Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

NCT03353350 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: EFC148222016-001857-42U1111-1182-1806
• Study Type: interventional
• Target: 406
• Locations: 5 countries
• Sites: 54

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 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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Hemoglobin (HbA1c) (%)

  Change from Baseline to Week 30 in HbA1c

  Baseline to Week 30

Secondary Outcomes (8)

• Change in HbA1c (%)

  Baseline to Week 56

• Change in Fasting Plasma Glucose (FPG)

  Baseline to Week 30

• HbA1c <7%

  Week 30

• Change in Body Weight at Week 30

  Baseline to Week 30

• Change in Body Weight at Week 56

  Baseline to Week 56

Study Arms (4)

Efpeglenatide 2mg

EXPERIMENTAL

Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks

Drug: efpeglenatide (SAR439977)

Efpeglenatide 4 mg

EXPERIMENTAL

Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)

Drug: efpeglenatide (SAR439977)

Efpeglenatide 6 mg

EXPERIMENTAL

Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)

Drug: efpeglenatide (SAR439977)

Placebo

PLACEBO COMPARATOR

Matching placebo (Prefilled syringe) administered once weekly for 56 weeks

Drug: placebo

Interventions

efpeglenatide (SAR439977) DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Efpeglenatide 2mg; Efpeglenatide 4 mg; Efpeglenatide 6 mg

placebo DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \<15 mL/min/1.73 m2.
• Laboratory findings at the Screening Visit:
• Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) \>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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead
• Sanofi: collaborator

Study Sites (54)

Investigational Site Number 8400004

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 8400005

Glendale, Arizona, 85306, United States

Location

Investigational Site Number 8400003

Canoga Park, California, 91303, United States

Location

Investigational Site Number 8400007

Chula Vista, California, 91911, United States

Location

Investigational Site Number 8400011

La Mesa, California, 91942, United States

Location

Investigational Site Number 8400009

Los Angeles, California, 90057, United States

Location

Investigational Site Number 8400029

Pomona, California, 91767, United States

Location

Investigational Site Number 8400024

Tarzana, California, 91356, United States

Location

Investigational Site Number 8400026

Van Nuys, California, 91405, United States

Location

Investigational Site Number 8400010

DeLand, Florida, 32720, United States

Location

Investigational Site Number 8400006

Hialeah, Florida, 33012, United States

Location

Investigational Site Number 8400032

West Palm Beach, Florida, 33409, United States

Location

Investigational Site Number 8400025

Lawrenceville, Georgia, 30044, United States

Location

Investigational Site Number 8400034

Chicago, Illinois, 60612, United States

Location

Investigational Site Number 8400033

Kansas City, Missouri, 64128, United States

Location

Investigational Site Number 8400018

Lincoln, Nebraska, 68503, United States

Location

Investigational Site Number 8400062

Las Vegas, Nevada, 89106, United States

Location

Investigational Site Number 8400021

Las Vegas, Nevada, 89109, United States

Location

Investigational Site Number 8400001

Bridgeton, New Jersey, 08302, United States

Location

Investigational Site Number 8400028

Burlington, North Carolina, 27215, United States

Location

Investigational Site Number 8400031

Wilmington, North Carolina, 28401, United States

Location

Investigational Site Number 8400013

Maumee, Ohio, 43537, United States

Location

Investigational Site Number 8400008

Hatboro, Pennsylvania, 19040, United States

Location

Investigational Site Number 8400017

Carrollton, Texas, 75010, United States

Location

Investigational Site Number 8400030

Dallas, Texas, 75230, United States

Location

Investigational Site Number 8400015

Houston, Texas, 77074, United States

Location

Investigational Site Number 8400019

Plano, Texas, 75024, United States

Location

Investigational Site Number 8400020

San Antonio, Texas, 78218, United States

Location

Investigational Site Number 8400016

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 8400027

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 8400023

Schertz, Texas, 78154, United States

Location

Investigational Site Number 8400002

Holladay, Utah, 84117-7054, United States

Location

Investigational Site Number 2760005

Berlin, 12627, Germany

Location

Investigational Site Number 2760003

Frankfurt am Main, 60313, Germany

Location

Investigational Site Number 2760001

Leipzig, 04103, Germany

Location

Investigational Site Number 6160005

Gdansk, 80-382, Poland

Location

Investigational Site Number 6160004

Gdynia, 81-537, Poland

Location

Investigational Site Number 6160007

Katowice, 40-040, Poland

Location

Investigational Site Number 6160002

Krakow, 31-501, Poland

Location

Investigational Site Number 6160006

Poznan, 60-702, Poland

Location

Investigational Site Number 6160003

Warsaw, 01-192, Poland

Location

Investigational Site Number 6160001

Wroclaw, 50-381, Poland

Location

Investigational Site Number 8040003

Kyiv, 02002, Ukraine

Location

Investigational Site Number 8040001

Kyiv, 03037, Ukraine

Location

Investigational Site Number 8040002

Kyiv, 03049, Ukraine

Location

Investigational Site Number 8040004

Vinnitsa, 21009, Ukraine

Location

Investigational Site Number 8260005

Birmingham, B15 2SQ, United Kingdom

Location

Investigational Site Number 8260004

Cardiff, CF15 9SS, United Kingdom

Location

Investigational Site Number 8260007

Chorley, PR7 7NA, United Kingdom

Location

Investigational Site Number 8260008

Glasgow, G20 0SP, United Kingdom

Location

Investigational Site Number 8260001

Hexham, NE46 1QJ, United Kingdom

Location

Investigational Site Number 8260003

Liverpool, L22 0LG, United Kingdom

Location

Investigational Site Number 8260006

Manchester, M15 6SX, United Kingdom

Location

Investigational Site Number 8260002

Reading, RG2 0TG, United Kingdom

Location

Related Publications (1)

• Frias JP, Choi J, Rosenstock J, Popescu L, Niemoeller E, Muehlen-Bartmer I, Baek S. Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Diabetes Care. 2022 Jul 7;45(7):1592-1600. doi: 10.2337/dc21-2656.

  PMID: 35671039 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

efpeglenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Sujin Jung
• Organization: Hanmi Pharmaceutical Co., Ltd.

sujin.jung@hanmi.co.kr

+82-2-410-0473

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: December 5, 2017
• Primary Completion: January 29, 2020
• Study Completion: September 7, 2020
• Last Updated: January 18, 2022
• Results First Posted: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); UA (4); GB (8); US (32); PL (7)