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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1125-7495 | Other 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 of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg | Experimental |
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| IGlar | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Administered subcutaneously (s.c., under the skin) once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) | Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period. | CGM occured during the last 2 weeks of the 6 weeks treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Interstitial Glucose (IG) Based on 14 Days of CGM | The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period. | CGM monitoring occurred during the last 2 weeks of the 6-week treatment period. |
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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 | Minneapolis | Minnesota | 55416-2699 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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All subjects were on basal-bolus insulin regimens at screening using insulin glargine (IGlar) and either insulin aspart (IAsp) or insulin lispro (ILis). During the run-in period, IGlar 100 U/mL was administered subcutaneously (under the skin) once daily (OD) in the morning (before breakfast) along with IAsp 100 U/mL as meal-time insulin.
The trial was conducted at one site in the United States of America (USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | IDeg/IGlar | The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B. Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period A (6 Weeks) |
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| insulin glargine |
| Drug |
Administered subcutaneously (s.c., under the skin) once daily. |
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| Fasting Plasma Glucose (FPG) |
FPG after 6 weeks of treatment in each treatment period. |
| At the end of each 6 week treatment period. |
| Glycosylated Haemoglobin (HbA1c) | HbA1c after 6 weeks of treatment in each treatment period. | At the end of each 6 week treatment period. |
| Number of Treatment Emergent Adverse Events (AEs) | Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was 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. | Within each week 6 treatment period |
| Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor 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. | Hypoglycemic episodes reported within each 6 week treatment period. |
| FG001 | IGlar/IDeg | The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B. Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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| Period B (6 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Full Analysis Set | The full analysis set (FAS) included all randomised subjects. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mmol/L |
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| Glycosylated Haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
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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 | |||||||||||||||||||||||
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| Primary | Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) | Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period. | The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar. | Posted | Mean | Standard Deviation | hours | CGM occured during the last 2 weeks of the 6 weeks treatment period. |
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| Secondary | Mean Interstitial Glucose (IG) Based on 14 Days of CGM | The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period. | The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar. | Posted | Mean | Standard Deviation | mmol/L | CGM monitoring occurred during the last 2 weeks of the 6-week treatment period. |
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| Secondary | Fasting Plasma Glucose (FPG) | FPG after 6 weeks of treatment in each treatment period. | The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar. | Posted | Mean | Standard Deviation | mmol/L | At the end of each 6 week treatment period. |
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| Secondary | Glycosylated Haemoglobin (HbA1c) | HbA1c after 6 weeks of treatment in each treatment period. | The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar. | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | At the end of each 6 week treatment period. |
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| Secondary | Number of Treatment Emergent Adverse Events (AEs) | Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was 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 (SAS) included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | events | Within each week 6 treatment period |
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| Secondary | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor 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 SAS included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | events | Hypoglycemic episodes reported within each 6 week treatment period. |
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Treatment emergent adverse events were collected during each 6 week treatment period + 7 days follow up.
The SAS 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) |
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| EG000 | IDeg | The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks. | 0 | 23 | 0 | 23 | ||
| EG001 | IGlar | The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. | 0 | 24 | 8 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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Novo Nordisk maintains the right to be informed of plans by any investigator to publish 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 Novo Nordisk before 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 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune 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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| OG001 |
| IGlar |
The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. |
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