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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013090-18 | EudraCT Number | ||
| U1111-1114-8952 | Other Identifier | WHO |
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The decision to close the NN2211-3619 trial was based on the very low recruitment rate as well as challenges relating to trial execution and study completion.
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This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental |
| |
| Liraglutide placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Dose escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide dose for 52 weeks. Injected subcutaneously(under the skin) once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant | Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant. | At week 52 after initial transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hypoglycaemic Episodes | A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG<3.1 mmol/L [56 mg/dL]) or severe (subject unable to treat himself/herself). | During week 0 to week 52 |
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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 | Duarte | California | 91010 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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All the subjects were on pre-trial insulin at screening.
The trial was conducted at 3 sites in 3 countries:
Canada: 1 site; Switzerland: 1 site; US: 1 site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide | Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject. |
| FG001 | Liraglutide Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | Dose escalation escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide placebo dose for 52 weeks. Injected subcutaneously (under the skin) once daily. |
|
| Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events | Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events | From week 0 to week 52 after initial transplantation |
| Proportion of Insulin-Independent Subjects | Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation | At 52 weeks after initial transplantation |
| Change in Islet Cell Yield During Culture | Change in islet cell yield from pre-culture to post-culture | From 0 hours pre-culture to 24 hours to 72 hours |
| Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS) | Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, at 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo) | At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo) |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02114 | United States |
| Novo Nordisk Investigational Site | Madison | Wisconsin | 53792-0001 | United States |
| Novo Nordisk Investigational Site | Edmonton | Alberta | T6G 2C8 | Canada |
| Novo Nordisk Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Novo Nordisk Investigational Site | Besançon | 25030 | France |
| Novo Nordisk Investigational Site | Grenoble | 38043 | France |
| Novo Nordisk Investigational Site | Lille | 59037 | France |
| Novo Nordisk Investigational Site | Montpellier | 34295 | France |
| Novo Nordisk Investigational Site | Strasbourg | 67091 | France |
| Novo Nordisk Investigational Site | Dresden | 01307 | Germany |
| Novo Nordisk Investigational Site | Geneva | 1211 | Switzerland |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| Novo Nordisk Investigational Site | Headington | OX3 7LE | United Kingdom |
| Novo Nordisk Investigational Site | London | SE5 9RS | United Kingdom |
Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide | Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject. |
| BG001 | Liraglutide Placebo | Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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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 | Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant | Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant. | Full analysis set (FAS) - all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed. | Posted | At week 52 after initial transplantation |
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| Secondary | Number of Hypoglycaemic Episodes | A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG<3.1 mmol/L [56 mg/dL]) or severe (subject unable to treat himself/herself). | Full analysis set (FAS) - all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed. | Posted | During week 0 to week 52 |
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| Secondary | Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events | Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events | Full analysis set (FAS) - all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed. | Posted | From week 0 to week 52 after initial transplantation |
|
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| Secondary | Proportion of Insulin-Independent Subjects | Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation | Full analysis set (FAS) - all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed. | Posted | At 52 weeks after initial transplantation |
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| Secondary | Change in Islet Cell Yield During Culture | Change in islet cell yield from pre-culture to post-culture | Full analysis set (FAS) - all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed. | Posted | From 0 hours pre-culture to 24 hours to 72 hours |
|
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| Secondary | Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS) | Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, at 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo) | Full analysis set (FAS) - all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed. | Posted | At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo) |
|
Adverse events were collected from week 0 to week 52.
Safety analysis set includes all subjects who received at least one dose of the trial 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 | Liraglutide | Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject. | 0 | 2 | 2 | 2 | ||
| EG001 | Liraglutide Placebo | Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject. | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | 16.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | 16.0 | Systematic Assessment |
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| Computerised tomogram abnormal | Investigations | 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | 16.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | 16.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
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Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no results are available.
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 |
| 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 |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| >=65 years |
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| Male |
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| Units | Counts |
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| Participants |
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