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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-8802 | Other Identifier | WHO |
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This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGlar/IDeg | Experimental |
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| IDeg 3TW | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (Glycosylated Haemoglobin) | HbA1C at week 4 and 16 | Week 4 and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) | FPG at week 4 and 16 | Week 4 and Week 16 |
| Change in Body Weight | Change from baseline in body weight after week 4 and after week 16 |
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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 Clinical Trial Call Center | Goodyear | Arizona | 85395 | United States | ||
| Novo Nordisk Clinical Trial Call Center |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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The trial was conducted on subjects with type 2 diabetes mellitus currently treated with IGlar once daily (OD) and oral antidiabetic drug (OAD) therapy.
The trial was conducted at 27 sites in the United States of America (U.S.)
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| ID | Title | Description |
|---|---|---|
| FG000 | IGlar/IDeg | Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin glargine | Drug | Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec |
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| Week 0, Week 4, Week 16 |
| Rate of Treatment Emergent Adverse Events (AEs) | Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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 | Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) |
| 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 with a confirmed plasma glucose value of less than 3.1 mmol/L. | Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) |
| 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 with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. | Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Novo Nordisk Clinical Trial Call Center | Anaheim | California | 92801 | United States |
| Novo Nordisk Clinical Trial Call Center | Chino | California | 91710 | United States |
| Novo Nordisk Clinical Trial Call Center | Concord | California | 94520 | United States |
| Novo Nordisk Clinical Trial Call Center | Fresno | California | 93720 | United States |
| Novo Nordisk Clinical Trial Call Center | Greenbrae | California | 94904 | United States |
| Novo Nordisk Clinical Trial Call Center | Palm Springs | California | 92262-6972 | United States |
| Novo Nordisk Clinical Trial Call Center | Kissimmee | Florida | 34741 | United States |
| Novo Nordisk Clinical Trial Call Center | Chicago | Illinois | 60616 | United States |
| Novo Nordisk Clinical Trial Call Center | Metairie | Louisiana | 70002 | United States |
| Novo Nordisk Clinical Trial Call Center | Metairie | Louisiana | 70006-2930 | United States |
| Novo Nordisk Clinical Trial Call Center | Omaha | Nebraska | 68114 | United States |
| Novo Nordisk Clinical Trial Call Center | Henderson | Nevada | 89052-2649 | United States |
| Novo Nordisk Clinical Trial Call Center | Dover | New Hampshire | 03820 | United States |
| Novo Nordisk Clinical Trial Call Center | Nashua | New Hampshire | 03063 | United States |
| Novo Nordisk Clinical Trial Call Center | Lawrenceville | New Jersey | 08648 | United States |
| Novo Nordisk Clinical Trial Call Center | Toms River | New Jersey | 08755-8050 | United States |
| Novo Nordisk Clinical Trial Call Center | Albany | New York | 12206 | United States |
| Novo Nordisk Clinical Trial Call Center | Charlotte | North Carolina | 28209 | United States |
| Novo Nordisk Clinical Trial Call Center | Melrose Park | Pennsylvania | 19027 | United States |
| Novo Nordisk Clinical Trial Call Center | Pittsburgh | Pennsylvania | 15224-2215 | United States |
| Novo Nordisk Clinical Trial Call Center | Chattanooga | Tennessee | 37411 | United States |
| Novo Nordisk Clinical Trial Call Center | Kingsport | Tennessee | 37660 | United States |
| Novo Nordisk Clinical Trial Call Center | Austin | Texas | 78731 | United States |
| Novo Nordisk Clinical Trial Call Center | Fort Worth | Texas | 76113 | United States |
| Novo Nordisk Clinical Trial Call Center | Olympia | Washington | 98502 | United States |
| Exposed |
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| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Full Analysis set (FAS)-Includes 129 subjects only as 13 subjects did not receive IDeg.
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| ID | Title | Description |
|---|---|---|
| BG000 | IGlar/IDeg | Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment. |
| 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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| HbA1c (glycosylated haemoglobin) at baseline | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
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| Fasting plasma glucose (FPG) at baseline | Mean | Standard Deviation | mmol/L |
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| Body weight 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 | HbA1c (Glycosylated Haemoglobin) | HbA1C at week 4 and 16 | FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Week 4 and Week 16 |
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| Secondary | Fasting Plasma Glucose (FPG) | FPG at week 4 and 16 | FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment | Posted | Mean | Standard Deviation | mmol/L | Week 4 and Week 16 |
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| Secondary | Change in Body Weight | Change from baseline in body weight after week 4 and after week 16 | Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using LOCF (last observation carried forward) | Posted | Mean | Standard Deviation | kg | Week 0, Week 4, Week 16 |
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| Secondary | Rate of Treatment Emergent Adverse Events (AEs) | Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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 | Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | events per 100 patient years | Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) |
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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 with a confirmed plasma glucose value of less than 3.1 mmol/L. | Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | episodes per 100 patient years | Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) |
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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 with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. | Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator | Posted | Number | episodes per 100 patient years | Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) |
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The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
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 | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IGlar/IDeg | Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment. | 3 | 142 | 0 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis (IGlar) | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment | (week 4) (N=142) |
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| Cholelithiaisis (IDeg) | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment | (week 16) (N=129) |
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| Cholelithiasis (Total) | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment | (N=142) |
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| Lumbar spinal stenosis (IGlar) | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment | (week 4) (N=142) |
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| Lumbar spinal stenosis (IDeg) | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment | (week 16) (N=129) |
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| Lumbar spinal stenosis (Total) | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment | (N=142) |
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| Carotid artery occlusion (IGlar) | Nervous system disorders | MedDRA 13.1 | Systematic Assessment | (week 4)(N=142) |
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| Carotid artery occlusion (IDeg) | Nervous system disorders | MedDRA 13.1 | Systematic Assessment | (week 16)(N=129) |
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| Carotid artery occlusion (Total) | Nervous system disorders | MedDRA 13.1 | Systematic Assessment | (N=142) |
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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 |
| 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 |
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