Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
NCT ID: NCT03684642
Last Updated: 2021-11-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
908 participants
INTERVENTIONAL
2018-09-26
2020-11-17
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Efpeglenatide 4 mg
Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.
Efpeglenatide
Pharmaceutical form: solution for injection; Route of administration: SC
Background therapy Metformin
Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.
Efpeglenatide 6 mg
Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.
Efpeglenatide
Pharmaceutical form: solution for injection; Route of administration: SC
Background therapy Metformin
Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.
Dulaglutide 1.5 mg
Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Dulaglutide
Pharmaceutical form: solution for injection; Route of administration: SC
Background therapy Metformin
Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.
Interventions
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Efpeglenatide
Pharmaceutical form: solution for injection; Route of administration: SC
Dulaglutide
Pharmaceutical form: solution for injection; Route of administration: SC
Background therapy Metformin
Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 8400038
Birmingham, Alabama, United States
Investigational Site Number 8400035
Chandler, Arizona, United States
Investigational Site Number 8400005
Glendale, Arizona, United States
Investigational Site Number 8400054
Peoria, Arizona, United States
Investigational Site Number 8400057
Huntington Park, California, United States
Investigational Site Number 8400009
Los Angeles, California, United States
Investigational Site Number 8400007
San Diego, California, United States
Investigational Site Number 8400045
Spring Valley, California, United States
Investigational Site Number 8400040
Tustin, California, United States
Investigational Site Number 8400026
Van Nuys, California, United States
Investigational Site Number 8400050
Waterbury, Connecticut, United States
Investigational Site Number 8400055
Orlando, Florida, United States
Investigational Site Number 8400041
Pembroke Pines, Florida, United States
Investigational Site Number 8400025
Lawrenceville, Georgia, United States
Investigational Site Number 8400060
Meridian, Idaho, United States
Investigational Site Number 8400059
Skokie, Illinois, United States
Investigational Site Number 8400044
Lexington, Kentucky, United States
Investigational Site Number 8400061
Boston, Massachusetts, United States
Investigational Site Number 8400001
Bridgeton, New Jersey, United States
Investigational Site Number 8400039
New Windsor, New York, United States
Investigational Site Number 8400028
Burlington, North Carolina, United States
Investigational Site Number 8400036
Morehead City, North Carolina, United States
Investigational Site Number 8400013
Maumee, Ohio, United States
Investigational Site Number 8400014
Goose Creek, South Carolina, United States
Investigational Site Number 8400030
Dallas, Texas, United States
Investigational Site Number 8400020
San Antonio, Texas, United States
Investigational Site Number 8400043
San Antonio, Texas, United States
Investigational Site Number 8400053
San Antonio, Texas, United States
Investigational Site Number 8400037
Layton, Utah, United States
Investigational Site Number 8400049
Manassas, Virginia, United States
Investigational Site Number 3480004
Budapest, , Hungary
Investigational Site Number 3480003
Debrecen, , Hungary
Investigational Site Number 3480001
Gyula, , Hungary
Investigational Site Number 3480005
Hatvan, , Hungary
Investigational Site Number 3480002
Nyíregyháza, , Hungary
Investigational Site Number 6160008
Gdansk, , Poland
Investigational Site Number 6160004
Gdynia, , Poland
Investigational Site Number 6160010
Katowice, , Poland
Investigational Site Number 6160009
Poznan, , Poland
Investigational Site Number 6160003
Warsaw, , Poland
Investigational Site Number 6160001
Wroclaw, , Poland
Investigational Site Number 8040003
Kyiv, , Ukraine
Investigational Site Number 8040001
Kyiv, , Ukraine
Investigational Site Number 8040002
Kyiv, , Ukraine
Investigational Site Number 8040004
Vinnytsia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002956-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1205-3150
Identifier Type: OTHER
Identifier Source: secondary_id
EFC14829
Identifier Type: -
Identifier Source: org_study_id