Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1123-0547 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a: Lira-depot 2.25 mg | Experimental |
| |
| Cohort 2a: Lira-depot 6.75 mg | Experimental |
| |
| Cohort 3a: Lira-depot 15 mg | Experimental |
| |
| Cohort 4a: Lira-depot 30 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide-depot | Drug | Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) | TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect. | Day 0 and up to 21 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot | Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose | |
| Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Evansville | Indiana | 47710 | United States |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
It was a Novo Nordisk business decision, and not a decision due to safety concerns, not to continue the development of liraglutide depot. Therefore cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done. So no subjects were enrolled for the outcome measure 6.
The trial was conducted at one site in Evansville, Indiana, USA.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1a: Lira-depot 2.25 mg | In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered. |
| FG001 | Cohort 2a: Lira-depot 6.75 mg | In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered. |
| FG002 | Cohort 3a: Lira-depot 15 mg | In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered. |
| FG003 | Cohort 4a: Lira-depot 30 mg | In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered. |
| FG004 | Placebo | In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1a: Lira-depot 2.25 mg | In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered. |
| BG001 | Cohort 2a: Lira-depot 6.75 mg | In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Treatment Emergent Adverse Events (TEAEs) | TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect. | The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'. | Posted | Number | events | Day 0 and up to 21 days after treatment |
|
The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1a: Lira-depot 2.25 mg | In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin). |
|
| Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose |
| Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity | Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose |
| Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment | 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose |
| Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment | 0 to 168 hours after dosing |
| Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up | Day 0 and Day 21 |
| BG002 | Cohort 3a: Lira-depot 15 mg | In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered. |
| BG003 | Cohort 4a: Lira-depot 30 mg | In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered. |
| BG004 | Placebo | In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.). |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered. |
| OG001 | Cohort 2a: Lira-depot 6.75 mg | In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered. |
| OG002 | Cohort 3a: Lira-depot 15 mg | In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered. |
| OG003 | Cohort 4a: Lira-depot 30 mg | In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered. |
| OG004 | Placebo | In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.). |
|
|
| Secondary | Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot | Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L | Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose |
|
|
|
| Secondary | Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot | Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose |
|
|
|
| Secondary | Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity | Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. This evaluation was not done on placebo cohort. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol.h/L | Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose |
|
|
|
| Secondary | Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment | Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol.h/L | 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose |
|
|
|
| Secondary | Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment | Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done. | Posted | 0 to 168 hours after dosing |
|
|
| Secondary | Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up | The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'. | Posted | Number | participants | Day 0 and Day 21 |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Cohort 2a: Lira-depot 6.75 mg | In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered. | 0 | 6 | 3 | 6 |
| EG002 | Cohort 3a: Lira-depot 15 mg | In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered. | 0 | 6 | 3 | 6 |
| EG003 | Cohort 4a: Lira-depot 30 mg | In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered. | 0 | 5 | 5 | 5 |
| EG004 | Placebo | In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.). | 0 | 8 | 5 | 8 |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site vasculitis | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
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.
| Negative |
|