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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-2518 | Registry Identifier | WHO |
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This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg 200 U/mL | Experimental |
| |
| IDeg 100 U/mL | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment. Dose was individually adjusted. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline in HbA1c after 22 weeks of treatment | Week 0, Week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | Change from baseline in FPG after 22 weeks of treatment. | Week 0, Week 22 |
| 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 | Huntsville | Alabama | 35801 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24518180 | Result | Bode BW, Chaykin LB, Sussman AM, Warren ML, Niemeyer M, Rabol R, Rodbard HW. Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare). Endocr Pract. 2014 Aug;20(8):785-91. doi: 10.4158/EP13411.OR. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects who were treated with basal insulin in combination with unchanged dosing of oral antidiabetic drug treatment (e.g. metformin, pioglitazone or DPP-IV inhibitor) in any approved dose or combination at unchanged dosing for at least 12 weeks prior to randomisation in a 1:1 manner to IDeg 200 U/mL or IDeg.
The trial was conducted at 44 sites within United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | IDeg 200 U/mL | Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin degludec | Drug | Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment. Dose was individually adjusted. |
|
| Week 0 to Week 22 + 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 22 + 7 days follow up |
| Rate of Nocturnal 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. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. | Week 0 to Week 22 + 7 days follow up |
| Goodyear |
| Arizona |
| 85395 |
| United States |
| Novo Nordisk Investigational Site | Mesa | Arizona | 85213 | United States |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85018 | United States |
| Novo Nordisk Investigational Site | Concord | California | 94520 | United States |
| Novo Nordisk Investigational Site | Greenbrae | California | 94904 | United States |
| Novo Nordisk Investigational Site | Montclair | California | 91763 | United States |
| Novo Nordisk Investigational Site | National City | California | 91950 | United States |
| Novo Nordisk Investigational Site | Palm Springs | California | 92262 | United States |
| Novo Nordisk Investigational Site | Bradenton | Florida | 34201 | United States |
| Novo Nordisk Investigational Site | Clearwater | Florida | 33765 | United States |
| Novo Nordisk Investigational Site | Kissimmee | Florida | 34741 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33135 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33603 | United States |
| Novo Nordisk Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30318 | United States |
| Novo Nordisk Investigational Site | Springfield | Illinois | 62711 | United States |
| Novo Nordisk Investigational Site | Evansville | Indiana | 47714 | United States |
| Novo Nordisk Investigational Site | Metairie | Louisiana | 70002 | United States |
| Novo Nordisk Investigational Site | Slidell | Louisiana | 70461-4231 | United States |
| Novo Nordisk Investigational Site | Rockville | Maryland | 20852 | United States |
| Novo Nordisk Investigational Site | Waltham | Massachusetts | 02453-2717 | United States |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48235 | United States |
| Novo Nordisk Investigational Site | Jefferson City | Missouri | 65109 | United States |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68114 | United States |
| Novo Nordisk Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Novo Nordisk Investigational Site | Toms River | New Jersey | 08755-8050 | United States |
| Novo Nordisk Investigational Site | Staten Island | New York | 10301 | United States |
| Novo Nordisk Investigational Site | West Seneca | New York | 14224 | United States |
| Novo Nordisk Investigational Site | Greensboro | North Carolina | 27408 | United States |
| Novo Nordisk Investigational Site | Greenville | North Carolina | 27834 | United States |
| Novo Nordisk Investigational Site | Canton | Ohio | 44718 | 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 | Brentwood | Tennessee | 37027 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37411 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75246 | United States |
| Novo Nordisk Investigational Site | Hurst | Texas | 76054 | United States |
| Novo Nordisk Investigational Site | Irving | Texas | 75061-2210 | United States |
| Novo Nordisk Investigational Site | Round Rock | Texas | 78681 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78224 | United States |
| Novo Nordisk Investigational Site | Olympia | Washington | 98502 | United States |
| Novo Nordisk Investigational Site | Renton | Washington | 98057 | United States |
| FG001 | IDeg | Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IDeg 200 U/mL | Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day. |
| BG001 | IDeg | Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day. |
| 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 |
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| 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 |
|
| 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 22 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 22 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) | Change from baseline in FPG after 22 weeks of treatment. | The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 5 subjects baseline values were missing. | Posted | Mean | Standard Deviation | mmol/L | Week 0, Week 22 |
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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 or its comparator. | Posted | Number | Events/100 years of patient exposure | Week 0 to Week 22 + 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 or its comparator. | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 22 + 7 days follow up |
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| Secondary | Rate of Nocturnal 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. 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 or its comparator. | Posted | Number | Episodes/100 years of patient exposure | Week 0 to Week 22 + 7 days follow up |
|
The adverse events were collected in a time frame of 22 weeks + 7 days follow up.
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 | IDeg 200 U/mL | Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day. | 9 | 184 | 45 | 184 | ||
| EG001 | IDeg | Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day. | 11 | 187 | 26 | 187 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Heat stroke | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Tongue neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Alcohol abuse | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Drug abuse | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | 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 |
|---|---|
| C571886 | insulin degludec |
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| Male |
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