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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1111-7226 | Other Identifier | WHO | |
| 2008-005767-34 | EudraCT Number |
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This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp OD | Experimental |
| |
| IGlar OD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted. |
|
| 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 | Fresno | California | 93720 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26582052 | Result | Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18. | |
| 27027878 | Result | Kumar S, Jang HC, Demirag NG, Skjoth TV, Endahl L, Bode B. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabet Med. 2017 Feb;34(2):180-188. doi: 10.1111/dme.13125. Epub 2016 Jul 28. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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The trial was conducted at 61 sites in 9 countries: Croatia (2 sites), France (4), India (8), Poland (4), South Africa (3), Republic of Korea (6), Sweden (5), Turkey (5) and United States of America (24).
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor. |
| FG001 | IGlar OD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin glargine | Drug | Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted. |
|
| Waterbury |
| Connecticut |
| 06708 |
| United States |
| Novo Nordisk Investigational Site | Boynton Beach | Florida | 33472 | United States |
| Novo Nordisk Investigational Site | Clearwater | Florida | 33765 | United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32216 | United States |
| Novo Nordisk Investigational Site | Kissimmee | Florida | 34741 | United States |
| Novo Nordisk Investigational Site | New Port Richey | Florida | 34652 | United States |
| Novo Nordisk Investigational Site | Orlando | Florida | 32804 | United States |
| Novo Nordisk Investigational Site | Pembroke Pines | Florida | 33027 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33603 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30318 | United States |
| Novo Nordisk Investigational Site | Des Moines | Iowa | 50314-2610 | United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21204 | United States |
| Novo Nordisk Investigational Site | Hyattsville | Maryland | 20782 | United States |
| Novo Nordisk Investigational Site | Waltham | Massachusetts | 02453 | United States |
| Novo Nordisk Investigational Site | Southfield | Michigan | 48034 | United States |
| Novo Nordisk Investigational Site | Southfield | Michigan | 48075 | United States |
| Novo Nordisk Investigational Site | Minneapolis | Minnesota | 55416 | United States |
| Novo Nordisk Investigational Site | Nashua | New Hampshire | 03063 | United States |
| Novo Nordisk Investigational Site | Albany | New York | 12206 | United States |
| Novo Nordisk Investigational Site | Statesville | North Carolina | 28625 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75231 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75235 | United States |
| Novo Nordisk Investigational Site | Round Rock | Texas | 78681 | United States |
| Novo Nordisk Investigational Site | Osijek | 31 000 | Croatia |
| Novo Nordisk Investigational Site | Rijeka | 51000 | Croatia |
| Novo Nordisk Investigational Site | Antibes | 06600 | France |
| Novo Nordisk Investigational Site | Besançon | 25030 | France |
| Novo Nordisk Investigational Site | Dax | 40107 | France |
| Novo Nordisk Investigational Site | Paris | 75877 | France |
| Novo Nordisk Investigational Site | Perpignan | 66046 | France |
| Novo Nordisk Investigational Site | Saint-Herblain | 44800 | France |
| Novo Nordisk Investigational Site | Sète | 34200 | France |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | 380 015 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560092 | India |
| Novo Nordisk Investigational Site | Belagavi | Karnataka | 590001 | India |
| Novo Nordisk Investigational Site | Mangalore | Karnataka | 575001 | India |
| Novo Nordisk Investigational Site | Thiruvanathapuram | Kerala | 695010 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411 037 | India |
| Novo Nordisk Investigational Site | Bhubaneswar | Odisha | 751019 | India |
| Novo Nordisk Investigational Site | Kanpur | 208005 | India |
| Novo Nordisk Investigational Site | Gdansk | 80-858 | Poland |
| Novo Nordisk Investigational Site | Tychy | 43-100 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 00-911 | Poland |
| Novo Nordisk Investigational Site | Wroclaw | 50-127 | Poland |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 1818 | South Africa |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 1827 | South Africa |
| Novo Nordisk Investigational Site | Benoni | 1500 | South Africa |
| Novo Nordisk Investigational Site | Busan | 602-715 | South Korea |
| Novo Nordisk Investigational Site | Daegu | 700-721 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 03080 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 134-727 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 135-239 | South Korea |
| Novo Nordisk Investigational Site | Sungnam | 463-707 | South Korea |
| Novo Nordisk Investigational Site | Ängelholm | 262 91 | Sweden |
| Novo Nordisk Investigational Site | Dalby | 240 10 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 417 17 | Sweden |
| Novo Nordisk Investigational Site | Härnösand | 871 82 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 171 76 | Sweden |
| Novo Nordisk Investigational Site | Istanbul | 34098 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34400 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34662 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34718 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Kahramanmaraş | 46000 | Turkey (Türkiye) |
| 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. |
Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor. |
| BG001 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor. |
| 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 was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS. | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, Week 26 |
|
|
| ||||||||||||||||||||||||||||
| 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 was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS. For 23 subjects all 9-point SMPG values were missing. | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
|
|
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 OD | Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor. | 10 | 230 | 51 | 230 | ||
| EG001 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor. | 8 | 233 | 62 | 233 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial fibrillation | 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 |
| |
| Cataract | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | 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 |
|
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 |
| D000069036 | Insulin Glargine |
| 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 |
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| Male |
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