Clinical trial NCT03770728: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
Official title: A 30-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 Metformin Alone or in Combination With Sulfonylurea
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: 2018-12-10
Enrollment: 312
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 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.

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.

Primary outcomes:
measure: Change From Baseline to Week 30 in HbA1c
timeFrame: Baseline to Week 30
Secondary outcomes:
measure: Number of Participants With HbA1c <7.0%
timeFrame: Week 30
measure: Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 30
measure: Change From Baseline to Week 30 in Body Weight
timeFrame: Baseline to Week 30
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 30
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 30
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: Mesa
country: United States
facility: Investigational Site Number 8400042
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 8400051
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number 8400056
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: 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: Colorado Springs
country: United States
facility: Investigational Site Number 8400047
state: Colorado
city: Coral Gables
country: United States
facility: Investigational Site Number 8400046
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: Lexington
country: United States
facility: Investigational Site Number 8400044
state: Kentucky
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: 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: Oklahoma City
country: United States
facility: Investigational Site Number 8400048
state: Oklahoma
city: Dallas
country: United States
facility: Investigational Site Number 8400030
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8400043
state: Texas
city: Layton
country: United States
facility: Investigational Site Number 8400037
state: Utah
city: Baotou
country: China
facility: Investigational Site Number 1560005
city: Beijing
country: China
facility: Investigational Site Number 1560042
city: Hangzhou
country: China
facility: Investigational Site Number 1560053
city: Hefei
country: China
facility: Investigational Site Number 1560051
city: Hunan
country: China
facility: Investigational Site Number 1560011
city: Meihekou
country: China
facility: Investigational Site Number 1560025
city: Nanchang
country: China
facility: Investigational Site Number 1560055
city: Nanjing
country: China
facility: Investigational Site Number 1560024
city: Pingxiang
country: China
facility: Investigational Site Number 1560020
city: Shandong
country: China
facility: Investigational Site Number 1560031
city: Shandong
country: China
facility: Investigational Site Number 1560030
city: Shanghai
country: China
facility: Investigational Site Number 1560012
city: Shanghai
country: China
facility: Investigational Site Number 1560013
city: Shanghai
country: China
facility: Investigational Site Number 1560004
city: Shanghai
country: China
facility: Investigational Site Number 1560022
city: Tianjin
country: China
facility: Investigational Site Number 1560041
city: Wenzhou
country: China
facility: Investigational Site Number 1560010
city: Wuhu
country: China
facility: Investigational Site Number 1560052
city: Wuxi
country: China
facility: Investigational Site Number 1560034
city: Xuzhou
country: China
facility: Investigational Site Number 1560026
city: Yichun
country: China
facility: Investigational Site Number 1560044
city: Zhengzhou
country: China
facility: Investigational Site Number 1560003
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number 1580006
city: Taichung
country: Taiwan
facility: Investigational Site Number 1580003
city: Taipei
country: Taiwan
facility: Investigational Site Number 1580002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: