Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea

Type 2 Diabetes Mellitus Clinical Trial

— AMPLITUDE-S  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03770728
• Other study ID #: EFC15337
• Secondary ID: U1111-1205-1291
• Status: Terminated
• Phase: Phase 3
• Start date: August 1, 2019
• Est. completion date: December 27, 2020

Study information

• Verified date: November 2021
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 312
• Est. completion date: December 27, 2020
• Est. primary completion date: November 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous
• Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
• Background therapy: Metformin alone or in combination with SU
Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.

Locations

Country	Name	City	State
China	Investigational Site Number 1560005	Baotou
China	Investigational Site Number 1560042	Beijing
China	Investigational Site Number 1560053	Hangzhou
China	Investigational Site Number 1560051	Hefei
China	Investigational Site Number 1560011	Hunan
China	Investigational Site Number 1560025	Meihekou
China	Investigational Site Number 1560055	Nanchang
China	Investigational Site Number 1560024	Nanjing
China	Investigational Site Number 1560020	Pingxiang
China	Investigational Site Number 1560030	Shandong
China	Investigational Site Number 1560031	Shandong
China	Investigational Site Number 1560004	Shanghai
China	Investigational Site Number 1560012	Shanghai
China	Investigational Site Number 1560013	Shanghai
China	Investigational Site Number 1560022	Shanghai
China	Investigational Site Number 1560041	Tianjin
China	Investigational Site Number 1560010	Wenzhou
China	Investigational Site Number 1560052	Wuhu
China	Investigational Site Number 1560034	Wuxi
China	Investigational Site Number 1560026	Xuzhou
China	Investigational Site Number 1560044	Yichun
China	Investigational Site Number 1560003	Zhengzhou
Taiwan	Investigational Site Number 1580006	Kaohsiung
Taiwan	Investigational Site Number 1580003	Taichung
Taiwan	Investigational Site Number 1580002	Taipei
United States	Investigational Site Number 8400038	Birmingham	Alabama
United States	Investigational Site Number 8400001	Bridgeton	New Jersey
United States	Investigational Site Number 8400035	Chandler	Arizona
United States	Investigational Site Number 8400047	Colorado Springs	Colorado
United States	Investigational Site Number 8400046	Coral Gables	Florida
United States	Investigational Site Number 8400030	Dallas	Texas
United States	Investigational Site Number 8400005	Glendale	Arizona
United States	Investigational Site Number 8400057	Huntington Park	California
United States	Investigational Site Number 8400025	Lawrenceville	Georgia
United States	Investigational Site Number 8400037	Layton	Utah
United States	Investigational Site Number 8400044	Lexington	Kentucky
United States	Investigational Site Number 8400009	Los Angeles	California
United States	Investigational Site Number 8400013	Maumee	Ohio
United States	Investigational Site Number 8400042	Mesa	Arizona
United States	Investigational Site Number 8400036	Morehead City	North Carolina
United States	Investigational Site Number 8400039	New Windsor	New York
United States	Investigational Site Number 8400048	Oklahoma City	Oklahoma
United States	Investigational Site Number 8400041	Pembroke Pines	Florida
United States	Investigational Site Number 8400051	Phoenix	Arizona
United States	Investigational Site Number 8400043	San Antonio	Texas
United States	Investigational Site Number 8400045	Spring Valley	California
United States	Investigational Site Number 8400056	Tucson	Arizona
United States	Investigational Site Number 8400040	Tustin	California

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Hanmi Pharmaceutical Company Limited

Countries where clinical trial is conducted

United States,  China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 30 in HbA1c	This analysis included all Week 30 assessment values available.	Baseline to Week 30
Secondary	Number of Participants With HbA1c <7.0%	Participants who had no available assessment for HbA1c <7% at Week 30 were considered as non-responders.	Week 30
Secondary	Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)	This analysis included all Week 30 assessment values available.	Baseline to Week 30
Secondary	Change From Baseline to Week 30 in Body Weight	This analysis included all Week 30 assessment values available.	Baseline to Week 30
Secondary	Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)	Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 milligrams per deciliter (mg/dL) (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.	Baseline up to Week 30
Secondary	Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year	Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.	Baseline up to Week 30