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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-0558 | Other Identifier | WHO |
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This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp Simple | Experimental |
| |
| IDegAsp Step wise | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted. |
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| 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 |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | Change from baseline in FPG after 26 weeks of treatment. | Week 0, week 26 |
| 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. |
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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 | Concord | California | 94520-1926 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26773557 | Result | Park SW, Bebakar WM, Hernandez PG, Macura S, Herslov ML, de la Rosa R. Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST(R) : SIMPLE USE). Diabet Med. 2017 Feb;34(2):174-179. doi: 10.1111/dme.13069. Epub 2016 Mar 6. | |
| 35044568 | Derived |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects continued their metformin monotherapy or metformin in any combination with 1 or 2 additional oral antidiabetic drugs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV inhibitors, α-glucosidase inhibitors, thiazolidinediones, all with unchanged dosing for at least 12 weeks prior to randomisation.
This trial was conducted at 38 sites in 6 countries: Malaysia, Mexico, South Korea, Thailand, Turkey and the United States (U.S.).
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp Simple | Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 0 to Week 26 + 7 days follow up |
| Rate of Confirmed Hypoglycaemic Episodes | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. | Week 0 to Week 26 + 7 days follow up |
| Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Rate of nocturnal 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 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Novo Nordisk Investigational Site | Montclair | California | 91763 | United States |
| Novo Nordisk Investigational Site | Palm Springs | California | 92262 | United States |
| Novo Nordisk Investigational Site | Spring Valley | California | 91978 | United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32209-6511 | United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32258 | United States |
| Novo Nordisk Investigational Site | Pembroke Pines | Florida | 33027 | United States |
| Novo Nordisk Investigational Site | Crestview Hills | Kentucky | 41017-3464 | United States |
| Novo Nordisk Investigational Site | Madisonville | Kentucky | 42431 | United States |
| Novo Nordisk Investigational Site | Paducah | Kentucky | 42003 | United States |
| Novo Nordisk Investigational Site | Hyattsville | Maryland | 20782 | United States |
| Novo Nordisk Investigational Site | North East | Maryland | 21901 | 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 | Eagan | Minnesota | 55123 | United States |
| Novo Nordisk Investigational Site | Smithtown | New York | 11787 | United States |
| Novo Nordisk Investigational Site | Asheboro | North Carolina | 27203 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75246 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77070 | United States |
| Novo Nordisk Investigational Site | Lubbock | Texas | 79423 | United States |
| Novo Nordisk Investigational Site | Sugar Land | Texas | 77478 | United States |
| Novo Nordisk Investigational Site | Newport News | Virginia | 23606 | United States |
| Novo Nordisk Investigational Site | Milwaukee | Wisconsin | 53209 | United States |
| Novo Nordisk Investigational Site | Johor Bahru | 80100 | Malaysia |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Kuala Selangor | 46150 | Malaysia |
| Novo Nordisk Investigational Site | Guadalajara | Jalisco | 44650 | Mexico |
| Novo Nordisk Investigational Site | Monterrey | 64460 | Mexico |
| Novo Nordisk Investigational Site | Bayamón | 00961 | Puerto Rico |
| Novo Nordisk Investigational Site | Seoul | 08308 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 110-746 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 150-950 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 158-710 | South Korea |
| Novo Nordisk Investigational Site | Suwon | 16247 | South Korea |
| Novo Nordisk Investigational Site | Bangkok | 10400 | Thailand |
| Novo Nordisk Investigational Site | Nakhon Ratchasima | 30000 | Thailand |
| Novo Nordisk Investigational Site | Antalya | 07058 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34096 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34718 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34890 | 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. |
| FG001 |
| IDegAsp Step Wise |
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp Simple | Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration. |
| BG001 | IDegAsp Step Wise | Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration. |
| 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 |
| |||||||||||||||
| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mmol/L |
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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) | 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). | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, week 26 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) | Change from baseline in FPG 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). For 2 subjects baseline values were missing, hence not included in the analysis. | Posted | Mean | Standard Deviation | mmol/L | Week 0, 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. | The safety analysis set included all subjects who received at least one dose of the investigational product. | Posted | Number | Events/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
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| Secondary | Rate of Confirmed Hypoglycaemic Episodes | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. | The safety analysis set included all subjects who received at least one dose of the investigational product. | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
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| Secondary | Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. | The safety analysis set included all subjects who received at least one dose of the investigational product. | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
|
The adverse events were collected in a time frame of 26 weeks + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product.
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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 Simple | Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration. | 1 | 134 | 20 | 134 | ||
| EG001 | IDegAsp Step Wise | Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration. | 6 | 140 | 26 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Thalamic infarction | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | 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 |
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