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This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30-30 | Experimental | Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Subcutaneous (under the skin) injection, twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (Glycosylated Haemoglobin A1c) | Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment) | week 0, week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 8-point Plasma Glucose Profile | Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment | week 0, week 16 |
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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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Eligible subjects, treated with basal insulin, stopped their oral anti-diabetic drug treatment and started a run-in period of forced metformin titration. Subjects on current metformin therapy could go through a modified titration. Doses were up-titrated weekly until either the max tolerated dose of at least 1500mg/day or a max dose of 2000mg/day.
22 sites in China
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| ID | Title | Description |
|---|---|---|
| FG000 | BIAsp 30-30 | Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| metformin | Drug | Tablets, 1000 - 2000 mg daily |
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| Percentage of Subjects Achieving HbA1c Less Than 7.0% |
Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment |
| week 16 |
| Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% | Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment | week 16 |
| Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). 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 was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. | weeks 0-16 |
| Hypoglycaemic Episodes, Diurnal/Nocturnal | Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal). | weeks 0-16 |
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| ID | Title | Description |
|---|---|---|
| BG000 | BIAsp 30-30 | Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily |
| 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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| Previous treatment | Number | Participants |
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| BMI | BMI (Body Mass Index) measured at baseline (week 0) | Mean | Standard Deviation | kg/m^2 |
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| Duration of diabetes | Number of years since diagnosis | Mean | Standard Deviation | Years |
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| HbA1c | HbA1c (Glycosylated Haemoglobin A1c) at baseline (week 0) | Mean | Standard Deviation | percentage (%) of total haemoglobin |
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| Weight | Weight measured at baseline (week 0) | Mean | Standard Deviation | kg |
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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 HbA1c (Glycosylated Haemoglobin A1c) | Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment) | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | Mean | Standard Error | percentage (%) of total haemoglobin | week 0, week 16 |
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| Secondary | Change in 8-point Plasma Glucose Profile | Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | Mean | Standard Error | mg/dL | week 0, week 16 |
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| Secondary | Percentage of Subjects Achieving HbA1c Less Than 7.0% | Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment | Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | Number | percentage of participants | week 16 |
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| Secondary | Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% | Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment | Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | Number | percentage of participants | week 16 |
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| Secondary | Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). 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 was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. | Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | Number | episodes | weeks 0-16 |
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| Secondary | Hypoglycaemic Episodes, Diurnal/Nocturnal | Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal). | Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | Number | episodes | weeks 0-16 |
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The adverse events were collected in a time span of 16 weeks.
Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of 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 | BIAsp 30-30 | Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily | 0 | 293 | 80 | 293 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Coronary Artery Disease | Cardiac disorders | MedDRA | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastric dilatation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Periodontitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA | Systematic Assessment |
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| Oedema | General disorders | MedDRA | Systematic Assessment |
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| Pain | General disorders | MedDRA | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
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| Blood triglycerides abnormal | Investigations | MedDRA | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
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| Electrocardiogram ST segment depression | Investigations | MedDRA | Systematic Assessment |
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| Electrocardiogram ST-T segment abnormal | Investigations | MedDRA | Systematic Assessment |
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| Electrocardiogram T wave abnormal | Investigations | MedDRA | Systematic Assessment |
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| Lipids abnormal | Investigations | MedDRA | Systematic Assessment |
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| Lipids increased | Investigations | MedDRA | Systematic Assessment |
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| Low density lipoprotein abnormal | Investigations | MedDRA | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Lipid metabolism disorder | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Vascular headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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This single-armed trial does not permit a comprehensive comparison between BIAsp30 and basal insulin. Otherwise, this could have proffered greater clarity on the putative benefits that BIAsp30 brings to subjects with type 2 diabetes.
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. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
| 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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| 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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| Animal insulin |
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