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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-0616 | Other Identifier | WHO | |
| 2010-022337-29 | EudraCT Number |
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This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg Simple | Experimental |
| |
| IDeg Step wise | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Injected subcutaneously (under the skin) once daily. Dose 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 |
|---|---|---|
| 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 | Birmingham | Alabama | 35216 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23812875 | Result | Philis-Tsimikas A, Brod M, Niemeyer M, Ocampo Francisco AM, Rothman J. Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use). Adv Ther. 2013 Jun;30(6):607-22. doi: 10.1007/s12325-013-0036-1. Epub 2013 Jun 29. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects continued on metformin treatment at the pre-randomisation dose level and dosing frequency.
The trial was conducted at 43 sites in 4 countries: Finland (5), Germany (6), Spain (6) and United States of America (26).
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| ID | Title | Description |
|---|---|---|
| FG000 | IDeg Simple | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single 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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| insulin degludec | Drug | Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner. |
|
| 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 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 26 + 7 days follow up |
| Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Observed 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 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Novo Nordisk Investigational Site | Anaheim | California | 92801 | United States |
| Novo Nordisk Investigational Site | La Jolla | California | 92037 | United States |
| Novo Nordisk Investigational Site | Mission Hills | California | 91345 | United States |
| Novo Nordisk Investigational Site | National City | California | 91950 | United States |
| Novo Nordisk Investigational Site | North Hollywood | California | 91606 | United States |
| Novo Nordisk Investigational Site | San Diego | California | 92111 | United States |
| Novo Nordisk Investigational Site | Golden | Colorado | 80401 | United States |
| Novo Nordisk Investigational Site | Kissimmee | Florida | 34741 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33603 | United States |
| Novo Nordisk Investigational Site | Columbus | Georgia | 31909 | United States |
| Novo Nordisk Investigational Site | Springfield | Illinois | 62711 | United States |
| Novo Nordisk Investigational Site | Evansville | Indiana | 47714 | United States |
| Novo Nordisk Investigational Site | Slidell | Louisiana | 70461-4231 | United States |
| Novo Nordisk Investigational Site | Billings | Montana | 59102 | United States |
| Novo Nordisk Investigational Site | Staten Island | New York | 10301 | United States |
| Novo Nordisk Investigational Site | Greensboro | North Carolina | 27408 | United States |
| Novo Nordisk Investigational Site | Franklin | Ohio | 45005 | United States |
| Novo Nordisk Investigational Site | Melrose Park | Pennsylvania | 19027 | United States |
| Novo Nordisk Investigational Site | East Providence | Rhode Island | 02914 | United States |
| Novo Nordisk Investigational Site | Humboldt | Tennessee | 38343 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77095 | United States |
| Novo Nordisk Investigational Site | Killeen | Texas | 76543-5600 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78224 | United States |
| Novo Nordisk Investigational Site | Ogden | Utah | 84403 | United States |
| Novo Nordisk Investigational Site | St. George | Utah | 84790 | United States |
| Novo Nordisk Investigational Site | Helsinki | 00260 | Finland |
| Novo Nordisk Investigational Site | Kerava | FI-04200 | Finland |
| Novo Nordisk Investigational Site | Tampere | 33210 | Finland |
| Novo Nordisk Investigational Site | Turku | 20520 | Finland |
| Novo Nordisk Investigational Site | Turku | FI-20100 | Finland |
| Novo Nordisk Investigational Site | Berlin | 12163 | Germany |
| Novo Nordisk Investigational Site | Friedrichsthal | 66299 | Germany |
| Novo Nordisk Investigational Site | Hohenmölsen | 06679 | Germany |
| Novo Nordisk Investigational Site | Münster | 48145 | Germany |
| Novo Nordisk Investigational Site | Neuwied | 56564 | Germany |
| Novo Nordisk Investigational Site | Völklingen | 66333 | Germany |
| Novo Nordisk Investigational Site | Almería | 04001 | Spain |
| Novo Nordisk Investigational Site | Antequera | 29200 | Spain |
| Novo Nordisk Investigational Site | Gijón | 33206 | Spain |
| Novo Nordisk Investigational Site | Málaga | 29006 | Spain |
| Novo Nordisk Investigational Site | Palma de Mallorca | 07014 | Spain |
| Novo Nordisk Investigational Site | Palma de Mallorca | 07198 | Spain |
| Novo Nordisk Investigational Site | Pozuelo de Alarcón | 28223 | Spain |
| FG001 |
| IDeg Step Wise |
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours 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 | IDeg Simple | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration. |
| BG001 | IDeg Step Wise | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours 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 |
|
| 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 |
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| 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 was 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 was imputed using last observation carried forward (LOCF). For 7 subjects baseline values were missing. | 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 | 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 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. | 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 | Observed 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. | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 26 + 7 days follow up |
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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 | IDeg Simple | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration. | 5 | 110 | 17 | 110 | ||
| EG001 | IDeg Step Wise | Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours 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. | 7 | 111 | 14 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastrointestinal angiodysplasia | Congenital, familial and genetic disorders | MedDRA 14.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
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| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Panic attack | Psychiatric 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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| Headache | Nervous system disorders | 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 |
|---|---|
| C571886 | insulin degludec |
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