Current partner codePEPTIDESDE
NCT03684642·Phase 3·INTERVENTIONAL

Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Status

Terminated

Phase

Phase 3

Enrollment

908

Locations

45

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

Efpeglenatide

Pharmaceutical form: solution for injection; Route of administration: SC

DRUG

Dulaglutide

Pharmaceutical form: solution for injection; Route of administration: SC

DRUG

Background therapy Metformin

Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.

Timeline

From registration to results.

  1. First posted

    Sep 26, 2018

  2. Study start

    Sep 26, 2018

  3. Primary completion

    Oct 13, 2020

  4. Study completion

    Nov 17, 2020

  5. Results posted

    Nov 1, 2021

  6. Registry updated

    Nov 1, 2021

Outcomes

What the study measures.

Primary outcomes

Change From Baseline to Week 56 in HbA1c

Time frame · Baseline to Week 56

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.

Secondary outcomes

Change From Baseline to Week 56 in Body Weight

Time frame · Baseline to Week 56

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.

Number of Participants With HbA1c < 7.0 %

Time frame · Week 56

Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.

Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)

Time frame · Baseline to Week 56

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.

Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)

Time frame · Baseline up to Week 56

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.

Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year

Time frame · Baseline up to Week 56

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion criteria: * Participant must be greater than or equal to (\>=) 18 years of age at the time of signing the informed consent. * Participants with T2DM. * Diabetes diagnosed at least 1 year before screening. * Participants on stable dose of at least 1500 milligram per day (mg/day) of metformin, or tolerated maximum dose, or as per country regulation if less, for at least 3 months prior to screening. * HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening. Exclusion criteria: * Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery. * Clinically relevant history of gastrointestinal (GI) disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease requiring medical treatment within 6 months prior to screening or history of surgery affecting gastric emptying. * History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy. * Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes). * Body weight change of greater than or equal to (\>=) 5 kilogram within the last 3 months prior to screening. * Systolic blood pressure greater than (\>)180 millimeter of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg at randomization. * Severe renal disease as defined by estimated glomerular filtration rate (eGFR), by Modification of Diet in Renal Disease (MDRD)\] of less than (\<)30 mL/min/1.73 m\^2. * Laboratory findings at the screening visit: * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 \* upper limit of normal (ULN) or total bilirubin \>1.5 \* ULN (except in case of documented Gilbert's syndrome); * Amylase and/or lipase: \>3 \* ULN; * Calcitonin \>=5.9 picomoles per liter (pmol/L) (20 picograms per milliliter). * Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to screening, or planned during study period. * Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women. * Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control or who are unwilling to be tested for pregnancy during the study period and for at least 5 weeks after the last dose of study intervention. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study locations

45 registered sites.

Hungary · Poland · Ukraine · United States. Showing up to 24 locations stored in the fast local snapshot.

Investigational Site Number 8400038

Birmingham, Alabama, United States

Investigational Site Number 8400035

Chandler, Arizona, United States

Investigational Site Number 8400005

Glendale, Arizona, United States

Investigational Site Number 8400054

Peoria, Arizona, United States

Investigational Site Number 8400057

Huntington Park, California, United States

Investigational Site Number 8400009

Los Angeles, California, United States

Investigational Site Number 8400007

San Diego, California, United States

Investigational Site Number 8400045

Spring Valley, California, United States

Investigational Site Number 8400040

Tustin, California, United States

Investigational Site Number 8400026

Van Nuys, California, United States

Investigational Site Number 8400050

Waterbury, Connecticut, United States

Investigational Site Number 8400055

Orlando, Florida, United States

Investigational Site Number 8400041

Pembroke Pines, Florida, United States

Investigational Site Number 8400025

Lawrenceville, Georgia, United States

Investigational Site Number 8400060

Meridian, Idaho, United States

Investigational Site Number 8400059

Skokie, Illinois, United States

Investigational Site Number 8400044

Lexington, Kentucky, United States

Investigational Site Number 8400061

Boston, Massachusetts, United States

Investigational Site Number 8400001

Bridgeton, New Jersey, United States

Investigational Site Number 8400039

New Windsor, New York, United States

Investigational Site Number 8400028

Burlington, North Carolina, United States

Investigational Site Number 8400036

Morehead City, North Carolina, United States

Investigational Site Number 8400013

Maumee, Ohio, United States

Investigational Site Number 8400014

Goose Creek, South Carolina, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.