Phase 3
Completed N=406
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Source: ClinicalTrials.gov NCT03353350 ↗Enrolled (actual)
406
Serious AEs
7.9%
Results posted
Jan 2022
Primary outcomePrimary: Change in Glycated Hemoglobin (HbA1c) (%) — -0.46; -1.14; -1.48; -1.59 HbA1c (%)
◆ Published Evidence
Established
36citations · ~9 / year
Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial.
Summary
Primary Objective:
To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise.
Secondary Objectives:
* To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control
* To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight
* To evaluate the safety of once-weekly injection of efpeglenatide
Linked Publications
-
Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycated Hemoglobin (HbA1c) (%) |
-0.46; -1.14; -1.48; -1.59 | — |
| SECONDARY Change in HbA1c (%) |
-0.52; -1.18; -1.51; -1.51 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
8.59; -0.87; 6.84; 6.55 | — |
| SECONDARY HbA1c <7% |
26; 60; 66; 76 | — |
| SECONDARY Change in Body Weight at Week 30 |
-1.35; -1.01; -3.34; -3.19 | — |
| SECONDARY Change in Body Weight at Week 56 |
-1.26; -0.94; -3.24; -1.82 | — |
| SECONDARY Hypoglycemic Participants |
2; 10; 14; 14 | — |
| SECONDARY Hypoglycemic Events |
2; 10; 14; 14 | — |
| SECONDARY Treatment Emergent Adverse Events (TEAEs) |
79; 80; 79; 83 | — |
Eligibility Criteria
Inclusion criteria
- Participants must be at least 18 years of age at the time of signing the informed consent.
- Participants with T2DM, and treated with diet and exercise.
- Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.
Exclusion criteria
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening or history of surgery affecting gastric emptying.
- History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy.
- Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
- Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
- Body weight change of ≥5 kg within the last 3 months prior to Screening.
- Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Randomization.
- End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease [MDRD]) of 3 times the upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case of documented Gilbert's syndrome).
- Amylase and/or lipase: >3 times the ULN laboratory range.
- Calcitonin ≥5.9 pmol/L (20 pg/mL).
- Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
- History of drug or alcohol abuse within 6 months prior to the time of Screening.
- Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
- Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03353350) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.