| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011271-78 | EudraCT Number | ||
| U1111-1111-7178 | Other Identifier | WHO | |
| 2009-015839-33 | EudraCT Number | ||
| U1111-1114-9237 | Other Identifier | WHO |
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This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).
The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp OD | Experimental |
| |
| IGlar OD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment | Change from baseline in HbA1c after 26 weeks of treatment. | Week 0, Week 26 |
| Extension Trial (Primary Endpoint): 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/L. | Week 0 to Week 53 + 7 days follow up |
| Extension Trial (Primary Endpoint): 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 occurring between 00:01 and 05:59 a.m. | Week 0 to Week 53 + 7 days follow up |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect |
| Measure | Description | Time Frame |
|---|---|---|
| Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment | Change from baseline in HbA1c after 52 weeks of treatment. | Week 0, Week 53 |
| Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 |
Not provided
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 | Birmingham | Alabama | 35233 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27760129 | Result | Kumar A, Franek E, Wise J, Niemeyer M, Mersebach H, Simo R. Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100) for 52 Weeks in Insulin-Naive Patients with Type 2 Diabetes: A Randomized Controlled Trial. PLoS One. 2016 Oct 19;11(10):e0163350. doi: 10.1371/journal.pone.0163350. eCollection 2016. | |
| 35044568 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
The total duration of treatment was up to 52 weeks (26 weeks [main trial: NN5401-3590, NCT01045707] + 26 weeks [extension trial: NN5401-3726]), separated by 1 week of wash-out period; during which subjects were treated with Neutral Protamine Hagedorn (NPH) insulin twice daily (BID) in combination with subject's pre-trial treatment of metformin.
The trial was conducted at 88 sites in 8 countries: Austria (4), India (7), South Korea (5), Poland (6), Russia (10), Spain (11), Turkey (5), and United States of America (40). Some sites did not enroll subjects in the extension period.
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main: Week 0 to 26 (NN5401-3590) |
|
Not provided
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| insulin glargine | Drug | Injected s.c. (under the skin) once daily. Dose was individually adjusted. |
|
| Week 0 to Week 53 + 7 days follow up |
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 |
| Vestavia Hills |
| Alabama |
| 35209 |
| United States |
| Novo Nordisk Investigational Site | Concord | California | 94520-1926 | United States |
| Novo Nordisk Investigational Site | Greenbrae | California | 94904 | United States |
| Novo Nordisk Investigational Site | Los Angeles | California | 90057 | United States |
| Novo Nordisk Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33135 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33136 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33169 | United States |
| Novo Nordisk Investigational Site | North Miami | Florida | 33161 | United States |
| Novo Nordisk Investigational Site | Pembroke Pines | Florida | 33027 | United States |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96813 | United States |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96814 | United States |
| Novo Nordisk Investigational Site | Idaho Falls | Idaho | 83404-7596 | United States |
| Novo Nordisk Investigational Site | Council Bluffs | Iowa | 51501 | United States |
| Novo Nordisk Investigational Site | Metairie | Louisiana | 70006-2930 | United States |
| Novo Nordisk Investigational Site | New Orleans | Louisiana | 70119 | United States |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48235 | United States |
| Novo Nordisk Investigational Site | Troy | Michigan | 48085-5524 | United States |
| Novo Nordisk Investigational Site | Saint Charles | Missouri | 63303 | United States |
| Novo Nordisk Investigational Site | Springfield | Missouri | 65807 | United States |
| Novo Nordisk Investigational Site | Brooklyn | New York | 11203 | United States |
| Novo Nordisk Investigational Site | Smithtown | New York | 11787 | United States |
| Novo Nordisk Investigational Site | Greensboro | North Carolina | 27408 | United States |
| Novo Nordisk Investigational Site | Greenville | North Carolina | 27834 | United States |
| Novo Nordisk Investigational Site | Morehead City | North Carolina | 28557 | United States |
| Novo Nordisk Investigational Site | Wilson | North Carolina | 27893 | United States |
| Novo Nordisk Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97220 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239 | United States |
| Novo Nordisk Investigational Site | Greer | South Carolina | 29651 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Novo Nordisk Investigational Site | Memphis | Tennessee | 38119 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75235 | United States |
| Novo Nordisk Investigational Site | Lubbock | Texas | 79423 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78240 | United States |
| Novo Nordisk Investigational Site | Tomball | Texas | 77375 | United States |
| Novo Nordisk Investigational Site | St. George | Utah | 84790 | United States |
| Novo Nordisk Investigational Site | Newport News | Virginia | 23606 | United States |
| Novo Nordisk Investigational Site | Olympia | Washington | 98502 | United States |
| Novo Nordisk Investigational Site | Ebreichsdorf | 2483 | Austria |
| Novo Nordisk Investigational Site | Feldbach | 8330 | Austria |
| Novo Nordisk Investigational Site | Innsbruck | 6020 | Austria |
| Novo Nordisk Investigational Site | Salzburg | 5010 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1030 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1060 | Austria |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400053 | India |
| Novo Nordisk Investigational Site | Jaipur | Rajasthan | 302006 | India |
| Novo Nordisk Investigational Site | Trichy | Tamil Nadu | 620018 | India |
| Novo Nordisk Investigational Site | Bangalore | 560038 | India |
| Novo Nordisk Investigational Site | Kerala | 682026 | India |
| Novo Nordisk Investigational Site | Patna | 800020 | India |
| Novo Nordisk Investigational Site | Krakow | 31-261 | Poland |
| Novo Nordisk Investigational Site | Lodz | 90-003 | Poland |
| Novo Nordisk Investigational Site | Lodz | 93-338 | Poland |
| Novo Nordisk Investigational Site | Lublin | 20-044 | Poland |
| Novo Nordisk Investigational Site | Pruszków | 05-800 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 02-507 | Poland |
| Novo Nordisk Investigational Site | Bayamón | 00961 | Puerto Rico |
| Novo Nordisk Investigational Site | Arkhangelsk | 163045 | Russia |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Nizhny Novgorod | 603126 | Russia |
| Novo Nordisk Investigational Site | Orenburg | 460040 | Russia |
| Novo Nordisk Investigational Site | Samara | 443067 | Russia |
| Novo Nordisk Investigational Site | Saratov | 410053 | Russia |
| Novo Nordisk Investigational Site | Saratov | 410710 | Russia |
| Novo Nordisk Investigational Site | Smolensk | 214019 | Russia |
| Novo Nordisk Investigational Site | Stavropol | 355017 | Russia |
| Novo Nordisk Investigational Site | Yaroslavl | 150003 | Russia |
| Novo Nordisk Investigational Site | Pucheon | 424-017 | South Korea |
| Novo Nordisk Investigational Site | Pusan | 602-739 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 08308 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 137-701 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 158-710 | South Korea |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Málaga | 29006 | Spain |
| Novo Nordisk Investigational Site | Mérida | 06800 | Spain |
| Novo Nordisk Investigational Site | Palma de Mallorca | 07198 | Spain |
| Novo Nordisk Investigational Site | Partida de Bacarot | 03114 | Spain |
| Novo Nordisk Investigational Site | Pozuelo de Alarcón | 28223 | Spain |
| Novo Nordisk Investigational Site | San Sebastián de los Reyes | 28700 | Spain |
| Novo Nordisk Investigational Site | Santiago de Compostela | 15706 | Spain |
| Novo Nordisk Investigational Site | Seville | 41009 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46014 | Spain |
| Novo Nordisk Investigational Site | Valladolid | 47005 | Spain |
| Novo Nordisk Investigational Site | Antalya | 07058 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34096 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34390 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34400 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34760 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | Turkey (Türkiye) |
| 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. |
| IGlar OD |
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period). |
| Exposed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension: Week 27 to 52 (NN5401-3726) |
|
|
Baseline characteristics for all the randomised subjects (the full analysis set [FAS]) were collected at the beginning of main trial. One subject was excluded from FAS because the subject was randomised in error and was not dosed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period. |
| BG001 | IGlar OD | Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) 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). One subject was excluded from FAS because the subject was randomised in error and was not dosed. | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, Week 26 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment | Change from baseline in HbA1c after 52 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 excluded from FAS because the subject was randomised in error and was not dosed. | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, Week 53 |
|
| |||||||||||||||||||||||||||||
| Secondary | Main Trial (Secondary Endpoint): 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). One subject was excluded from FAS because the subject was randomised in error and was not dosed. For 24 subjects all 9-point SMPG values were missing. | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
| ||||||||||||||||||||||||||||||
| Primary | Extension Trial (Primary Endpoint): 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/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 53 + 7 days follow up |
| |||||||||||||||||||||||||||||||
| Primary | Extension Trial (Primary Endpoint): 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 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 53 + 7 days follow up |
| |||||||||||||||||||||||||||||||
| Primary | Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | Events/100 years of patient exposure | Week 0 to Week 53 + 7 days follow up |
|
Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
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 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period. | 30 | 265 | 88 | 265 | ||
| EG001 | IGlar OD | Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period). | 15 | 261 | 79 | 261 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Polymyalgia Rheumatica | Musculoskeletal and connective tissue disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V 13.1 & 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V 13.1 & 14.0 | 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Withdrawal criteria |
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| Unclassified |
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| Male |
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| Participants |
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