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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003288-29 | EudraCT Number |
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This trial is conducted in Africa, Asia, Europe, Oceania and South America.
This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 | Experimental |
| |
| Glargine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart | Drug | Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Haemoglobin A1c (HbA1c) | Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment. | After 26 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 9-point Self-measured Plasma Glucose Profiles | Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points 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 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. 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. |
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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 | Buenos Aires | C1181ACH | Argentina | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19821654 | Result | Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674. | |
| 20363044 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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A screening period of 1-2 weeks was followed by a run-in period of 4 weeks during which metformin was titrated to maximum 2550 mg and glimepiride to 4 mg, at the discretion of the investigator. Subjects who were already taking 4, 6 or 8 mg glimepiride continued on this dose. Doses were kept constant during the last week prior to randomisation.
Subjects were enrolled 64 sites in 15 countries in Africa, Europe, Asia, North America and South America.
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| ID | Title | Description |
|---|---|---|
| FG000 | BIAsp 30 | Biphasic insulin aspart 30 + metformin + glimepiride |
| FG001 | Glargine | Insulin glargine + metformin + glimepiride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin glargine | Drug | Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. |
|
| metformin | Drug | Tablets, 2550 mcg. Administered once daily. |
|
| glimepiride | Drug | Tablets 2 mg. 4, 6 or 8 mg administered once daily. |
|
| After 26 weeks of treatment |
| Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c) | The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin. | After 26 weeks of treatment |
| Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat) | Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. | After 26 weeks of treatment |
| Number of Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced in each treatment arm. 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 0-26 |
| Number of Subjects Reporting Treatment Emergent Adverse Events | Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration. | Weeks 0-26 |
| Ciudad Autonoma de Bs As |
| C1405CWB |
| Argentina |
| Novo Nordisk Investigational Site | Ciudad Autónoma de BsAs | C1406FWY | Argentina |
| Novo Nordisk Investigational Site | Mar del Plata | B7602CBM | Argentina |
| Novo Nordisk Investigational Site | Bregenz | A - 6900 | Austria |
| Novo Nordisk Investigational Site | Feldkirch | 6807 | Austria |
| Novo Nordisk Investigational Site | Traisen | 3160 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1100 | Austria |
| Novo Nordisk Investigational Site | Wels | 4600 | Austria |
| Novo Nordisk Investigational Site | Brno | 656 91 | Czechia |
| Novo Nordisk Investigational Site | Hradec Králové | 500 05 | Czechia |
| Novo Nordisk Investigational Site | La Rochelle | 17019 | France |
| Novo Nordisk Investigational Site | Limoges | 87042 | France |
| Novo Nordisk Investigational Site | Mougins | 06250 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Nevers | 58033 | France |
| Novo Nordisk Investigational Site | Pointe à Pitre | 97159 | France |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | 380006 | India |
| Novo Nordisk Investigational Site | Karnāl | Haryana | 132001 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560043 | India |
| Novo Nordisk Investigational Site | Visakhapatnam | 530001 | India |
| Novo Nordisk Investigational Site | Cheras | 56000 | Malaysia |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Pulau Pinang | 10990 | Malaysia |
| Novo Nordisk Investigational Site | Guadalajara | 44600 | Mexico |
| Novo Nordisk Investigational Site | Guadalajara | 44620 | Mexico |
| Novo Nordisk Investigational Site | Pachuca | 42060 | Mexico |
| Novo Nordisk Investigational Site | Almere Stad | 1311RL | Netherlands |
| Novo Nordisk Investigational Site | Groningen | 9711 SG | Netherlands |
| Novo Nordisk Investigational Site | Leiderdorp | 2352 RA | Netherlands |
| Novo Nordisk Investigational Site | Rotterdam | 3021 HC | Netherlands |
| Novo Nordisk Investigational Site | Zoetermeer | 2724 EK | Netherlands |
| Novo Nordisk Investigational Site | Manila | 1014 | Philippines |
| Novo Nordisk Investigational Site | Quezon City | 1100 | Philippines |
| Novo Nordisk Investigational Site | Quezon City | 1102 | Philippines |
| Novo Nordisk Investigational Site | Bialystok | 15-276 | Poland |
| Novo Nordisk Investigational Site | Bydgoszcz | 85-094 | Poland |
| Novo Nordisk Investigational Site | Gdansk | 80-858 | Poland |
| Novo Nordisk Investigational Site | Gdynia | 81-366 | Poland |
| Novo Nordisk Investigational Site | Krakow | 31-501 | Poland |
| Novo Nordisk Investigational Site | Lodz | 90-153 | Poland |
| Novo Nordisk Investigational Site | Lubin | 59-301 | Poland |
| Novo Nordisk Investigational Site | Lublin | 20-081 | Poland |
| Novo Nordisk Investigational Site | Olsztyn | 10-561 | Poland |
| Novo Nordisk Investigational Site | Poznan | 60-821 | Poland |
| Novo Nordisk Investigational Site | Rzeszów | 35-301 | Poland |
| Novo Nordisk Investigational Site | Szczecin | 71-455 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 02-507 | Poland |
| Novo Nordisk Investigational Site | Zabrze | 41-800 | Poland |
| Novo Nordisk Investigational Site | Satu Mare | Satu Mare County | 440055 | Romania |
| Novo Nordisk Investigational Site | Botoșani | 710224 | Romania |
| Novo Nordisk Investigational Site | Bucharest | 020475 | Romania |
| Novo Nordisk Investigational Site | Galati | 800371 | Romania |
| Novo Nordisk Investigational Site | Targoviste | 130083 | Romania |
| Novo Nordisk Investigational Site | Kragujevac | 34000 | Serbia and Montenegro |
| Novo Nordisk Investigational Site | Nis | 18000 | Serbia and Montenegro |
| Novo Nordisk Investigational Site | Novi Sad | 21000 | Serbia and Montenegro |
| Novo Nordisk Investigational Site | Bloemfontein | Free State | 9301 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4091 | South Africa |
| Novo Nordisk Investigational Site | Brits | North West | 0250 | South Africa |
| Novo Nordisk Investigational Site | Alzira | 46600 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28040 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28041 | Spain |
| Novo Nordisk Investigational Site | Málaga | 29009 | Spain |
| Novo Nordisk Investigational Site | Gothenburg | 413 45 | Sweden |
| Novo Nordisk Investigational Site | Lund | 221 85 | Sweden |
| Novo Nordisk Investigational Site | Malmö | 205 02 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 182 88 | Sweden |
| Kalra S, Plata-Que T, Kumar D, Mumtaz M, Sondergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2. |
| Exposed to Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BIAsp 30 | Biphasic insulin aspart 30 + metformin + glimepiride |
| BG001 | Glargine | Insulin glargine + metformin + glimepiride |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Diabetes duration | Number of years since diagnosis of diabetes | Mean | Standard Deviation | years |
| ||||||||||||||
| HbA1c | Glycosylated Haemoglobin | Mean | Standard Deviation | percentage of total haemoglobin |
| ||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 | Glycosylated Haemoglobin A1c (HbA1c) | Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment. | Intention to Treat (Last Observation Carried Forward) population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement. | Posted | Least Squares Mean | Standard Deviation | percentage of total haemoglobin | After 26 weeks of treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 9-point Self-measured Plasma Glucose Profiles | Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points 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 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. 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. | Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement. | Posted | Mean | Standard Error | mmol/L | After 26 weeks of treatment |
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| Secondary | Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c) | The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin. | Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement. | Posted | Number | participants | After 26 weeks of treatment |
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| Secondary | Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat) | Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. | Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement. | Posted | Mean | Standard Error | scores on a scale | After 26 weeks of treatment |
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| Secondary | Number of Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced in each treatment arm. 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. | Posted | Number | events | Weeks 0-26 |
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| Secondary | Number of Subjects Reporting Treatment Emergent Adverse Events | Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration. | The safety analysis population consists of all subjects exposed to trial products. | Posted | Number | participants | Weeks 0-26 |
|
|
The adverse event were collected in a time span of 26 weeks.
The safety analysis population consists of all subjects exposed to trial 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 | Biphasic insulin aspart 30 + metformin + glimepiride | 13 | 231 | 56 | 231 | ||
| EG001 | Glargine | Insulin glargine + metformin + glimepiride | 10 | 238 | 63 | 238 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Biliary Colic | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Gastroenteritis Escherichia Coli | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Otitis Media Chronic | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Perianal Abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pneumonia Primary Atypical | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Vascular Graft Occlusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Diabetic Foot | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypoglycaemic Unconsciousness | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dupuytren's Contracture | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Guillain-Barre Syndrome | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypoglycaemic Coma | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Wart Excision | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
| |
| Arterial Thrombosis Limb | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypertensive Crisis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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Novo Nordisk maintains the right to be informed of any plans for publications 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| 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 |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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