PPG Increment Following a Standard Meal Test | The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value. | After 4 weeks of treatment in each treatment sequence |
| -IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test |
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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 | 100034 | China |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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There were no significant events following enrolment of subjects, and prior to randomization.
This trial was conducted in 14 sites in one country (China).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (BIAsp 50 - BHI 50) | In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| biphasic human insulin 50 | Drug | Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin. |
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AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model. |
| After 4 weeks of treatment in each treatment sequence |
| 2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile | PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal. | After 4 weeks of treatment in each treatment sequence |
| The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile | Mean post prandial PG increment over all meals was derived as the mean of all available meal increments. | After 4 weeks of treatment in each treatment sequence |
| Incidence of Hypoglycemic Episodes | Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia. | During 4 weeks of treatment in each treatment sequence |
| Incidence of AEs (Adverse Event) | Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. | During 4 weeks of treatment in each treatment sequence |
| FG001 | Group B (BHI 50 - BIAsp 50) | In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group B received BHI 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG). |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). Group B received BHI 50 BID during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG). |
| 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 | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 | 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test | The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value. | Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements. | Posted | Mean | Standard Deviation | mmol/L | After 4 weeks of treatment in each treatment sequence |
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| Secondary | -1-hour PPG Increment Following a Standard Meal Test | The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value. | Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 8 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements. | Posted | Mean | Standard Deviation | mmol/L | After 4 weeks of treatment in each treatment sequence |
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| Secondary | -IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test | AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model. | Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements. | Posted | Mean | Standard Deviation | min*mmol/L | After 4 weeks of treatment in each treatment sequence |
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| Secondary | 2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile | PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal. | Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Subjects were excluded from analysis due to lack of post-randomization measurements. See table. | Posted | Least Squares Mean | Standard Error | mmol/L | After 4 weeks of treatment in each treatment sequence |
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| Secondary | The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile | Mean post prandial PG increment over all meals was derived as the mean of all available meal increments. | Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Four (4) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements. | Posted | Least Squares Mean | Standard Error | mmol/L | After 4 weeks of treatment in each treatment sequence |
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| Secondary | Incidence of Hypoglycemic Episodes | Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia. | Safety analysis set included all subjects receiving at least one dose of investigational products. | Posted | Number | events per patient per year | During 4 weeks of treatment in each treatment sequence |
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| Secondary | Incidence of AEs (Adverse Event) | Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. | Safety analysis set included all subjects receiving at least one dose of investigational products. | Posted | Number | Events/100 years of patient exposure | During 4 weeks of treatment in each treatment sequence |
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An event with onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment was defined as treatment emergent AE. All events meeting this definition were collected and reported.
Safety analysis set included all subjects receiving 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 50 | This arm included the subjects received BIAsp 50. | 1 | 155 | 8 | 155 | ||
| EG001 | BHI 50 | This arm included the subjects received BHI 50. | 1 | 158 | 2 | 158 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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Authorship of publications should be in accordance with the Uniform Requirements of the International Committee of Medical Journal Editors. The Investigators offered authorship will be asked to comment and approve the publication. No permission to publish will be granted to any clinical research organization involved in the trial described in trial 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 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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