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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005768-15 | EudraCT Number | ||
| U1111-1111-8545 | Other Identifier | WHO |
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This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp BID | Experimental |
| |
| BIAsp 30 BID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | 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) | Mean of SMPG after 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 | St Leonards | New South Wales | 2065 | Australia | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27553066 | Background | 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. | |
| 24812432 | Result | Fulcher GR, Christiansen JS, Bantwal G, Polaszewska-Muszynska M, Mersebach H, Andersen TH, Niskanen LK; BOOST: Intensify Premix I Investigators. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care. 2014 Aug;37(8):2084-90. doi: 10.2337/dc13-2908. Epub 2014 May 8. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Between screening and randomisation, eligible subjects were to continue their usual pre-trial oral anti-diabetic drug (OAD) of metformin, pioglitazone and DPP-4 inhibitor.
The trial was conducted at 50 sites in 10 countries: Australia (5 sites), Denmark (7 sites), Finland (5 sites), India (9 sites), Malaysia (3 sites), Poland (5 sites), Sweden (6 sites), Taiwan (3 sites), Thailand (3 sites), Turkey (4 sites).
In addition, 1 site in Thailand screened but did not randomise any subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp BID | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal. |
| FG001 | BIAsp 30 BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| biphasic insulin aspart 30 | Drug | Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone. |
|
| 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. |
| 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. | Week 0 to Week 26 + 7 days follow up |
| Wollongong |
| New South Wales |
| 2500 |
| Australia |
| Novo Nordisk Investigational Site | East Ringwood | Victoria | 3135 | Australia |
| Novo Nordisk Investigational Site | Melbourne | Victoria | 3004 | Australia |
| Novo Nordisk Investigational Site | Garran | 2605 | Australia |
| Novo Nordisk Investigational Site | Århus C | 8000 | Denmark |
| Novo Nordisk Investigational Site | Copenhagen | 2400 | Denmark |
| Novo Nordisk Investigational Site | Gentofte Municipality | 2820 | Denmark |
| Novo Nordisk Investigational Site | Hjørring | 9800 | Denmark |
| Novo Nordisk Investigational Site | Horsens | 8700 | Denmark |
| Novo Nordisk Investigational Site | Hvidovre | 2650 | Denmark |
| Novo Nordisk Investigational Site | Svendborg | 5700 | Denmark |
| Novo Nordisk Investigational Site | Kuopio | 70210 | Finland |
| Novo Nordisk Investigational Site | Lahti | 15110 | Finland |
| Novo Nordisk Investigational Site | Oulu | 90100 | Finland |
| Novo Nordisk Investigational Site | Pori | FI-28100 | Finland |
| Novo Nordisk Investigational Site | Ylitornio | FI-95600 | Finland |
| Novo Nordisk Investigational Site | Karnāl | Haryana | 132001 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560034 | India |
| Novo Nordisk Investigational Site | Trivandrum | Kerala | 695011 | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 4000021 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600 013 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600086 | India |
| Novo Nordisk Investigational Site | Kolkata | 700017 | India |
| Novo Nordisk Investigational Site | Mumbai | 400016 | India |
| Novo Nordisk Investigational Site | New Delhi | 110044 | 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 | Putrajaya | 62250 | Malaysia |
| Novo Nordisk Investigational Site | Bialystok | 15-445 | Poland |
| Novo Nordisk Investigational Site | Bydgoszcz | 85-822 | Poland |
| Novo Nordisk Investigational Site | Gniewkowo | 88-140 | Poland |
| Novo Nordisk Investigational Site | Płock | 09-400 | Poland |
| Novo Nordisk Investigational Site | Rawa Mazowiecka | 96-200 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 01-809 | Poland |
| Novo Nordisk Investigational Site | Falun | 791 82 | Sweden |
| Novo Nordisk Investigational Site | Karlstad | 651 85 | Sweden |
| Novo Nordisk Investigational Site | Lund | 221 85 | Sweden |
| Novo Nordisk Investigational Site | Lund | 222 22 | Sweden |
| Novo Nordisk Investigational Site | Malmö | 211 52 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 118 83 | Sweden |
| Novo Nordisk Investigational Site | Changhua | 500 | Taiwan |
| Novo Nordisk Investigational Site | Chiayi City | 600 | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 231 | Taiwan |
| Novo Nordisk Investigational Site | Bangkok | 10110 | Thailand |
| Novo Nordisk Investigational Site | Bangkok | 10330 | Thailand |
| Novo Nordisk Investigational Site | Bangkok | 10400 | Thailand |
| Novo Nordisk Investigational Site | Chiang Mai | 50200 | Thailand |
| Novo Nordisk Investigational Site | Istanbul | 34093 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34722 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34890 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Kocaeli | 41380 | Turkey (Türkiye) |
| 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. |
| 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. |
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp BID | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal. |
| BG001 | BIAsp 30 BID | Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
| |||||||||||||||
| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mmol/L |
|
| 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) | 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). One subject was randomised in error, hence removed from the FAS. | 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) | Mean of SMPG after 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). One subject was randomised in error, hence removed from the FAS. For 24 subjects all 9-point SMPG values were missing. | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
|
| |||||||||||||||||||||||||||||
| 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. | 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 |
|
| ||||||||||||||||||||||||||||||
| 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring 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 |
|
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 subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal. | 19 | 224 | 60 | 224 | ||
| EG001 | BIAsp 30 BID | Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal. | 36 | 222 | 52 | 222 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac asthma | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Incorrect dose administered | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Snake bite | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Cervicobrachial syndrome | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Adenomyosis | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
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| Breast mass | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
Not provided
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| Male |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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