Clinical trial NCT03713684: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
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 Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
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: 2018-10-22
Enrollment: 370
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 basal insulin alone or in combination with oral antidiabetic drugs (OADs).

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 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension 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 basal insulin regimen alone or in combination with OADs for at least 6 months prior to screening.
* HbA1c between 7.0 percent (%) 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.
* 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 millimetres of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg at randomization.
* End-stage renal disease as defined by estimated glomerular filtration rate (by Modification of Diet in Renal Disease) of less than 15 mL/min/1.73 m\^2.
* Laboratory findings at the screening Visit:

  * Alanine aminotransferase or aspartate aminotransferase \>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 \[pg/mL\]).
* 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 were 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% at Week 30
timeFrame: Week 30
measure: Change From Baseline to Week 56 in HbA1c
timeFrame: Baseline to Week 56
measure: Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 30
measure: Change From Baseline to Week 30 and Week 56 in Body Weight
timeFrame: Baseline to Week 30 and Week 56
measure: Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and 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: Huntington Park
country: United States
facility: Investigational Site Number 8400057
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 8400058
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: Van Nuys
country: United States
facility: Investigational Site Number 8400026
state: California
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: West Des Moines
country: United States
facility: Investigational Site Number 8400052
state: Iowa
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: Dallas
country: United States
facility: Investigational Site Number 8400030
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 8400063
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 1560017
city: Changsha
country: China
facility: Investigational Site Number 1560006
city: Chengdu
country: China
facility: Investigational Site Number 1560001
city: Shanghai
country: China
facility: Investigational Site Number 1560004
city: Shanghai
country: China
facility: Investigational Site Number 1560036
city: Shanghai
country: China
facility: Investigational Site Number 1560012
city: Shanghai
country: China
facility: Investigational Site Number 1560013
city: Zhengzhou
country: China
facility: Investigational Site Number 1560003
city: Busan
country: Korea, Republic of
facility: Investigational Site Number 4100009
city: Daejeon
country: Korea, Republic of
facility: Investigational Site Number 4100001
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number 4100016
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number 4100010
city: Gyeonggi-do
country: Korea, Republic of
facility: Investigational Site Number 4100013
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 4100015
city: Jeonju
country: Korea, Republic of
facility: Investigational Site Number 4100014
city: Seongnam-Si
country: Korea, Republic of
facility: Investigational Site Number 4100007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100008
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100002
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100005
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100004
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100011
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100006
city: Suwon
country: Korea, Republic of
facility: Investigational Site Number 4100012
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: