Current partner codePEPTIDESDE
NCT03713684·Phase 3·INTERVENTIONAL

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

Status

Terminated

Phase

Phase 3

Enrollment

370

Locations

47

Results

Posted

Publications

0

Study summary

What the protocol is testing.

Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with basal insulin alone or in combination with oral antidiabetic drugs (OADs). 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.

Full detailed description

Study duration per participant was approximately 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension Period, and a 6-week safety Follow-up Period.

Interventions

Treatment arms and agents.

DRUG

Efpeglenatide SAR439977

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Background therapy

Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription and in accordance with local labeling.

Timeline

From registration to results.

  1. First posted

    Oct 22, 2018

  2. Study start

    Nov 9, 2018

  3. Primary completion

    Nov 20, 2020

  4. Study completion

    Jan 4, 2021

  5. Results posted

    Dec 2, 2021

  6. Registry updated

    Dec 2, 2021

Outcomes

What the study measures.

Primary outcomes

Change From Baseline to Week 30 in HbA1c

Time frame · Baseline to Week 30

Secondary outcomes

Number of Participants With HbA1c <7.0% at Week 30

Time frame · Week 30

Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders.

Change From Baseline to Week 56 in HbA1c

Time frame · Baseline to Week 56

This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.

Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)

Time frame · Baseline to Week 30

Change From Baseline to Week 30 and Week 56 in Body Weight

Time frame · Baseline to Week 30 and Week 56

This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.

Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and 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 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 basal insulin regimen alone or in combination with OADs for at least 6 months prior to screening. * HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening. Exclusion criteria: * History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening. * 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 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. * History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has 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 predispose to MTC (e.g., multiple endocrine neoplasia syndromes). * Body weight change of \>=5 kilograms within the last 3 months prior to screening. * Systolic blood pressure greater than (\>)180 millimetres of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg at randomization. * End-stage renal disease as defined by estimated glomerular filtration rate (by Modification of Diet in Renal Disease) of less than 15 mL/min/1.73 m\^2. * Laboratory findings at the screening Visit: * Alanine aminotransferase or aspartate aminotransferase \>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 \[pg/mL\]). * 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 not willing to use highly effective method(s) of birth control or who were 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

47 registered sites.

China · South Korea · 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 8400057

Huntington Park, California, United States

Investigational Site Number 8400058

La Jolla, California, United States

Investigational Site Number 8400009

Los Angeles, 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 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 8400052

West Des Moines, Iowa, United States

Investigational Site Number 8400044

Lexington, Kentucky, United States

Investigational Site Number 8400001

Bridgeton, New Jersey, United States

Investigational Site Number 8400039

New Windsor, New York, United States

Investigational Site Number 8400036

Morehead City, North Carolina, United States

Investigational Site Number 8400013

Maumee, Ohio, United States

Investigational Site Number 8400030

Dallas, Texas, United States

Investigational Site Number 8400063

Dallas, Texas, United States

Investigational Site Number 8400043

San Antonio, Texas, United States

Investigational Site Number 8400037

Layton, Utah, United States

Investigational Site Number 1560005

Baotou, China

Investigational Site Number 1560017

Beijing, China

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.