GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea
NCT ID: NCT00713830
Last Updated: 2016-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
859 participants
INTERVENTIONAL
2008-07-31
2011-01-31
Brief Summary
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The primary objective is to assess the effects of lixisenatide when added to sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.
The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (\<) 7 percent (%); percentage of patients reaching HbA1c less than or equal to (\<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lixisenatide
2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Lixisenatide (AVE0010)
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector
Sulfonylurea
Sulfonylurea to be continued at maximum effective dose according to local labeling up to end of treatment.
Metformin
Metformin if given to be continued at stable dose (at least 1.5 gram per day \[except at least 0.75 gram per day in Japan and 1.0 gram per day in South Korea\]) up to the end of treatment.
Placebo
2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Placebo
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector
Sulfonylurea
Sulfonylurea to be continued at maximum effective dose according to local labeling up to end of treatment.
Metformin
Metformin if given to be continued at stable dose (at least 1.5 gram per day \[except at least 0.75 gram per day in Japan and 1.0 gram per day in South Korea\]) up to the end of treatment.
Interventions
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Lixisenatide (AVE0010)
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Placebo
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector
Sulfonylurea
Sulfonylurea to be continued at maximum effective dose according to local labeling up to end of treatment.
Metformin
Metformin if given to be continued at stable dose (at least 1.5 gram per day \[except at least 0.75 gram per day in Japan and 1.0 gram per day in South Korea\]) up to the end of treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* At the time of screening age less than legal age of majority
* Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
* Type 1 diabetes mellitus
* Sulfonylurea less than the maximum effective dose according to local labeling
* Sulfonylurea not at a stable (unchanged) dose for at least 3 months prior to screening
* In case of treatment with metformin in association with sulfonylurea, no stable (unchanged) treatment with metformin of at least 1.5 gram per day (except at least 0.75 gram per day in Japan and at least 1.0 gram per day in South Korea), for at least 3 months prior to screening visit
* FPG at screening \>250 milligram per deciliter (mg/dL) (\>13.9 millimole per liter \[mmol/L\])
* History of hypoglycemia unawareness
* Body mass index less than or equal to (\<=) 20 kilogram per square meter (kg/m\^2)
* Weight change of \>5 kg during the 3 months preceding the screening visit
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
* History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
* Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening
* Within the last 6 months prior to screening, history of myocardial infarction, stroke, or heart failure requiring hospitalization
* Known history of drug or alcohol abuse within 6 months prior to the time of screening
* Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
* Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure (SBP) or diastolic blood pressure (DBP) \>180 millimeter of mercury (mmHg) or \>95 mmHg, respectively
* Laboratory findings at the time of screening: aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase: \>2 times upper limit of the normal (ULN) laboratory range; amylase and/or lipase: \>3 times ULN; total bilirubin: \>1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin \<11 gram/deciliter and/or neutrophils \<1500 per cubic millimeter (mm\^3) and/or platelets \<100 000/mm\^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
* Any clinically significant abnormality identified on physical examination, laboratory tests or vital signs at the time of screening that in the judgment of the Investigator or any sub investigator precludes safe completion of the study or constrains efficacy assessment
* Patients who are considered by the Investigator or any sub investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol, Investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)
* Patients with condition/concomitant diseases making them non-evaluable for the efficacy assessment
* Use of oral or injectable antidiabetic or hypoglycemic agents other than sulfonylurea and metformin (for example, alpha glucosidase inhibitor, thiazolidinedione, rimonabant, exenatide, dipeptidyl-peptidase 4 (DPP-4) inhibitors, insulin) within 3 months prior to the time of screening
* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening
* Use of any investigational drug within 3 months prior to study
* Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)
* Renal impairment defined with serum creatinine \>1.4 mg/dL in women and serum creatinine \>1.5 mg/dL in men (applicable only for patients with metformin treatment)
* End-stage renal disease as defined by a serum creatinine clearance of \<15 milliliter/minute (calculated by the Cockcroft and Gault formula) and/or patients on dialysis (if no treatment with metformin)
* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
* Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example, exenatide, liraglutide) or to metacresol
18 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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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Sofia, , Bulgaria
Sanofi-Aventis Administrative Office
Prague, , Czechia
Sanofi-Aventis Administrative Office
Cairo, , Egypt
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Netanya, , Israel
Sanofi-Aventis Administrative Office
Tokyo, , Japan
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Sanofi-Aventis Administrative Office
Bangkok, , Thailand
Sanofi-Aventis Administrative Office
Mégrine, , Tunisia
Sanofi-Aventis Administrative Office
Istanbul, , Turkey (Türkiye)
Countries
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References
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Rosenstock J, Hanefeld M, Shamanna P, Min KW, Boka G, Miossec P, Zhou T, Muehlen-Bartmer I, Ratner RE. Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S). J Diabetes Complications. 2014 May-Jun;28(3):386-92. doi: 10.1016/j.jdiacomp.2014.01.012. Epub 2014 Jan 28.
Ahren B, Galstyan G, Gautier JF, Giorgino F, Gomez-Peralta F, Krebs M, Nikonova E, Stager W, Vargas-Uricoechea H. Postprandial Glucagon Reductions Correlate to Reductions in Postprandial Glucose and Glycated Hemoglobin with Lixisenatide Treatment in Type 2 Diabetes Mellitus: A Post Hoc Analysis. Diabetes Ther. 2016 Sep;7(3):583-90. doi: 10.1007/s13300-016-0179-6. Epub 2016 Jun 18.
Yabe D, Ambos A, Cariou B, Duvnjak L, Evans M, Gonzalez-Galvez G, Lin J, Nikonova EV, de Pablos-Velasco P, Yale JF, Ahren B. Efficacy of lixisenatide in patients with type 2 diabetes: A post hoc analysis of patients with diverse beta-cell function in the GetGoal-M and GetGoal-S trials. J Diabetes Complications. 2016 Sep-Oct;30(7):1385-92. doi: 10.1016/j.jdiacomp.2016.05.018. Epub 2016 May 24.
Seino H, Onishi Y, Naito Y, Komatsu M. Lixisenatide improves glycemic outcomes of Japanese patients with type 2 diabetes: a meta-analysis. Diabetol Metab Syndr. 2016 Jun 1;8:36. doi: 10.1186/s13098-016-0151-7. eCollection 2016.
Other Identifiers
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EudraCT 2007-005881-11
Identifier Type: -
Identifier Source: secondary_id
EFC6015
Identifier Type: -
Identifier Source: org_study_id