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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-4112 | Other Identifier | WHO | |
| JapicCTI-101139 | Other Identifier | JAPIC |
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This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.
The trial is conducted as a phase 4 trial in China and phase 3 in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 | Experimental | 0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride |
|
| Insulin glargine | Active Comparator | 0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Week 0, week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 9-point Plasma Glucose Profiles | Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day. | Week 24 |
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100029 | China | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23998560 | Result | Yang W, Xu X, Liu X, Yang G, Seino Y, Andersen H, Jinnouchi H. Treat-to-target comparison between once daily biphasic insulin aspart 30 and insulin glargine in Chinese and Japanese insulin-naive subjects with type 2 diabetes. Curr Med Res Opin. 2013 Dec;29(12):1599-608. doi: 10.1185/03007995.2013.838155. Epub 2013 Sep 23. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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At the screening, eligible subjects entered the run-in period before being randomised. During the 3 week run-in period, subjects switched from insulin secretagogue to glimepiride. During the last 2 weeks, the total dose of glimepiride was kept at 4mg/day. Subjects continued their pre-trial metformin dose.
The trial was conducted at 35 sites in two countries: China (21 sites) and Japan (14 sites).
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| ID | Title | Description |
|---|---|---|
| FG000 | BIAsp 30 | 0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride |
| FG001 | Insulin Glargine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| metformin | Drug | China: Tablets, 500 mg. Min. 1500 mg/day. Japan: Tablets, 250 mg. Min 500 mg/day. |
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| glimepiride | Drug | China: Tablets, 2 mg. Min. 4 mg/day. Japan: Tablets, 1 mg. Min. 4 mg/day. |
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| insulin glargine | Drug | Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily. |
|
| Percentage of Subjects Achieving HbA1c Below 7.0% | The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment | Week 24 |
| Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% | The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment | Week 24 |
| Number of Hypoglycaemic Episodes - All | Weeks 0-24 |
| Number of Hypoglycaemic Episodes - Severe and Minor | Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L. | Weeks 0-24 |
| Number of Hypoglycaemic Episodes | All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)). | Weeks 0-24 |
| Beijing |
| Beijing Municipality |
| 100101 |
| China |
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100191 | China |
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100700 | China |
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100853 | China |
| Novo Nordisk Investigational Site | Chongqing | Chongqing Municipality | 400010 | China |
| Novo Nordisk Investigational Site | Fuzhou | Fujian | 350025 | China |
| Novo Nordisk Investigational Site | Harbin | Heilongjiang | 150001 | China |
| Novo Nordisk Investigational Site | Zhengzhou | Henan | 450052 | China |
| Novo Nordisk Investigational Site | Nanjing | Jiangsu | 210012 | China |
| Novo Nordisk Investigational Site | Nanjing | Jiangsu | 210029 | China |
| Novo Nordisk Investigational Site | Wuxi | Jiangsu | 214023 | China |
| Novo Nordisk Investigational Site | Nanchang | Jiangxi | 330006 | China |
| Novo Nordisk Investigational Site | Dalian | Liaoning | 116011 | China |
| Novo Nordisk Investigational Site | Shenyang | Liaoning | 110004 | China |
| Novo Nordisk Investigational Site | Shenyang | Liaoning | 110021 | China |
| Novo Nordisk Investigational Site | Xi'an | Shaanxi | 710061 | China |
| Novo Nordisk Investigational Site | Tianjin | Tianjin Municipality | 300052 | China |
| Novo Nordisk Investigational Site | Tianjin | Tianjin Municipality | 300070 | China |
| Novo Nordisk Investigational Site | Shenyang | 110001 | China |
| Novo Nordisk Investigational Site | Tianjin | 300211 | China |
| Novo Nordisk Investigational Site | Asahikawa-shi, Hokkaido | 078 8510 | Japan |
| Novo Nordisk Investigational Site | Chuo-ku, Tokyo | 103 0002 | Japan |
| Novo Nordisk Investigational Site | Gifu City, Gifu | 5008717 | Japan |
| Novo Nordisk Investigational Site | Higashiku | 812 8582 | Japan |
| Novo Nordisk Investigational Site | Kumamoto-shi,Kumamoto | 862 0976 | Japan |
| Novo Nordisk Investigational Site | Minatoku | 108 0073 | Japan |
| Novo Nordisk Investigational Site | Osaka | 5300025 | Japan |
| Novo Nordisk Investigational Site | Osaka-shi, Osaka | 545 8586 | Japan |
| Novo Nordisk Investigational Site | Shimotsuka-gun | 321 0293 | Japan |
| Novo Nordisk Investigational Site | Shimotsuke-shi, Tochigi | 329 0433 | Japan |
| Novo Nordisk Investigational Site | Shizuoka | 424 0853 | Japan |
| Novo Nordisk Investigational Site | Tagajō-shi | 985 0852 | Japan |
| Novo Nordisk Investigational Site | Yokohama | 235 0045 | Japan |
0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BIAsp 30 | 0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride |
| BG001 | Insulin Glargine | 0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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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| Gender | 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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| HbA1c (glycosylated haemoglobin) at randomisation | 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 at baseline | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycosylated Haemoglobin (HbA1c) | Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of trial product(s) | Posted | Least Squares Mean | Standard Error | percentage of glycosylated haemoglobin | Week 0, week 24 |
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| Secondary | 9-point Plasma Glucose Profiles | Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and 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 | Mean | Standard Error | mmol/L | Week 24 |
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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 after 24 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 24 |
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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 after 24 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 24 |
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| Secondary | Number of Hypoglycaemic Episodes - All | The safety analysis set contains all subjects exposed to at least one dose of investigational product(s). | Posted | Number | episodes | Weeks 0-24 |
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| Secondary | Number of Hypoglycaemic Episodes - Severe and Minor | Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L. | The safety analysis set contains all subjects exposed to at least one dose of investigational product(s). | Posted | Number | episodes | Weeks 0-24 |
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| Secondary | Number of Hypoglycaemic Episodes | All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)). | The safety analysis set contains all subjects exposed to at least one dose of investigational product(s). | Posted | Number | episodes | Weeks 0-24 |
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The adverse events were collected in a timespan of 24 weeks.
The safety analysis set contains 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 | 0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride | 2 | 261 | 26 | 261 | ||
| EG001 | Insulin Glargine | 0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride | 5 | 260 | 28 | 260 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery stenosis | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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Novo Nordisk reserves the right not to release data until specified milestones. This includes the right not to release interim results from clinical trials. At the end of the trial, one or more manuscripts for publication will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk will not suppress or veto publications; however Novo Nordisk reserves the right to postpone publication and/or communication for a short time 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 |
| C057619 | glimepiride |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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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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| Japan |
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| No |
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| Non-Inferiority or Equivalence |
Non-inferiority was considered to be confirmed if the upper bound of the two-sided 95% confidence interval (CI) was below or equal to 0.4% or equivalent if the p-value for the one-sided test of H0: D > 0.4% against HA: D =< 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (investigational product minus comparator). Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0% |
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