Clinical trial NCT03684642: Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Official title: A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Hanmi Pharmaceutical Company Limited
First posted: 2018-09-26
Enrollment: 908
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 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.

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.

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 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.

Primary outcomes:
measure: Change From Baseline to Week 56 in HbA1c
timeFrame: Baseline to Week 56
Secondary outcomes:
measure: Change From Baseline to Week 56 in Body Weight
timeFrame: Baseline to Week 56
measure: Number of Participants With HbA1c < 7.0 %
timeFrame: Week 56
measure: Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 56
measure: Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)
timeFrame: Baseline up to Week 56
measure: Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year
timeFrame: Baseline up to Week 56
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 8400038
state: Alabama
city: Chandler
country: United States
facility: Investigational Site Number 8400035
state: Arizona
city: Glendale
country: United States
facility: Investigational Site Number 8400005
state: Arizona
city: Peoria
country: United States
facility: Investigational Site Number 8400054
state: Arizona
city: Huntington Park
country: United States
facility: Investigational Site Number 8400057
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8400009
state: California
city: San Diego
country: United States
facility: Investigational Site Number 8400007
state: California
city: Spring Valley
country: United States
facility: Investigational Site Number 8400045
state: California
city: Tustin
country: United States
facility: Investigational Site Number 8400040
state: California
city: Van Nuys
country: United States
facility: Investigational Site Number 8400026
state: California
city: Waterbury
country: United States
facility: Investigational Site Number 8400050
state: Connecticut
city: Orlando
country: United States
facility: Investigational Site Number 8400055
state: Florida
city: Pembroke Pines
country: United States
facility: Investigational Site Number 8400041
state: Florida
city: Lawrenceville
country: United States
facility: Investigational Site Number 8400025
state: Georgia
city: Meridian
country: United States
facility: Investigational Site Number 8400060
state: Idaho
city: Skokie
country: United States
facility: Investigational Site Number 8400059
state: Illinois
city: Lexington
country: United States
facility: Investigational Site Number 8400044
state: Kentucky
city: Boston
country: United States
facility: Investigational Site Number 8400061
state: Massachusetts
city: Bridgeton
country: United States
facility: Investigational Site Number 8400001
state: New Jersey
city: New Windsor
country: United States
facility: Investigational Site Number 8400039
state: New York
city: Burlington
country: United States
facility: Investigational Site Number 8400028
state: North Carolina
city: Morehead City
country: United States
facility: Investigational Site Number 8400036
state: North Carolina
city: Maumee
country: United States
facility: Investigational Site Number 8400013
state: Ohio
city: Goose Creek
country: United States
facility: Investigational Site Number 8400014
state: South Carolina
city: Dallas
country: United States
facility: Investigational Site Number 8400030
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 8400043
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8400053
state: Texas
city: Layton
country: United States
facility: Investigational Site Number 8400037
state: Utah
city: Manassas
country: United States
facility: Investigational Site Number 8400049
state: Virginia
city: Budapest
country: Hungary
facility: Investigational Site Number 3480004
city: Debrecen
country: Hungary
facility: Investigational Site Number 3480003
city: Gyula
country: Hungary
facility: Investigational Site Number 3480001
city: Hatvan
country: Hungary
facility: Investigational Site Number 3480005
city: Nyíregyháza
country: Hungary
facility: Investigational Site Number 3480002
city: Gdansk
country: Poland
facility: Investigational Site Number 6160008
city: Gdynia
country: Poland
facility: Investigational Site Number 6160004
city: Katowice
country: Poland
facility: Investigational Site Number 6160010
city: Poznan
country: Poland
facility: Investigational Site Number 6160009
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: Vinnytsia
country: Ukraine
facility: Investigational Site Number 8040004
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: