GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy
NCT ID: NCT00688701
Last Updated: 2016-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
361 participants
INTERVENTIONAL
2008-05-31
2009-12-31
Brief Summary
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The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12.
Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and 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
QUADRUPLE
Study Groups
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Placebo (Two-Step Titration)
2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
Placebo
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector
Placebo (One-Step Titration)
1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12.
Placebo
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector
Lixisenatide (Two-Step Titration)
2-step initiation regimen of lixisenatide: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
Lixisenatide (AVE0010)
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector
Lixisenatide (One-Step Titration)
1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12.
Lixisenatide (AVE0010)
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* At the time of screening age \< legal age of majority
* Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
* Type 1 diabetes mellitus
* Type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study
* Fasting plasma glucose at screening \>250 milligram per deciliter (mg/dL) (\>13.9 millimole per liter \[mmol/L\])
* Body mass index less than or equal to (\<=) 20 kilogram per square meter (kg/m\^2)
* Weight change of more than 5 kg during the previous 3 months
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
* History of metabolic acidosis, including diabetic ketoacidosis within the previous year
* Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within the previous 3 months
* History of myocardial infarction, stroke, or heart failure requiring hospitalization within the previous 6 months
* Known history of drug or alcohol abuse within the previous 6 months
* 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 with a resting supine systolic or diastolic blood pressure \>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 the upper limit of the normal (ULN) laboratory range; amylase and/or lipase: \>3 ULN; total bilirubin: \>1.5 ULN (except in case of Gilbert's syndrome); hemoglobin \<11 gram/deciliter (g/dL) and/or neutrophils \<1,500 per cubic mm (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 by physical examination, laboratory tests, electrocardiogram or vital sign at the time of screening that in the judgment of the investigator or any sub investigator precludes safe completion of the study or hinders the efficacy assessment
* Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason
* Use of systemic glucocorticoids (excluding topical application or inhaled forms) within the previous 3 months
* Participation in any previous study with lixisenatide
* Use of any investigational drug within 3 months prior to study
* End-stage renal disease as defined by a calculated serum creatinine clearance of \<15 milliliter/minute and/or patients on dialysis
* 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 the previous 6 months
* History of allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past 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
Diegem, , Belgium
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Netanya, , Israel
Sanofi-Aventis Administrative Office
Tokyo, , Japan
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Mégrine, , Tunisia
Sanofi-Aventis Administrative Office
Kiev, , Ukraine
Countries
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References
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Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012 Jun;35(6):1225-31. doi: 10.2337/dc11-1935. Epub 2012 Mar 19.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Other Identifiers
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EudraCT 2007-005887-29
Identifier Type: -
Identifier Source: secondary_id
EFC6018
Identifier Type: -
Identifier Source: org_study_id