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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003152-37 | EudraCT Number | ||
| U1111-1132-2674 | Other Identifier | WHO |
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This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp BID + IAsp OD | Experimental |
| |
| IDeg OD + IAsp TID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Change from baseline in HbA1c after 26 weeks of treatment | Week 0, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product. | During 26 weeks of treatment |
| Number of Treatment Emergent Hypoglycaemic Episodes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
| 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 | Goodyear | Arizona | 85395 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27853981 | Result | Bebakar WM, Chaykin L, Herslov ML, Rasmussen S. Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal-Bolus): Exploratory Randomized Trial in Type 2 Diabetes. Diabetes Ther. 2017 Feb;8(1):197-205. doi: 10.1007/s13300-016-0213-8. Epub 2016 Nov 16. | |
| 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Subjects who did not reach the HbA1c target < 7.0% on IDegAsp BID after 26 weeks of treatment in trial NN5401-3941 were enrolled in this trial.
The trial was conducted at 20 sites in 4 countries as follows: Germany: 1 site; Malaysia: 2 sites; Turkey: 1 site; United States: 16 sites. The subjects in this trial were to continue from trial NN5401-3941 (NCT01680341).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp BID + IAsp OD | Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| insulin degludec | Drug | For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged). |
|
| insulin aspart | Drug | For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted. |
|
| insulin aspart | Drug | For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted. |
|
Confirmed hypoglycaemic episodes were defined as episodes that are either:
|
| During 26 weeks of treatment |
| Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes | Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL). | During 26 weeks of treatment |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally. | Week 0, week 26 |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Novo Nordisk Investigational Site | Anaheim | California | 92801 | United States |
| Novo Nordisk Investigational Site | Greenbrae | California | 94904 | United States |
| Novo Nordisk Investigational Site | San Diego | California | 92111 | United States |
| Novo Nordisk Investigational Site | Spring Valley | California | 91978 | United States |
| Novo Nordisk Investigational Site | Bradenton | Florida | 34201 | United States |
| Novo Nordisk Investigational Site | Kissimmee | Florida | 34741 | United States |
| Novo Nordisk Investigational Site | Plantation | Florida | 33324 | United States |
| Novo Nordisk Investigational Site | Avon | Illinois | 46123 | United States |
| Novo Nordisk Investigational Site | Crystal Lake | Illinois | 60012 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46254 | United States |
| Novo Nordisk Investigational Site | Slidell | Louisiana | 70461-4231 | United States |
| Novo Nordisk Investigational Site | Waltham | Massachusetts | 02453 | United States |
| Novo Nordisk Investigational Site | Buckley | Michigan | 49620 | United States |
| Novo Nordisk Investigational Site | Nashua | New Hampshire | 03063 | United States |
| Novo Nordisk Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Novo Nordisk Investigational Site | Toms River | New Jersey | 08755-8050 | United States |
| Novo Nordisk Investigational Site | Albany | New York | 12206 | United States |
| Novo Nordisk Investigational Site | Myrtle Beach | South Carolina | 29572 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75251 | United States |
| Novo Nordisk Investigational Site | Fort Worth | Texas | 76132 | United States |
| Novo Nordisk Investigational Site | Olympia | Washington | 98502 | United States |
| Novo Nordisk Investigational Site | Tacoma | Washington | 98405 | United States |
| Novo Nordisk Investigational Site | Kenosha | Wisconsin | 53142 | United States |
| Novo Nordisk Investigational Site | Algiers | 16000 | Algeria |
| Novo Nordisk Investigational Site | Oran | 31000 | Algeria |
| Novo Nordisk Investigational Site | Tizi Ouzou | 16015 | Algeria |
| Novo Nordisk Investigational Site | Erdmannhausen | 71729 | Germany |
| Novo Nordisk Investigational Site | Münster | 48145 | Germany |
| Novo Nordisk Investigational Site | Neuwied | 56564 | Germany |
| Novo Nordisk Investigational Site | Rehlingen-Siersburg | 66780 | Germany |
| Novo Nordisk Investigational Site | Saint Ingbert | 66386 | Germany |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Kuala Selangor | 46150 | Malaysia |
| Novo Nordisk Investigational Site | Denizli | 20070 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Gaziantep | 27070 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Hatay | 31040 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34752 | Turkey (Türkiye) |
| FG001 | IDeg OD + IAsp TID | Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomised subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp BID + IAsp OD | Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion. |
| BG001 | IDeg OD + IAsp TID | Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion. |
| 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 From Baseline in HbA1c (Glycosylated Haemoglobin) | Change from baseline in HbA1c after 26 weeks of treatment | The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | percentage of glycosylated haemoglobin | Week 0, week 26 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of Treatment Emergent Adverse Events (TEAEs) | A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product. | Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product. | Posted | Number | number of events | During 26 weeks of treatment |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes | Confirmed hypoglycaemic episodes were defined as episodes that are either:
| The SAS included all subjects receiving at least one dose of the investigational product. | Posted | Number | episodes | During 26 weeks of treatment |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes | Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL). | The SAS included all subjects receiving at least one dose of the investigational product. | Posted | Number | episodes | During 26 weeks of treatment |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally. | The FAS included all randomised subjects and missing data was imputed using LOCF. One subject in each arm did not have FPG values from week 0. | Posted | Mean | Standard Deviation | mmol/L | Week 0, week 26 |
|
Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational 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 | IDeg OD + IAsp TID | Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion. | 2 | 20 | 16 | 20 | ||
| EG001 | IDegAsp BID + IAsp OD | Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion. | 2 | 20 | 15 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA version 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Retinal aneurysm | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
| |
| Wrong drug administered | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 16.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
Due to the highly selected trial population randomised in this trial (N=40), the results should be interpreted with caution.
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 |
| C571886 | insulin degludec |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-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 |
Not provided
Not provided
| Male |
|
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|
| IDeg OD + IAsp TID |
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion. |
|
|
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion. |
|
|
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|