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Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Phase 3 trial testing Efpeglenatide in Type 2 Diabetes Mellitus in 908 participants. Terminated before completion.
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 908 |
| Start date | 26 September 2018 |
| Primary completion | 13 October 2020 |
| Estimated completion | 17 November 2020 |
| Sites | 45 locations across Ukraine, Poland, United States, Hungary |
Sanofi — full company profile →
18 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Efpeglenatide 4 mg | -1.12 | ± 0.06 |
| Efpeglenatide 6 mg | -1.17 | ± 0.06 |
| Dulaglutide 1.5 mg | -1.09 | ± 0.06 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Efpeglenatide 4 mg | -2.87 | ± 0.64 |
| Efpeglenatide 6 mg | -3.04 | ± 0.67 |
| Dulaglutide 1.5 mg | -2.81 | ± 0.66 |
Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.
| Group | Value | 95% CI |
|---|---|---|
| Efpeglenatide 4 mg | 155 | |
| Efpeglenatide 6 mg | 157 | |
| Dulaglutide 1.5 mg | 150 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Efpeglenatide 4 mg | -1.81 | ± 0.15 |
| Efpeglenatide 6 mg | -1.57 | ± 0.15 |
| Dulaglutide 1.5 mg | -1.71 | ± 0.15 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Efpeglenatide 4 mg | 3 | |
| Efpeglenatide 6 mg | 1 | |
| Dulaglutide 1.5 mg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Efpeglenatide 4 mg | 0 | |
| Efpeglenatide 6 mg | 0 | |
| Dulaglutide 1.5 mg | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Efpeglenatide 4 mg | 0.01 | |
| Efpeglenatide 6 mg | 0.01 | |
| Dulaglutide 1.5 mg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Efpeglenatide 4 mg | 0 | |
| Efpeglenatide 6 mg | 0 | |
| Dulaglutide 1.5 mg | 0 |
Time frame: 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).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Efpeglenatide 4 mg | Efpeglenatide 6 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | — | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — | — |
| Atrioventricular Block Complete | Cardiac disorders | — | — | — |
| Coronary Artery Disease | Cardiac disorders | — | — | — |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — |
| Covid-19 Pneumonia | Infections and infestations | — | — | — |
| Cholecystitis Infective | Infections and infestations | — | — | — |
| Diverticulitis | Infections and infestations | — | — | — |
| Escherichia Urinary Tract Infection | Infections and infestations | — | — | — |
| Gangrene | Infections and infestations | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Sepsis | Infections and infestations | — | — | — |
| Sialoadenitis | Infections and infestations | — | — | — |
| Staphylococcal Infection | Infections and infestations | — | — | — |
| Benign Salivary Gland Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Colon Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Meningioma Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Papillary Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Renal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Spinal Meningioma Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — |
| Reaction | System | Efpeglenatide 4 mg | Efpeglenatide 6 mg | Dulaglutide 1.5 mg |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Decreased Appetite | Metabolism and nutrition disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — |
| Lipase Increased | Investigations | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Abdominal Pain Upper | Gastrointestinal disorders | — | — | — |
| Upper Respiratory Tract Infection | Infections and infestations | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
Most-reported serious reactions: Acute Myocardial Infarction, Atrial Fibrillation, Atrioventricular Block Complete, Coronary Artery Disease, Pulmonary Embolism, Cholelithiasis, Covid-19 Pneumonia, Cholecystitis Infective.
Data from ClinicalTrials.gov NCT03684642 adverse events section.
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: * To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control. * To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight. * To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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