GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. 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.

Key facts

Study ID: NCT00688701
Run by: Sanofi
People needed: 361
Starts: 2008-05-01
Expected to finish: 2009-12-01
Last updated by the study team: 2016-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Type 2 diabetes mellitus, diagnosed for at least 2 months at the time of the screening visit, not treated with any antidiabetic agent

You may not qualify if…

HbA1c less than (<) 7 percent (%) or greater than (>) 10%
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
Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase: more than 2 injections missed; and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator

Where it is running

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

Full record on ClinicalTrials.gov

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