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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1111-7210 | Other Identifier | WHO | |
| 101040 | Registry Identifier | JAPIC |
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This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp BID | Experimental |
| |
| BIAsp 30 BID | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Injected subcutaneously twice daily. Dose was individually adjusted. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment | Change from baseline in HbA1c after 26 weeks of treatment. | Week 0, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 | Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. | Week 26 |
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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 | Shatin, New Territories | Hong Kong | ||||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27553066 | Result | Evans M, Gundgaard J, Hansen BB. Cost-Effectiveness of Insulin Degludec/Insulin Aspart Versus Biphasic Insulin Aspart in Patients with Type 2 Diabetes from a Danish Health-Care Perspective. Diabetes Ther. 2016 Dec;7(4):809-823. doi: 10.1007/s13300-016-0195-6. Epub 2016 Aug 23. | |
| 26612062 | Result | Christiansen JS, Niskanen L, Rasmussen S, Johansen T, Fulcher G. Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. J Diabetes. 2016 Sep;8(5):720-8. doi: 10.1111/1753-0407.12355. Epub 2016 Mar 6. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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The trial was conducted at 45 sites in 5 countries: Japan (16 sites), South Korea (16 sites), Hong Kong (1 site), Malaysia (8 sites) and Taiwan (4 sites).
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp BID | Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin. |
| FG001 | BIAsp 30 BID | Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| biphasic insulin aspart 30 | Drug | Injected subcutaneously twice daily. Dose was individually adjusted. |
|
| Rate of Confirmed Hypoglycaemic Episodes |
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol. |
| Week 0 to Week 26 + 7 days follow up |
| Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. | Week 0 to Week 26 + 7 days follow up |
| Change in Body Weight | Change from baseline in body weight after 26 weeks of treatment. | Week 0, Week 26 |
| Chūōku |
| 104 0061 |
| Japan |
| Novo Nordisk Investigational Site | Imizu-shi | 939 0363 | Japan |
| Novo Nordisk Investigational Site | Kamakura-shi | 247 0056 | Japan |
| Novo Nordisk Investigational Site | Kashiwara-shi, Osaka | 582-0005 | Japan |
| Novo Nordisk Investigational Site | Koriyama-shi, Fukushima | 963-8851 | Japan |
| Novo Nordisk Investigational Site | Kumamoto-shi, Kumamoto | 862-0976 | Japan |
| Novo Nordisk Investigational Site | Matsumoto-shi | 390 8510 | Japan |
| Novo Nordisk Investigational Site | Naha | 900 0032 | Japan |
| Novo Nordisk Investigational Site | Naka-shi, Ibaraki | 311-0113 | Japan |
| Novo Nordisk Investigational Site | Oyama-shi, Tochigi | 323-0022 | Japan |
| Novo Nordisk Investigational Site | Ōita | 870 0039 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 060-0062 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 062-0007 | Japan |
| Novo Nordisk Investigational Site | Takatsuki-shi, Osaka | 569-1096 | Japan |
| Novo Nordisk Investigational Site | Urasoe-shi, | 901 2104 | Japan |
| Novo Nordisk Investigational Site | Yokohama-shi, Kanagawa | 235-0045 | Japan |
| Novo Nordisk Investigational Site | Cheras | 56000 | Malaysia |
| Novo Nordisk Investigational Site | Georgetown, Penang | 10450 | Malaysia |
| Novo Nordisk Investigational Site | Johor Bahru | 80100 | Malaysia |
| Novo Nordisk Investigational Site | Klang, Selangor | 41200 | Malaysia |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Kota Kinabalu | 88586 | Malaysia |
| Novo Nordisk Investigational Site | Putrajaya | 62250 | Malaysia |
| Novo Nordisk Investigational Site | Seremban | 70300 | Malaysia |
| Novo Nordisk Investigational Site | Ansan | 152-703 | South Korea |
| Novo Nordisk Investigational Site | Daegu | 705-717 | South Korea |
| Novo Nordisk Investigational Site | Daegu | 705-718 | South Korea |
| Novo Nordisk Investigational Site | Guri-si | 471-101 | South Korea |
| Novo Nordisk Investigational Site | Gyeonggi-do | 480-717 | South Korea |
| Novo Nordisk Investigational Site | Incheon | 400-103 | South Korea |
| Novo Nordisk Investigational Site | Incheon | 405-760 | South Korea |
| Novo Nordisk Investigational Site | Jeollanamdo | 501-717 | South Korea |
| Novo Nordisk Investigational Site | Pusan | 602-739 | South Korea |
| Novo Nordisk Investigational Site | Seongnam-si | 463-707 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 02447 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 02841 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 120-752 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 134-701 | South Korea |
| Novo Nordisk Investigational Site | Suwon | 16499 | South Korea |
| Novo Nordisk Investigational Site | Wŏnju | 220-701 | South Korea |
| Novo Nordisk Investigational Site | Kaohsiung City | 833 | Taiwan |
| Novo Nordisk Investigational Site | Taichung | 404 | Taiwan |
| Novo Nordisk Investigational Site | Tainan | 710 | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 100 | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 112 | Taiwan |
| 27059529 | Result | Taneda S, Hyllested-Winge J, Gall MA, Kaneko S, Hirao K. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. J Diabetes. 2017 Mar;9(3):243-247. doi: 10.1111/1753-0407.12407. Epub 2016 Jul 7. |
| 29451706 | Result | Haluzik M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25. |
| 30474818 | Result | Fulcher G, Mehta R, Fita EG, Ekelund M, Bain SC. Efficacy and Safety of IDegAsp Versus BIAsp 30, Both Twice Daily, in Elderly Patients with Type 2 Diabetes: Post Hoc Analysis of Two Phase 3 Randomized Controlled BOOST Trials. Diabetes Ther. 2019 Feb;10(1):107-118. doi: 10.1007/s13300-018-0531-0. Epub 2018 Nov 24. |
| 35044568 | Derived | Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19. |
| 25498130 | Derived | Kaneko S, Chow F, Choi DS, Taneda S, Hirao K, Park Y, Andersen TH, Gall MA, Christiansen JS; BOOST: Intensify All Trial Investigators. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week, randomised, treat-to-target trial. Diabetes Res Clin Pract. 2015 Jan;107(1):139-47. doi: 10.1016/j.diabres.2014.09.026. Epub 2014 Oct 14. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline characterises are presented for full analysis set (FAS), which included all randomized subjects. In exceptional cases subjects from the FAS were eliminated; 2 subjects in the IDegAsp group were excluded from the FAS because the subjects were randomized in error in spite of being screening failures.
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp BID | Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin. |
| BG001 | BIAsp 30 BID | Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin. |
| 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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| Sex: Female, Male | Count of Participants | Participants |
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| Glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
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| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mmol/L |
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| Body weight at randomisation | 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) After 26 Weeks of Treatment | Change from baseline in HbA1c after 26 weeks of treatment. | The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, Week 26 |
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| Secondary | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 | Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. | The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 24 subjects all 9-point SMPG values were missing. | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
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| Secondary | Rate of Confirmed Hypoglycaemic Episodes | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
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| Secondary | Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
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| Secondary | Change in Body Weight | Change from baseline in body weight after 26 weeks of treatment. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Mean | Standard Deviation | kg | Week 0, Week 26 |
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The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
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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 | IDegAsp BID | Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin. | 23 | 279 | 84 | 279 | ||
| EG001 | BIAsp 30 BID | Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin. | 12 | 141 | 39 | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Diabetic foot | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
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| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
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| Carotid artery occlusion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinopathy | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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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 |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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| Male |
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| Participants |
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