Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Type 2 Diabetes Mellitus Clinical Trial

— AMPLITUDE-M  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353350
• Other study ID #: EFC14822
• Secondary ID: 2016-001857-42U1
• Status: Completed
• Phase: Phase 3
• Start date: December 5, 2017
• Est. completion date: September 7, 2020

Study information

• Verified date: January 2022
• Source: Hanmi Pharmaceutical Company Limited
• 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: September 7, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Locations

Country	Name	City	State
Germany	Investigational Site Number 2760005	Berlin
Germany	Investigational Site Number 2760003	Frankfurt Am Main
Germany	Investigational Site Number 2760001	Leipzig
Poland	Investigational Site Number 6160005	Gdansk
Poland	Investigational Site Number 6160004	Gdynia
Poland	Investigational Site Number 6160007	Katowice
Poland	Investigational Site Number 6160002	Krakow
Poland	Investigational Site Number 6160006	Poznan
Poland	Investigational Site Number 6160003	Warszawa
Poland	Investigational Site Number 6160001	Wroclaw
Ukraine	Investigational Site Number 8040001	Kyiv
Ukraine	Investigational Site Number 8040002	Kyiv
Ukraine	Investigational Site Number 8040003	Kyiv
Ukraine	Investigational Site Number 8040004	Vinnitsa
United Kingdom	Investigational Site Number 8260005	Birmingham
United Kingdom	Investigational Site Number 8260004	Cardiff
United Kingdom	Investigational Site Number 8260007	Chorley
United Kingdom	Investigational Site Number 8260008	Glasgow
United Kingdom	Investigational Site Number 8260001	Hexham
United Kingdom	Investigational Site Number 8260003	Liverpool
United Kingdom	Investigational Site Number 8260006	Manchester
United Kingdom	Investigational Site Number 8260002	Reading
United States	Investigational Site Number 8400004	Birmingham	Alabama
United States	Investigational Site Number 8400001	Bridgeton	New Jersey
United States	Investigational Site Number 8400028	Burlington	North Carolina
United States	Investigational Site Number 8400003	Canoga Park	California
United States	Investigational Site Number 8400017	Carrollton	Texas
United States	Investigational Site Number 8400034	Chicago	Illinois
United States	Investigational Site Number 8400007	Chula Vista	California
United States	Investigational Site Number 8400030	Dallas	Texas
United States	Investigational Site Number 8400010	DeLand	Florida
United States	Investigational Site Number 8400005	Glendale	Arizona
United States	Investigational Site Number 8400008	Hatboro	Pennsylvania
United States	Investigational Site Number 8400006	Hialeah	Florida
United States	Investigational Site Number 8400002	Holladay	Utah
United States	Investigational Site Number 8400015	Houston	Texas
United States	Investigational Site Number 8400033	Kansas City	Missouri
United States	Investigational Site Number 8400011	La Mesa	California
United States	Investigational Site Number 8400021	Las Vegas	Nevada
United States	Investigational Site Number 8400062	Las Vegas	Nevada
United States	Investigational Site Number 8400025	Lawrenceville	Georgia
United States	Investigational Site Number 8400018	Lincoln	Nebraska
United States	Investigational Site Number 8400009	Los Angeles	California
United States	Investigational Site Number 8400013	Maumee	Ohio
United States	Investigational Site Number 8400019	Plano	Texas
United States	Investigational Site Number 8400029	Pomona	California
United States	Investigational Site Number 8400016	San Antonio	Texas
United States	Investigational Site Number 8400020	San Antonio	Texas
United States	Investigational Site Number 8400027	San Antonio	Texas
United States	Investigational Site Number 8400023	Schertz	Texas
United States	Investigational Site Number 8400024	Tarzana	California
United States	Investigational Site Number 8400026	Van Nuys	California
United States	Investigational Site Number 8400032	West Palm Beach	Florida
United States	Investigational Site Number 8400031	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited	Sanofi

Countries where clinical trial is conducted

United States,  Germany,  Poland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Hemoglobin (HbA1c) (%)	Change from Baseline to Week 30 in HbA1c	Baseline to Week 30
Secondary	Change in HbA1c (%)	Change from Baseline to Week 56 in HbA1c	Baseline to Week 56
Secondary	Change in Fasting Plasma Glucose (FPG)	Change from Baseline to Week 30 in FPG	Baseline to Week 30
Secondary	HbA1c <7%	Number of participants with HbA1c <7.0% at Week 30	Week 30
Secondary	Change in Body Weight at Week 30	Change from Baseline to Week 30 in body weight	Baseline to Week 30
Secondary	Change in Body Weight at Week 56	Change from Baseline to Week 56 in body weight	Baseline to Week 56
Secondary	Hypoglycemic Participants	Number of participants with at least 1 hypoglycemic event during treatment period	Baseline to Week 56
Secondary	Hypoglycemic Events	Number of hypoglycemic events	Baseline to Week 56
Secondary	Treatment Emergent Adverse Events (TEAEs)	Number of participants with TEAEs	Baseline to Week 56