Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 50-50-30 | Experimental | Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin |
|
| BIAsp 30-30 | Active Comparator | Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin A1c (HbA1c) | Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16) | week 0, week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Achieving HbA1c Treatment Targets | The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%. | week 16 |
| Change and Daily Average in 8-point Plasma Glucose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Eligible subjects were subjects with type 2 diabetes having an HbA1c (Glycosylated Haemoglobin A1c) between 7.5-12.0 %, and treated with premix human insulin twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months qualifying for an intensified insulin treatment.
15 sites in China
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BIAsp 50-50-30 | Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily |
| FG001 | BIAsp 30-30 | Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BIAsp 50-50-30 | Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily |
| BG001 | BIAsp 30-30 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at screening |
| 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 A1c (HbA1c) | Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16) | Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product. | Posted | Least Squares Mean | Standard Error | percentage (%) of total haemoglobin | week 0, week 16 |
|
Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIAsp 50-50-30 | Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemic coma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
Not provided
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| metformin | Drug | Tablets, 500 - 2000 mg, once, twice or three times daily |
|
| biphasic insulin aspart 50 | Drug | Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch |
|
Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment. |
| week 0, week 16 |
| Change and Daily Average in Prandial Plasma Glucose Increment | Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment. | week 0, week 16 |
| The Total Increase in Total Daily Insulin Dose Per Body Weight | The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16). | week 0, week 16 |
| Change in Body Weight | Change in body weight from baseline (week 0) to end of treatment (week 16) | week 0, week 16 |
| Number of Hypoglycaemic Episodes | Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. 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 |
| Number of Nocturnal Hypoglycaemic Episodes | Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. 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 |
| Other |
|
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | BMI = Body Mass Index at randomisation | Mean | Standard Deviation | kg/m2 |
|
| Height | Height at screening | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|
| Secondary | The Percentage of Subjects Achieving HbA1c Treatment Targets | The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%. | Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product. | Posted | Number | percentage (%) of subjects | week 16 |
|
|
|
| Secondary | Change and Daily Average in 8-point Plasma Glucose | Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment. | Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product. | Posted | Least Squares Mean | Standard Error | mmol/L | week 0, week 16 |
|
|
|
| Secondary | Change and Daily Average in Prandial Plasma Glucose Increment | Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment. | Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product. | Posted | Least Squares Mean | Standard Error | mmol/L | week 0, week 16 |
|
|
|
| Secondary | The Total Increase in Total Daily Insulin Dose Per Body Weight | The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16). | Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product. | Posted | Least Squares Mean | Standard Error | U/kg | week 0, week 16 |
|
|
|
| Secondary | Change in Body Weight | Change in body weight from baseline (week 0) to end of treatment (week 16) | Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product. | Posted | Least Squares Mean | Standard Error | kg | week 0, week 16 |
|
|
|
| Secondary | Number of Hypoglycaemic Episodes | Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. 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. | Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product. | Posted | Number | episodes | weeks 0-16 |
|
|
|
| Secondary | Number of Nocturnal Hypoglycaemic Episodes | Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. 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. | Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product. | Posted | Number | episodes | weeks 0-16 |
|
|
|
| 5 |
| 219 |
| 74 |
| 219 |
| EG001 | BIAsp 30-30 | Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily | 9 | 222 | 68 | 222 |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intestinal mucosal hypertrophy | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Vertebral injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Albumin urine present | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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.
| Before Lunch, N= 213, 210 |
|
| 2 hours After Lunch, N= 213, 211 |
|
| Before Dinner, N= 212, 212 |
|
| 2 hours After Dinner, N= 211, 209 |
|
| Bedtime, N= 207, 207 |
|
| 3:00 AM, N= 211, 210 |
|
| Average, N= 213, 212 |
|
| At Dinner, N= 210, 209 |
|
| Average, N= 213, 211 |
|
| Minor |
|
| Symptoms Only |
|
| Minor |
|
| Symptons Only |
|