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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001712-61 | EudraCT Number | ||
| U1111-1120-5633 | Other Identifier | WHO |
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This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp BID | Experimental |
| |
| BIAsp 30 BID | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued. |
|
| 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 |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment. | Week 0, week 26 |
| Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes |
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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 | Algiers | 16000 | Algeria | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26435365 | Result | Franek E, Haluzik M, Canecki Varzic S, Sargin M, Macura S, Zacho J, Christiansen JS. Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naive adults with Type 2 diabetes. Diabet Med. 2016 Apr;33(4):497-505. doi: 10.1111/dme.12982. Epub 2015 Nov 17. | |
| 26612062 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects continued their metformin monotherapy or metformin in any combination with one of the following OADs: insulin secretagogue (sulphonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, α-glucosidase inhibitors for at least 12 weeks prior to randomisation.
The trial was conducted at 47 sites in 10 countries: Algeria (4), Bulgaria (7), Croatia (5), Czech Republic (4), Germany (5), Poland (5), Romania (5), Slovakia (3), Turkey (2), and Ukraine (7).
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp BID | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal. |
| FG001 | BIAsp 30 BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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 am.
| Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product |
| Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes | The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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. | Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product |
| Change From Baseline in Body Weight | Change from baseline in body weight after 26 weeks of treatment. | Week 0, week 26 |
| Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks | Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L. | Week 26 |
| Number of Treatment Emergent AEs (Adverse Events) | A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator. | Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product |
| Oran |
| 31000 |
| Algeria |
| Novo Nordisk Investigational Site | Sétif | 19000 | Algeria |
| Novo Nordisk Investigational Site | Haskovo | 6300 | Bulgaria |
| Novo Nordisk Investigational Site | Lukovit | 5770 | Bulgaria |
| Novo Nordisk Investigational Site | Plovdiv | 4002 | Bulgaria |
| Novo Nordisk Investigational Site | Rousse | 7000 | Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1233 | Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1431 | Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1606 | Bulgaria |
| Novo Nordisk Investigational Site | Karlovac | 47000 | Croatia |
| Novo Nordisk Investigational Site | Osijek | 31 000 | Croatia |
| Novo Nordisk Investigational Site | Rijeka | 51 000 | Croatia |
| Novo Nordisk Investigational Site | Zadar | 23000 | Croatia |
| Novo Nordisk Investigational Site | Zagreb | 10000 | Croatia |
| Novo Nordisk Investigational Site | Brno | 65691 | Czechia |
| Novo Nordisk Investigational Site | Hradec Králové | 50005 | Czechia |
| Novo Nordisk Investigational Site | Prague | 100 00 | Czechia |
| Novo Nordisk Investigational Site | Prague | 128 08 | Czechia |
| Novo Nordisk Investigational Site | Bochum | 44869 | Germany |
| Novo Nordisk Investigational Site | Hohenmölsen | 06679 | Germany |
| Novo Nordisk Investigational Site | Rehlingen-Siersburg | 66780 | Germany |
| Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach | 66386 | Germany |
| Novo Nordisk Investigational Site | Völklingen | 66333 | Germany |
| Novo Nordisk Investigational Site | Wangen | 88239 | Germany |
| Novo Nordisk Investigational Site | Bialystok | 15-445 | Poland |
| Novo Nordisk Investigational Site | Lublin | 20-044 | Poland |
| Novo Nordisk Investigational Site | Lublin | 20-538 | Poland |
| Novo Nordisk Investigational Site | Mazowieckie | 09-400 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 02-507 | Poland |
| Novo Nordisk Investigational Site | Oradea | Bihor County | 410469 | Romania |
| Novo Nordisk Investigational Site | Bucharest | 020614 | Romania |
| Novo Nordisk Investigational Site | Buzău | 120203 | Romania |
| Novo Nordisk Investigational Site | Galati | 800578 | Romania |
| Novo Nordisk Investigational Site | Sibiu | 550176 | Romania |
| Novo Nordisk Investigational Site | Bratislava | 821 02 | Slovakia |
| Novo Nordisk Investigational Site | Košice | 040 01 | Slovakia |
| Novo Nordisk Investigational Site | Antalya | 07058 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34096 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34890 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Dnipro | 49023 | Ukraine |
| Novo Nordisk Investigational Site | Kyiv | 04114 | Ukraine |
| Novo Nordisk Investigational Site | Lviv | 79010 | Ukraine |
| Novo Nordisk Investigational Site | Poltava | 36003 | Ukraine |
| Novo Nordisk Investigational Site | Poltava | 36011 | Ukraine |
| Novo Nordisk Investigational Site | Vinnytsia | 21010 | Ukraine |
| Novo Nordisk Investigational Site | Zhytomyr | 10002 | Ukraine |
| Result |
| Christiansen JS, Niskanen L, Rasmussen S, Johansen T, Fulcher G. Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. J Diabetes. 2016 Sep;8(5):720-8. doi: 10.1111/1753-0407.12355. Epub 2016 Mar 6. |
| 29451706 | Result | Haluzik M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25. |
| 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. |
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp BID | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal. |
| BG001 | BIAsp 30 BID | Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal. |
| 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 | Subjects aged ≥18 years were enrolled in this study. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Male and female aged ≥18 years were enrolled in this study. | Count of Participants | Participants |
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| Glycosylated Haemoglobin (HbA1c) | Glycosylated haemoglobin (HbA1c) was measured at baseline. | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin |
| ||||||||||||||
| Fasting plasma glucose (FPG) | Fasting plasma glucose (FPG) was measured at baseline. | Mean | Standard Deviation | mmol/L |
| ||||||||||||||
| Body Weight | Body weight was measured at baseline. | 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 From Baseline in HbA1c (Glycosylated Haemoglobin) | Change from baseline in HbA1c after 26 weeks of treatment. | The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin | Week 0, week 26 |
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| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment. | The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. At baseline 195 subjects each in IDegAsp BID and BIAsp 30 BID treatment group were analysed. | Posted | Mean | Standard Deviation | mmol/L | Week 0, week 26 |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes | The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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 am. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | episodes | Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes | The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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 or its comparator. | Posted | Number | episodes | Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight | Change from baseline in body weight after 26 weeks of treatment. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | kg | Week 0, week 26 |
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| Secondary | Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks | Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L. | The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Data for 15 subjects were excluded, as only subjects exposed for at least 12 weeks were included in this measurement. | Posted | Number | participants | Week 26 |
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| Secondary | Number of Treatment Emergent AEs (Adverse Events) | A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | events | Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product |
|
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From the first trial-related activity after the subject had signed the informed consent (Week -1) and until post-treatment follow-up period (Week 27).
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 BID | Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal. | 13 | 196 | 15 | 196 | ||
| EG001 | BIAsp 30 BID | Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal. | 10 | 195 | 7 | 195 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery insufficiency | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
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| Meningitis pneumococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Peritonsillar abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Colon cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | 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
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| ID | Term |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
Not provided
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| Male |
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| Units | Counts |
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| Participants |
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