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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1281-5677 | Other Identifier | World Health Organization (WHO) |
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This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile. Participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. The study will last for about 24 weeks. Participants will have 4 clinic visits and 2 phone calls. Participants will have 3 laboratory tests during the study (blood and urine samples).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Participants will receive semaglutide subcutaneous (s.c.) injection once weekly in a dose escalation manner for 24 weeks: 0.25 milligrams (mg) (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants will receive semaglutide s.c. injection once weekly in a dose escalation manner for 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Number of adverse events from baseline (Day 1) to week 24 is presented. An adverse event is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | From baseline (Day 1) up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Change in glycosylated haemoglobin (HbA1c) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicios Médicos Godoy Limitada | Santiago, Región Metropolitana | 7500710 | Chile | |||
| Hospital San Juan de Dios_Santiago, Región Metropolitana |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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The trial was conducted at 3 sites in Chile.
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| ID | Title | Description |
|---|---|---|
| FG000 | Semaglutide | Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams [mg], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Full analysis set (FAS) included all participants exposed to the study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Semaglutide | Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams [mg], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24). |
| 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 |
| 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 Adverse Events (AEs) | Number of adverse events from baseline (Day 1) to week 24 is presented. An adverse event is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | Full analysis set (FAS) included all participants exposed to the study product. | Posted | Number | Events | From baseline (Day 1) up to 24 weeks |
|
Baseline (Day 1) up to Week 24
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date (or increase in severity) during on-treatment observation period. Full analysis set (FAS) included all participants exposed to the study product.
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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 | Semaglutide | Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams [mg], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2022 | Jan 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2022 | Jan 16, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Baseline (week 1), week 24 |
| Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No] | Participants achieving HbA1c less than 7.0% (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | From baseline (week 1) to week 24 |
| Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)] | Change in fasting plasma glucose (FPG) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Change in Body Weight (Kilogram [Kg]) | Change in body weight from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Change in Waist Circumference [Centimeter (cm)] | Change in waist circumference from baseline (week 1) to week 24 is presented. Waist circumference is defined as the minimal abdominal circumference located midway between the lower rib margin and the iliac crest. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No) | Participants achieving greater than or equal (≥) 5% weight reduction (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | From baseline (week 1) to week 24 |
| Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No) | Participants achieving greater than or equal (≥) 10% weight reduction (Yes/No) from baseline (week 1) to week is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | From baseline (week 1) to week 24 |
| Change in Total Cholesterol (mg/dL) | Change in total cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) | Change in low density lipoprotein (LDL) cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) | Change in high density lipoprotein (HDL) cholesterol (mg/dL) cholesterol from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Change in Triglycerides (mg/dL) | Change in triglycerides (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Change in Estimated Glomerular Filtration Rate (eGFR) [Millilitre Per Minute (mL/Min) Per 1.73 Square Meter (m^2)] | Change in estimated glomerular filtration rate (eGFR) [millilitre per minute (mL/min) per 1.73 square meter (m^2)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)] | Change in Urine Albumin-Creatinine Ratio (UACR) [milligram per gram (mg/g)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Participants Discontinued Due to Adverse Events (Treatment Discontinuation) | Participants discontinued due to adverse events (treatment discontinuation) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | From baseline (week 1) to week 24 |
| Number of Severe Hypoglycaemic Episodes | Number of severe hypoglycaemic episodes from baseline (week 1) to week 24 is presented. Hypoglycaemic episodes were classified as severe if there was no specific glucose threshold but were associated with severe cognitive impairment requiring external assistance for recovery. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit. | From baseline (week 1) to week 24 |
| Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | Number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit. | From baseline (week 1) to week 24 |
| Number of Serious Adverse Events (SAEs) | Number of serious adverse events (SAEs) from baseline (week 1) to week 24 is presented. An SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; important medical event. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | From baseline (week 1) to week 24 |
| Number of Adverse Reactions (ARs) | Number of adverse reactions (ARs) from baseline (week 1) to week 24 is presented. Adverse reaction is an undesired effect of a drug or other type of treatment that can range from mild to severe and can be life-threatening. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | From baseline (week 1) to week 24 |
| Number of Serious Adverse Reactions (SARs) | Number of serious adverse reactions (SARs) from baseline (week 1) to week 24 is presented. Serious adverse reaction is an adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | From baseline (week 1) to week 24 |
| Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant | Number of suspected unexpected serious adverse reactions (SUSARs) per participant from baseline (week 1) to week 24 is presented. SUSAR is a serious adverse event which is unexpected and regarded as possibly or probably related to the trial product. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | From baseline (week 1) to week 24 |
| Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment | Change from baseline in heart rate (pulse) after 24 weeks of treatment is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Baseline (week 1), week 24 |
| Santiago, Región Metropolitana |
| 8350429 |
| Chile |
| Hospital Padre Hurtado | Santiago, Región Metropolitana | 8880465 | Chile |
| Withdrawal by Subject |
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| Adverse Event |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams [mg], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24). |
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| Secondary | Change in Glycosylated Haemoglobin (HbA1c) | Change in glycosylated haemoglobin (HbA1c) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | Percentage of HbA1c | Baseline (week 1), week 24 |
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| Secondary | Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No] | Participants achieving HbA1c less than 7.0% (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Count of Participants | Participants | From baseline (week 1) to week 24 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)] | Change in fasting plasma glucose (FPG) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | mg/dL | Baseline (week 1), week 24 |
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| Secondary | Change in Body Weight (Kilogram [Kg]) | Change in body weight from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | Kg | Baseline (week 1), week 24 |
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| Secondary | Change in Waist Circumference [Centimeter (cm)] | Change in waist circumference from baseline (week 1) to week 24 is presented. Waist circumference is defined as the minimal abdominal circumference located midway between the lower rib margin and the iliac crest. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | cm | Baseline (week 1), week 24 |
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| Secondary | Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No) | Participants achieving greater than or equal (≥) 5% weight reduction (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Count of Participants | Participants | From baseline (week 1) to week 24 |
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| Secondary | Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No) | Participants achieving greater than or equal (≥) 10% weight reduction (Yes/No) from baseline (week 1) to week is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Count of Participants | Participants | From baseline (week 1) to week 24 |
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| Secondary | Change in Total Cholesterol (mg/dL) | Change in total cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | mg/dL | Baseline (week 1), week 24 |
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| Secondary | Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) | Change in low density lipoprotein (LDL) cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | mg/dL | Baseline (week 1), week 24 |
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| Secondary | Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) | Change in high density lipoprotein (HDL) cholesterol (mg/dL) cholesterol from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | mg/dL | Baseline (week 1), week 24 |
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| Secondary | Change in Triglycerides (mg/dL) | Change in triglycerides (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | mg/dL | Baseline (week 1), week 24 |
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| Secondary | Change in Estimated Glomerular Filtration Rate (eGFR) [Millilitre Per Minute (mL/Min) Per 1.73 Square Meter (m^2)] | Change in estimated glomerular filtration rate (eGFR) [millilitre per minute (mL/min) per 1.73 square meter (m^2)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | mL/min per 1.73 m^2 | Baseline (week 1), week 24 |
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| Secondary | Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)] | Change in Urine Albumin-Creatinine Ratio (UACR) [milligram per gram (mg/g)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | mg/g | Baseline (week 1), week 24 |
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| Secondary | Participants Discontinued Due to Adverse Events (Treatment Discontinuation) | Participants discontinued due to adverse events (treatment discontinuation) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | Full analysis set (FAS) included all participants exposed to the study product. | Posted | Count of Participants | Participants | From baseline (week 1) to week 24 |
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| Secondary | Number of Severe Hypoglycaemic Episodes | Number of severe hypoglycaemic episodes from baseline (week 1) to week 24 is presented. Hypoglycaemic episodes were classified as severe if there was no specific glucose threshold but were associated with severe cognitive impairment requiring external assistance for recovery. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. | Posted | Number | Episodes | From baseline (week 1) to week 24 |
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| Secondary | Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | Number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. | Posted | Number | Episodes | From baseline (week 1) to week 24 |
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| Secondary | Number of Serious Adverse Events (SAEs) | Number of serious adverse events (SAEs) from baseline (week 1) to week 24 is presented. An SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; important medical event. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | Full analysis set (FAS) included all participants exposed to the study product. | Posted | Number | Events | From baseline (week 1) to week 24 |
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| Secondary | Number of Adverse Reactions (ARs) | Number of adverse reactions (ARs) from baseline (week 1) to week 24 is presented. Adverse reaction is an undesired effect of a drug or other type of treatment that can range from mild to severe and can be life-threatening. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | Full analysis set (FAS) included all participants exposed to the study product. | Posted | Number | Events | From baseline (week 1) to week 24 |
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| Secondary | Number of Serious Adverse Reactions (SARs) | Number of serious adverse reactions (SARs) from baseline (week 1) to week 24 is presented. Serious adverse reaction is an adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | Full analysis set (FAS) included all participants exposed to the study product. | Posted | Number | Events | From baseline (week 1) to week 24 |
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| Secondary | Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant | Number of suspected unexpected serious adverse reactions (SUSARs) per participant from baseline (week 1) to week 24 is presented. SUSAR is a serious adverse event which is unexpected and regarded as possibly or probably related to the trial product. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period. | Full analysis set (FAS) included all participants exposed to the study product. | Posted | Number | Events | From baseline (week 1) to week 24 |
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| Secondary | Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment | Change from baseline in heart rate (pulse) after 24 weeks of treatment is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit. | Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline (week 1), week 24 |
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| 0 |
| 104 |
| 1 |
| 104 |
| 18 |
| 104 |
| Nausea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property
| D004700 | Endocrine System Diseases |