Clinical trial NCT03353350: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Official title: A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2017-11-27
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.

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 \<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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in Glycated Hemoglobin (HbA1c) (%)
timeFrame: Baseline to Week 30
Secondary outcomes:
measure: Change in HbA1c (%)
timeFrame: Baseline to Week 56
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 30
measure: HbA1c <7%
timeFrame: Week 30
measure: Change in Body Weight at Week 30
timeFrame: Baseline to Week 30
measure: Change in Body Weight at Week 56
timeFrame: Baseline to Week 56
measure: Hypoglycemic Participants
timeFrame: Baseline to Week 56
measure: Hypoglycemic Events
timeFrame: Baseline to Week 56
measure: Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline to Week 56
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 8400004
state: Alabama
city: Glendale
country: United States
facility: Investigational Site Number 8400005
state: Arizona
city: Canoga Park
country: United States
facility: Investigational Site Number 8400003
state: California
city: Chula Vista
country: United States
facility: Investigational Site Number 8400007
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 8400011
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8400009
state: California
city: Pomona
country: United States
facility: Investigational Site Number 8400029
state: California
city: Tarzana
country: United States
facility: Investigational Site Number 8400024
state: California
city: Van Nuys
country: United States
facility: Investigational Site Number 8400026
state: California
city: DeLand
country: United States
facility: Investigational Site Number 8400010
state: Florida
city: Hialeah
country: United States
facility: Investigational Site Number 8400006
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site Number 8400032
state: Florida
city: Lawrenceville
country: United States
facility: Investigational Site Number 8400025
state: Georgia
city: Chicago
country: United States
facility: Investigational Site Number 8400034
state: Illinois
city: Kansas City
country: United States
facility: Investigational Site Number 8400033
state: Missouri
city: Lincoln
country: United States
facility: Investigational Site Number 8400018
state: Nebraska
city: Las Vegas
country: United States
facility: Investigational Site Number 8400062
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 8400021
state: Nevada
city: Bridgeton
country: United States
facility: Investigational Site Number 8400001
state: New Jersey
city: Burlington
country: United States
facility: Investigational Site Number 8400028
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 8400031
state: North Carolina
city: Maumee
country: United States
facility: Investigational Site Number 8400013
state: Ohio
city: Hatboro
country: United States
facility: Investigational Site Number 8400008
state: Pennsylvania
city: Carrollton
country: United States
facility: Investigational Site Number 8400017
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 8400030
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 8400015
state: Texas
city: Plano
country: United States
facility: Investigational Site Number 8400019
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8400020
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8400016
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8400027
state: Texas
city: Schertz
country: United States
facility: Investigational Site Number 8400023
state: Texas
city: Holladay
country: United States
facility: Investigational Site Number 8400002
state: Utah
city: Berlin
country: Germany
facility: Investigational Site Number 2760005
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 2760003
city: Leipzig
country: Germany
facility: Investigational Site Number 2760001
city: Gdansk
country: Poland
facility: Investigational Site Number 6160005
city: Gdynia
country: Poland
facility: Investigational Site Number 6160004
city: Katowice
country: Poland
facility: Investigational Site Number 6160007
city: Krakow
country: Poland
facility: Investigational Site Number 6160002
city: Poznan
country: Poland
facility: Investigational Site Number 6160006
city: Warszawa
country: Poland
facility: Investigational Site Number 6160003
city: Wroclaw
country: Poland
facility: Investigational Site Number 6160001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040003
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040002
city: Vinnitsa
country: Ukraine
facility: Investigational Site Number 8040004
city: Birmingham
country: United Kingdom
facility: Investigational Site Number 8260005
city: Cardiff
country: United Kingdom
facility: Investigational Site Number 8260004
city: Chorley
country: United Kingdom
facility: Investigational Site Number 8260007
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 8260008
city: Hexham
country: United Kingdom
facility: Investigational Site Number 8260001
city: Liverpool
country: United Kingdom
facility: Investigational Site Number 8260003
city: Manchester
country: United Kingdom
facility: Investigational Site Number 8260006
city: Reading
country: United Kingdom
facility: Investigational Site Number 8260002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.