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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-2441 | Other Identifier | WHO | |
| JapicCTI-101039 | Registry Identifier | JAPIC |
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This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg OD | Experimental |
| |
| IGlar OD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline in HbA1c after 26 weeks of treatment | Week 0, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Confirmed Hypoglycaemic Episodes | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure 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. |
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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 | Shatin, New Territories | Hong Kong | ||||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26121451 | Background | Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29. | |
| 23130654 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects continued on their current treatment with oral antidiabetic drug(s) (OAD(s) treatment except for dipeptyl peptidase-4 (DPP-4) inhibitors, at the pre-randomisation dose level and dosing frequency.
The trial was conducted at 52 sites in 6 countries: Hong Kong (1), Japan (12), Malaysia (8), South Korea (19), Thailand (6) and Taiwan (6)
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| ID | Title | Description |
|---|---|---|
| FG000 | IDeg OD | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted. |
| FG001 | IGlar OD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin glargine | Drug | Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted |
|
| 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 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 26 + 7 days follow up |
| Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast. | Week 26 |
| Chuo-ku, Tokyo |
| 103 0002 |
| Japan |
| Novo Nordisk Investigational Site | Kamakura-shi, Kanagawa | 247 0072 | Japan |
| Novo Nordisk Investigational Site | Kawasaki-shi | 212 0024 | Japan |
| Novo Nordisk Investigational Site | Miyazaki | 880 0034 | 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 | Ogawa | 355 0321 | 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-shi, Hokkaido | 060-0001 | Japan |
| Novo Nordisk Investigational Site | Takatsuki-shi, Osaka | 569 1096 | Japan |
| Novo Nordisk Investigational Site | Cheras | 56000 | Malaysia |
| Novo Nordisk Investigational Site | George Town | 10459 | Malaysia |
| Novo Nordisk Investigational Site | Georgetown, Penang | 10450 | Malaysia |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Kuala Lumpur | 50586 | Malaysia |
| Novo Nordisk Investigational Site | Kuala Lumpur | 59100 | Malaysia |
| Novo Nordisk Investigational Site | Kuala Selangor | 46150 | Malaysia |
| Novo Nordisk Investigational Site | Putrajaya | 62250 | Malaysia |
| Novo Nordisk Investigational Site | Bucheon-si | 14647 | South Korea |
| Novo Nordisk Investigational Site | Busan | 614-735 | South Korea |
| Novo Nordisk Investigational Site | Goyang | 10380 | South Korea |
| Novo Nordisk Investigational Site | Goyang | 410-719 | South Korea |
| Novo Nordisk Investigational Site | Incheon | 400-103 | South Korea |
| Novo Nordisk Investigational Site | Jeonju | 561-712 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 110-746 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 120-752 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 130-701 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 133-792 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 135-239 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 135-720 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 139-827 | 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 | Suwon | 16499 | South Korea |
| Novo Nordisk Investigational Site | Wŏnju | 220-701 | South Korea |
| Novo Nordisk Investigational Site | Yangsan | 626-770 | South Korea |
| Novo Nordisk Investigational Site | Banqiao District | 220 | Taiwan |
| Novo Nordisk Investigational Site | Changhua | 500 | Taiwan |
| Novo Nordisk Investigational Site | Chiayi City | 600 | Taiwan |
| Novo Nordisk Investigational Site | Kaohsiung City | 813 | Taiwan |
| Novo Nordisk Investigational Site | Kaoshiung | 807 | Taiwan |
| Novo Nordisk Investigational Site | Taichung | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 104 | Taiwan |
| Novo Nordisk Investigational Site | Bangkok | 10330 | Thailand |
| Novo Nordisk Investigational Site | Bangkok | 10400 | Thailand |
| Novo Nordisk Investigational Site | Bangkoknoi, Bangkok | 10700 | Thailand |
| Novo Nordisk Investigational Site | Chiang Mai | 50200 | Thailand |
| Novo Nordisk Investigational Site | Nakhon Ratchasima | 30000 | Thailand |
| Novo Nordisk Investigational Site | Songkhla | 90110 | Thailand |
| Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3. |
| 26484727 | Result | Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13. |
| 24170235 | Result | Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2. |
| 26232910 | Result | Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18. |
| 26663320 | Result | Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8. |
| 25081590 | Result | Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1. |
| 24812526 | Result | Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014. |
| 24843715 | Result | Onishi Y, Iwamoto Y, Yoo SJ, Clauson P, Tamer SC, Park S. Insulin degludec compared with insulin glargine in insulin-naive patients with type 2 diabetes: A 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Investig. 2013 Nov 27;4(6):605-12. doi: 10.1111/jdi.12102. Epub 2013 Jun 3. |
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
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 |
|---|---|---|
| BG000 | IDeg OD | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted. |
| BG001 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
| |||||||||||||||
| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mmol/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline in HbA1c after 26 weeks of treatment | The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 0, Week 26 |
|
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| ||||||||||||||||||||||||||||
| Secondary | Rate of Confirmed Hypoglycaemic Episodes | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure 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 (SAS) 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 |
|
| ||||||||||||||||||||||||||||||
| 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 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 26 + 7 days follow up |
| |||||||||||||||||||||||||||||||
| Secondary | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast. | The FAS included all randomised subjects.The missing data is imputed using last observation carried forward (LOCF). For 25 subjects all 9-point SMPG values were missing. | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
|
|
The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes 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 | IDeg OD | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted. | 8 | 284 | 58 | 284 | ||
| EG001 | IGlar OD | Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted. | 8 | 146 | 39 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cataract operation complication | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ureteric calculus removal | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinopathy | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | 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 |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
| 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
| Male |
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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