A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT02973321
Last Updated: 2022-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
296 participants
INTERVENTIONAL
2016-12-02
2017-12-27
Brief Summary
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The primary objective of this study was to assess the dose-response relationship of SAR425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (HbA1c).
Secondary Objectives:
* To assess the effect of SAR425899 on body weight.
* To assess the safety and immunogenicity profile of SAR425899, including assessment of the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor.
* To assess the proportion of participants achieving predefined HbA1c targets of \<7% and \<6.5% as well as the proportion of participants achieving \>=5% and \>=10% body weight loss.
* To assess the effect of once daily dosing of SAR425899 on additional parameters of glycemic control and lipid metabolism.
* To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic (PD) biomarkers.
* To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual and inter-occasion variability in PK parameters using a population PK approach.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
Placebo
Self-administered by SC injection using a solution for injection in cartridge.
Metformin
Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.
SAR425899 0.12 mg
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
SAR425899
Self-administered by SC injection using a solution for injection in cartridge.
Metformin
Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.
SAR425899 0.16 mg
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
SAR425899
Self-administered by SC injection using a solution for injection in cartridge.
Metformin
Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.
SAR425899 0.20 mg
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
SAR425899
Self-administered by SC injection using a solution for injection in cartridge.
Metformin
Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.
Liraglutide
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
Liraglutide
Self-administered by SC injection using a pre-filled pen.
Metformin
Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.
Interventions
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SAR425899
Self-administered by SC injection using a solution for injection in cartridge.
Placebo
Self-administered by SC injection using a solution for injection in cartridge.
Liraglutide
Self-administered by SC injection using a pre-filled pen.
Metformin
Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening.
* Signed informed consent.
Exclusion Criteria
* Glycated hemoglobin at screening visit \<7.0% or \>10.0%.
* Body mass index (BMI) \<25 kg/m\^2 or \>45.0 kg/m\^2.
* Pregnant or lactating women.
* Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
* Diagnosis of type 1 diabetes mellitus.
* Fasting plasma glucose of \>15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (\>15 mmol/L \[270 mg/dL\]) by a repeat test before randomization.
* Treatment with glucose-lowering agents(s) other than metformin, currently or within the 3 months prior to screening.
* Previous insulin use, except for episode(s) of short-term treatment (≤15 consecutive days) for intercurrent illness or pregnancy, or use of insulin within the last 6 months.
* Contraindication(s) to metformin use.
* Contraindication(s) to liraglutide use.
* Significant change in body weight in the 3 months before screening.
* Poorly controlled hypertension (a resting systolic blood pressure (SBP) \>160 mm Hg and/or diastolic blood pressure (DBP) \>95 mm Hg at screening).
* History of long QT syndrome and/or QTc more than 450 ms at screening visit.
* History of pancreatitis or pancreatectomy.
* History of weight loss surgery.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
* Any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists/GLP-1 analogs.
* Contraindications or known hypersensitivity reaction to glucagon.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
80 Years
ALL
No
Sponsors
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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 8400028
Sheffield, Alabama, United States
Investigational Site Number 8400002
Huntington Park, California, United States
Investigational Site Number 8400024
Los Angeles, California, United States
Investigational Site Number 8400001
Los Angeles, California, United States
Investigational Site Number 8400012
Port Hueneme, California, United States
Investigational Site Number 8400027
Denver, Colorado, United States
Investigational Site Number 8400025
Miami, Florida, United States
Investigational Site Number 8400007
Palm Harbor, Florida, United States
Investigational Site Number 8400013
Chicago, Illinois, United States
Investigational Site Number 8400016
Wichita, Kansas, United States
Investigational Site Number 8400023
Wichita, Kansas, United States
Investigational Site Number 8400018
New Orleans, Louisiana, United States
Investigational Site Number 8400019
Rockville, Maryland, United States
Investigational Site Number 8400014
Flint, Michigan, United States
Investigational Site Number 8400003
Troy, Michigan, United States
Investigational Site Number 8400020
Linden, New Jersey, United States
Investigational Site Number 8400022
New York, New York, United States
Investigational Site Number 8400005
Fargo, North Dakota, United States
Investigational Site Number 8400004
Austin, Texas, United States
Investigational Site Number 8400006
Dallas, Texas, United States
Investigational Site Number 8400021
Houston, Texas, United States
Investigational Site Number 8400026
San Antonio, Texas, United States
Investigational Site Number 8400017
Sugar Land, Texas, United States
Investigational Site Number 1240008
Québec, , Canada
Investigational Site Number 1240005
Sainte-Foy, , Canada
Investigational Site Number 1240002
Sherbrooke, , Canada
Investigational Site Number 1240001
Toronto, , Canada
Investigational Site Number 1240003
Vancouver, , Canada
Investigational Site Number 2030003
České Budějovice, , Czechia
Investigational Site Number 2030001
Krnov, , Czechia
Investigational Site Number 2030004
Praha 10 - Uhrineves, , Czechia
Investigational Site Number 2030002
Praha 9 - Klanovice, , Czechia
Investigational Site Number 2760003
Berlin, , Germany
Investigational Site Number 2760001
Dresden, , Germany
Investigational Site Number 2760006
Hohenmölsen, , Germany
Investigational Site Number 3480001
Balatonfüred, , Hungary
Investigational Site Number 3480002
Budapest, , Hungary
Investigational Site Number 3480008
Budapest, , Hungary
Investigational Site Number 3480005
Budapest, , Hungary
Investigational Site Number 3480006
Budapest, , Hungary
Investigational Site Number 3480007
Budapest, , Hungary
Investigational Site Number 4840004
Actopan, , Mexico
Investigational Site Number 4840001
Guadalajara, , Mexico
Investigational Site Number 4840003
Guadalajara, , Mexico
Investigational Site Number 4840002
Monterrey, , Mexico
Investigational Site Number 4840006
San Juan del Río, , Mexico
Investigational Site Number 6430002
Saint Petersburg, , Russia
Investigational Site Number 6430004
Saint Petersburg, , Russia
Investigational Site Number 6430001
Saint Petersburg, , Russia
Investigational Site Number 6430003
Saratov, , Russia
Investigational Site Number 6430005
Voronezh, , Russia
Investigational Site Number 7240001
A Coruña, , Spain
Investigational Site Number 7240005
Barcelona, , Spain
Investigational Site Number 7240007
Ferrol, , Spain
Investigational Site Number 7240006
Las Palmas de Gran Canaria, , Spain
Investigational Site Number 7240002
Madrid, , Spain
Investigational Site Number 7240003
Málaga, , Spain
Investigational Site Number 7240004
Málaga, , Spain
Investigational Site Number 7240008
Seville, , Spain
Countries
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References
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Schiavon M, Visentin R, Gobel B, Riz M, Cobelli C, Klabunde T, Dalla Man C. Improved postprandial glucose metabolism in type 2 diabetes by the dual glucagon-like peptide-1/glucagon receptor agonist SAR425899 in comparison with liraglutide. Diabetes Obes Metab. 2021 Aug;23(8):1795-1805. doi: 10.1111/dom.14394. Epub 2021 May 5.
Gater A, Reaney M, Findley A, Brun-Strang C, Burrows K, Nguyen-Pascal ML, Roborel de Climens A. Development and First Use of the Patient's Qualitative Assessment of Treatment (PQAT) Questionnaire in Type 2 Diabetes Mellitus to Explore Individualised Benefit-Harm of Drugs Received During Clinical Studies. Drug Saf. 2020 Feb;43(2):119-134. doi: 10.1007/s40264-019-00877-4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001328-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1179-4786
Identifier Type: OTHER
Identifier Source: secondary_id
DRI13940
Identifier Type: -
Identifier Source: org_study_id
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