Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea

NCT ID: NCT03770728

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-12-27

Brief 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 type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU).

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.

Detailed Description

Study duration per participant was approximately 39 weeks including an up to 3-week Screening Period, a 30-week Treatment Period, and a 6-week safety Follow-up Period.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Background therapy: Metformin alone or in combination with SU

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.

Efpeglenatide 2 mg

Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.

Group Type: EXPERIMENTAL

Efpeglenatide SAR439977

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Background therapy: Metformin alone or in combination with SU

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.

Efpeglenatide 4 mg

Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.

Group Type: EXPERIMENTAL

Efpeglenatide SAR439977

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Background therapy: Metformin alone or in combination with SU

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.

Efpeglenatide 6 mg

Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.

Group Type: EXPERIMENTAL

Efpeglenatide SAR439977

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Background therapy: Metformin alone or in combination with SU

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.

Interventions

Efpeglenatide SAR439977

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

Placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

Background therapy: Metformin alone or in combination with SU

Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.

Intervention Type: DRUG

Eligibility Criteria

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 metformin alone or in combination with SU, for at least 3 months prior to screening.
• Glycated hemoglobin between 7.0% 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 or history of surgery affecting gastric emptying.
• 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 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg at randomization.
• Severe renal disease as defined by estimated glomerular filtration rate (eGFR) of <30 milliliters per minute per 1.73 square meter.
• Laboratory findings at the screening visit:

• Alanine aminotransferase or aspartate aminotransferase >3*upper limit of the normal (ULN) or total bilirubin >1.5*ULN (except in case of documented Gilbert's syndrome);
• Amylase and/or lipase: >3*ULN laboratory range;
• Calcitonin >=5.9 picomoles per liter (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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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 8400042

Mesa, Arizona, United States

Investigational Site Number 8400051

Phoenix, Arizona, United States

Investigational Site Number 8400056

Tucson, Arizona, United States

Investigational Site Number 8400057

Huntington Park, 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 8400047

Colorado Springs, Colorado, United States

Investigational Site Number 8400046

Coral Gables, Florida, United States

Investigational Site Number 8400041

Pembroke Pines, Florida, United States

Investigational Site Number 8400025

Lawrenceville, Georgia, 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 8400048

Oklahoma City, Oklahoma, United States

Investigational Site Number 8400030

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 1560042

Beijing, , China

Investigational Site Number 1560053

Hangzhou, , China

Investigational Site Number 1560051

Hefei, , China

Investigational Site Number 1560011

Hunan, , China

Investigational Site Number 1560025

Meihekou, , China

Investigational Site Number 1560055

Nanchang, , China

Investigational Site Number 1560024

Nanjing, , China

Investigational Site Number 1560020

Pingxiang, , China

Investigational Site Number 1560031

Shandong, , China

Investigational Site Number 1560030

Shandong, , China

Investigational Site Number 1560012

Shanghai, , China

Investigational Site Number 1560013

Shanghai, , China

Investigational Site Number 1560004

Shanghai, , China

Investigational Site Number 1560022

Shanghai, , China

Investigational Site Number 1560041

Tianjin, , China

Investigational Site Number 1560010

Wenzhou, , China

Investigational Site Number 1560052

Wuhu, , China

Investigational Site Number 1560034

Wuxi, , China

Investigational Site Number 1560026

Xuzhou, , China

Investigational Site Number 1560044

Yichun, , China

Investigational Site Number 1560003

Zhengzhou, , China

Investigational Site Number 1580006

Kaohsiung City, , Taiwan

Investigational Site Number 1580003

Taichung, , Taiwan

Investigational Site Number 1580002

Taipei, , Taiwan

Countries

United States; China; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1205-1291

Identifier Type: OTHER

Identifier Source: secondary_id

EFC15337

Identifier Type: -

Identifier Source: org_study_id