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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1118-0124 | Other Identifier | WHO | |
| JapicCTI-111385 | Registry Identifier | JAPIC |
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This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.
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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 | Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Observed change from baseline in HbA1c after 26 weeks of treatment | Week 0, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal | Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal | Week 26 |
| Rate of Treatment Emergent Adverse Events (AEs) |
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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 | Asahikawa-shi, Hokkaido | 070 0002 | Japan | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23557077 | Result | Onishi Y, Ono Y, Rabol R, Endahl L, Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013 Sep;15(9):826-32. doi: 10.1111/dom.12097. Epub 2013 Apr 5. | |
| 35044568 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects continued on not more than 2 oral antidiabetic drugs (excluding sulphonylureas/dipeptyl peptidase-4 [DPP-4] inhibitors/glinides) at the pre-randomisation dose level and dosing frequency.
The trial was conducted at 48 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin glargine | Drug | Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs. |
|
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with 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 hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. |
| Week 0 to Week 26 + 7 days follow up |
| Rate of Confirmed Hypoglycaemic Episodes | Observed 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 | Observed 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 |
| Change in Body Weight | Observed change from baseline in body weight after 26 weeks of treatment | Week 0, Week 26 |
| Chigasaki-shi, Kanagawa |
| 253 0052 |
| Japan |
| Novo Nordisk Investigational Site | Chuo-ku, Tokyo | 103 0002 | Japan |
| Novo Nordisk Investigational Site | Chuo-ku, Tokyo | 103 0027 | Japan |
| Novo Nordisk Investigational Site | Ebina-shi | 243 0432 | Japan |
| Novo Nordisk Investigational Site | Fukuoka-shi, Fukuoka | 815 8555 | Japan |
| Novo Nordisk Investigational Site | Iruma-shi, Saitama | 358 0003 | Japan |
| Novo Nordisk Investigational Site | Izumisano | 598 0048 | Japan |
| Novo Nordisk Investigational Site | Kamakura-shi | 247 0056 | Japan |
| Novo Nordisk Investigational Site | Kanagawa-shi, Yokohama | 221 0802 | Japan |
| Novo Nordisk Investigational Site | Kashiwa-shi, Chiba | 277 0825 | Japan |
| Novo Nordisk Investigational Site | Kashiwara-shi, Osaka | 582 0005 | Japan |
| Novo Nordisk Investigational Site | Katsushika-ku, Tokyo | 125 0054 | Japan |
| Novo Nordisk Investigational Site | Kawagoe-shi, Saitama | 350 0851 | Japan |
| Novo Nordisk Investigational Site | Kitakyushu-shi, Fukuoka | 800 0252 | Japan |
| Novo Nordisk Investigational Site | Koriyama-shi, Fukushima | 963 8851 | Japan |
| Novo Nordisk Investigational Site | Kumamoto-shi, Kumamoto | 861 8045 | Japan |
| Novo Nordisk Investigational Site | Kumamoto-shi,Kumamoto | 862 0976 | Japan |
| Novo Nordisk Investigational Site | Kurume-shi, Fukuoka | 830 8577 | Japan |
| Novo Nordisk Investigational Site | Kurume-shi, Fukuoka | 839 0863 | Japan |
| Novo Nordisk Investigational Site | Kyoto-shi, Kyoto | 615 8125 | Japan |
| Novo Nordisk Investigational Site | Matsumoto-shi, Nagano | 399 0006 | Japan |
| Novo Nordisk Investigational Site | Miyazaki | 880 0034 | Japan |
| Novo Nordisk Investigational Site | Naha | 900 0032 | Japan |
| Novo Nordisk Investigational Site | Naka-shi, Ibaraki | 311 0113 | Japan |
| Novo Nordisk Investigational Site | Nishinomiya-shi, Hygo | 662 0971 | Japan |
| Novo Nordisk Investigational Site | Obihiro-shi, Hokkaido | 080 0016 | Japan |
| Novo Nordisk Investigational Site | Obihiro-shi, Hokkaido | 080 0848 | Japan |
| Novo Nordisk Investigational Site | Ogawa | 355 0321 | Japan |
| Novo Nordisk Investigational Site | Okawa-shi, Fukuoka | 831 0016 | Japan |
| Novo Nordisk Investigational Site | Ota-ku, Tokyo | 144 0035 | Japan |
| Novo Nordisk Investigational Site | Oyama-shi, Tochigi | 323 0022 | Japan |
| Novo Nordisk Investigational Site | Ōita | 870 0039 | Japan |
| Novo Nordisk Investigational Site | Sapporo, Hokkaido | 060 0033 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 060 0062 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 060-0001 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 062 0007 | Japan |
| Novo Nordisk Investigational Site | Sappro-shi, Hokkaido | 060 8648 | Japan |
| Novo Nordisk Investigational Site | Sasebo-shi, Nagasaki | 857 1165 | Japan |
| Novo Nordisk Investigational Site | Sendai | 980 0021 | Japan |
| Novo Nordisk Investigational Site | Shimotsuke-shi, Tochigi | 329 0433 | Japan |
| Novo Nordisk Investigational Site | Shizuoka | 424 0853 | Japan |
| Novo Nordisk Investigational Site | Tagajō-shi | 985 0852 | Japan |
| Novo Nordisk Investigational Site | Tagawa-shi, Fukuoka | 825 8567 | Japan |
| Novo Nordisk Investigational Site | Takatsuki-shi, Osaka | 569 1096 | Japan |
| Novo Nordisk Investigational Site | Tamana-shi, Kumamoto | 865 0064 | Japan |
| Novo Nordisk Investigational Site | Tokyo | 167 0043 | Japan |
| Novo Nordisk Investigational Site | Tsuchiura-shi, Ibaraki | 300 0832 | Japan |
| Novo Nordisk Investigational Site | Urasoe-shi, | 901 2104 | Japan |
| Novo Nordisk Investigational Site | Yokohama-shi, Kanagawa | 227 0054 | Japan |
| 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. |
| FG001 |
| IGlar OD |
Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted. |
| BG001 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
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| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mmol/L |
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| Body weight | Mean | Standard Deviation | kg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycosylated Haemoglobin (HbA1c) | Observed change from baseline in HbA1c after 26 weeks of treatment | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, Week 26 |
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| Secondary | Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal | Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
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| Secondary | 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 subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with 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 hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. | Safety analysis set includes 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 26 + 7 days follow up |
| |||||||||||||||||||||||||||||||
| Secondary | Rate of Confirmed Hypoglycaemic Episodes | Observed 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. | Safety analysis set includes 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 | Observed 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. | Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
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| Secondary | Change in Body Weight | Observed change from baseline in body weight after 26 weeks of treatment | Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | kg | Week 0, Week 26 |
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The adverse events were collected in a time frame of 26 weeks + 7 days follow up.
Safety analysis set includes 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 subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted. | 5 | 147 | 37 | 147 | ||
| EG001 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted. | 3 | 149 | 47 | 149 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pulmonary tuberculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Osteitis condensans | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinopathy | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | 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 |
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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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