Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002956-10 | EudraCT Number | ||
| U1111-1205-3150 | Other Identifier | UTN |
Not provided
Not provided
Sponsor decision to cancel TRIAL, not related to safety concern.
Not provided
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| Name | Class |
|---|---|
| Hanmi Pharmaceutical Company Limited | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Primary Objective:
To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
Secondary Objectives:
Study duration per participant was approximately 65 weeks including an up to 3-week Screening Period, a 56-week Treatment Period and a 6-week safety Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efpeglenatide 4 mg | Experimental | Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration. |
|
| Efpeglenatide 6 mg | Experimental | Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration. |
|
| Dulaglutide 1.5 mg | Active Comparator | Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efpeglenatide | Drug | Pharmaceutical form: solution for injection; Route of administration: SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 56 in HbA1c | Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method. | Baseline to Week 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 56 in Body Weight | Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method. | Baseline to Week 56 |
| Number of Participants With HbA1c < 7.0 % |
Not provided
Inclusion criteria:
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 8400038 | Birmingham | Alabama | 35211 | United States | ||
| Investigational Site Number 8400035 |
No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.
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A total of 908 participants were randomized in 1:1:1 ratio to either efpeglenatide 4 milligram (mg), efpeglenatide 6 mg, or dulaglutide 1.5 mg treatment arms, stratified by screening glycated hemoglobin (HbA1c) values (less than [<]8%, greater than or equal to [>=]8 percent [%]) and by body mass index (BMI) (<30 kg/m^2 and >=30 kg/m^2) on Day 1.
The study was conducted at 45 active sites in 4 countries. A total of 1608 participants were screened between 26 September 2018 and 17 December 2019, out of which 700 were screen failures. Screen failures were mainly due to inclusion criteria not met.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Efpeglenatide 4 mg | Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration. |
| FG001 | Efpeglenatide 6 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2019 | Sep 16, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
The study was open-label for the tested versus comparator drug and double blind for the doses.
Not provided
| Dulaglutide | Drug | Pharmaceutical form: solution for injection; Route of administration: SC |
|
|
| Background therapy Metformin | Drug | Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study. |
|
Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders. |
| Week 56 |
| Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG) | Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method. | Baseline to Week 56 |
| Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia) | Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 milligrams per deciliter (mg/dL) (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. | Baseline up to Week 56 |
| Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year | Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. | Baseline up to Week 56 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Investigational Site Number 8400005 | Glendale | Arizona | 85306 | United States |
| Investigational Site Number 8400054 | Peoria | Arizona | 85381 | United States |
| Investigational Site Number 8400057 | Huntington Park | California | 90255 | United States |
| Investigational Site Number 8400009 | Los Angeles | California | 90057 | United States |
| Investigational Site Number 8400007 | San Diego | California | 92120 | United States |
| Investigational Site Number 8400045 | Spring Valley | California | 91978 | United States |
| Investigational Site Number 8400040 | Tustin | California | 92780 | United States |
| Investigational Site Number 8400026 | Van Nuys | California | 91405 | United States |
| Investigational Site Number 8400050 | Waterbury | Connecticut | 06708 | United States |
| Investigational Site Number 8400055 | Orlando | Florida | 32825 | United States |
| Investigational Site Number 8400041 | Pembroke Pines | Florida | 33026 | United States |
| Investigational Site Number 8400025 | Lawrenceville | Georgia | 30044 | United States |
| Investigational Site Number 8400060 | Meridian | Idaho | 83642 | United States |
| Investigational Site Number 8400059 | Skokie | Illinois | 60077 | United States |
| Investigational Site Number 8400044 | Lexington | Kentucky | 40503 | United States |
| Investigational Site Number 8400061 | Boston | Massachusetts | 02115 | United States |
| Investigational Site Number 8400001 | Bridgeton | New Jersey | 08302 | United States |
| Investigational Site Number 8400039 | New Windsor | New York | 12553 | United States |
| Investigational Site Number 8400028 | Burlington | North Carolina | 27215 | United States |
| Investigational Site Number 8400036 | Morehead City | North Carolina | 28557 | United States |
| Investigational Site Number 8400013 | Maumee | Ohio | 43537 | United States |
| Investigational Site Number 8400014 | Goose Creek | South Carolina | 29445 | United States |
| Investigational Site Number 8400030 | Dallas | Texas | 75230 | United States |
| Investigational Site Number 8400020 | San Antonio | Texas | 78218 | United States |
| Investigational Site Number 8400043 | San Antonio | Texas | 78229 | United States |
| Investigational Site Number 8400053 | San Antonio | Texas | 78258 | United States |
| Investigational Site Number 8400037 | Layton | Utah | 84041 | United States |
| Investigational Site Number 8400049 | Manassas | Virginia | 20110 | United States |
| Investigational Site Number 3480004 | Budapest | 1036 | Hungary |
| Investigational Site Number 3480003 | Debrecen | 4025 | Hungary |
| Investigational Site Number 3480001 | Gyula | 5700 | Hungary |
| Investigational Site Number 3480005 | Hatvan | 3000 | Hungary |
| Investigational Site Number 3480002 | Nyíregyháza | 4400 | Hungary |
| Investigational Site Number 6160008 | Gdansk | 80-382 | Poland |
| Investigational Site Number 6160004 | Gdynia | 81-537 | Poland |
| Investigational Site Number 6160010 | Katowice | 40-040 | Poland |
| Investigational Site Number 6160009 | Poznan | 60-702 | Poland |
| Investigational Site Number 6160003 | Warsaw | 01-192 | Poland |
| Investigational Site Number 6160001 | Wroclaw | 50-381 | Poland |
| Investigational Site Number 8040003 | Kyiv | 02002 | Ukraine |
| Investigational Site Number 8040001 | Kyiv | 03037 | Ukraine |
| Investigational Site Number 8040002 | Kyiv | 03049 | Ukraine |
| Investigational Site Number 8040004 | Vinnytsia | 21050 | Ukraine |
Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration. |
| FG002 | Dulaglutide 1.5 mg | Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration. |
| Treated |
|
| Safety Population | Participants who received at least 1 dose or part of a dose of the Investigational Medicinal Product (IMP), analyzed according to the treatment actually received. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants, analyzed according to the treatment group allocated by randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Efpeglenatide 4 mg | Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration. |
| BG001 | Efpeglenatide 6 mg | Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration. |
| BG002 | Dulaglutide 1.5 mg | Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration. |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
| |||||||||||||||
| Baseline Glycated Hemoglobin (HbA1c %) | Mean | Standard Deviation | percentage of HbA1c |
|
| 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 | Change From Baseline to Week 56 in HbA1c | Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method. | Analysis was performed on modified intent-to-treat (mITT) population which included participants who completed study treatment; or who discontinued study treatment and completed/discontinued study before early termination; or who discontinued treatment before early termination and discontinued study due to early termination; or who discontinued treatment due to early termination within 30 days of target Week 56 visit. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline to Week 56 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 56 in Body Weight | Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method. | Analysis was performed on mITT population. | Posted | Least Squares Mean | Standard Error | kilogram | Baseline to Week 56 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HbA1c < 7.0 % | Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders. | Analysis was performed on mITT population. | Posted | Count of Participants | Participants | Week 56 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG) | Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method. | Analysis was performed on mITT population. | Posted | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | Baseline to Week 56 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia) | Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 milligrams per deciliter (mg/dL) (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. | Analysis was performed on safety population. | Posted | Count of Participants | Participants | Baseline up to Week 56 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year | Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. | Analysis was performed on safety population. | Posted | Number | events per participant-year | Baseline up to Week 56 |
|
All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60).
TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
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 | Efpeglenatide 4 mg | Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration. | 0 | 313 | 20 | 313 | 202 | 313 |
| EG001 | Efpeglenatide 6 mg | Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration. | 0 | 292 | 23 | 292 | 180 | 292 |
| EG002 | Dulaglutide 1.5 mg | Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration. | 1 | 302 | 20 | 302 | 178 | 302 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Benign Salivary Gland Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Colon Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Meningioma Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Papillary Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Renal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal Meningioma Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vascular Encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sinus Node Dysfunction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertensive Urgency | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diverticulum Intestinal Haemorrhagic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Omental Necrosis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis Chronic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subcapsular Renal Haematoma | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Vascular Graft Occlusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, model-based efficacy analyses were performed in the mITT population instead of the ITT population originally planned and data was carefully considered given that the study was terminated early.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2020 | Sep 16, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709212 | efpeglenatide |
| C555680 | dulaglutide |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Not reported |
|
| A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate. | LS Mean Difference | -0.08 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -0.25 | 0.09 | Non-Inferiority | Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was <=0.3%. |
| ANCOVA | 0.7064 | Threshold for significance at the level of 0.05. | Superiority |
| ANCOVA | 0.3427 | Threshold for significance at the level of 0.05. | Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
|
|
|
|