GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

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, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function \[HOMA-beta\]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Key facts

Study ID: NCT00763815
Run by: Sanofi
People needed: 484
Starts: 2008-09-01
Expected to finish: 2011-06-01
Last updated by the study team: 2016-11-28

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 1 year at the time of the screening visit, insufficiently controlled with pioglitazone

You may not qualify if…

HbA1c less than (<) 7 percent (%) or greater than (>) 10% at screening
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
Pioglitazone not at a stable dose of at least 30 milligram per day (mg/day) for at least 3 months prior to screening
If treatment with metformin, no stable dose of at least 1.5 gram per day (g/day) 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])
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 3 months preceding the screening visit
History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease
History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
Hemoglobinopathy or hemolytic anemia, or receipt of blood or plasma products within3 months prior to the time of screening
History of myocardial infarction or stroke within the last 6 months prior to screening
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 or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively
Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): >2 times upper limit of 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 (HBsAg) and/or Hepatitis C antibody (HCAb); positive serum pregnancy test in females of childbearing potential
Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG), 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)
Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin or pioglitazone (for example, sulfonylurea, alpha-glucosidase inhibitor, other thiazolidinediones, 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 or participation in a previous study with lixisenatide
Renal impairment defined with creatinine >1.4 mg/dL in women and creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment)
Patients with cardiac failure or history of cardiac failure (New York Heart Association class I to IV)

Where it is running

Sanofi-Aventis Investigational Site Number 840744 — Birmingham, Alabama, United States
Sanofi-Aventis Investigational Site Number 840867 — Birmingham, Alabama, United States
Sanofi-Aventis Investigational Site Number 840720 — Birmingham, Alabama, United States
Sanofi-Aventis Investigational Site Number 840855 — Mobile, Alabama, United States
Sanofi-Aventis Investigational Site Number 840863 — Mobile, Alabama, United States
Sanofi-Aventis Investigational Site Number 840775 — Chandler, Arizona, United States
Sanofi-Aventis Investigational Site Number 840722 — Mesa, Arizona, United States
Sanofi-Aventis Investigational Site Number 840769 — Phoenix, Arizona, United States
Sanofi-Aventis Investigational Site Number 840729 — Harrisburg, Arkansas, United States
Sanofi-Aventis Investigational Site Number 840776 — Mountain Home, Arkansas, United States
Sanofi-Aventis Investigational Site Number 840795 — Artesia, California, United States
Sanofi-Aventis Investigational Site Number 840782 — Chino, California, United States
Sanofi-Aventis Investigational Site Number 840785 — Huntington Beach, California, United States
Sanofi-Aventis Investigational Site Number 840858 — La Jolla, California, United States
Sanofi-Aventis Investigational Site Number 840784 — Los Banos, California, United States
Sanofi-Aventis Investigational Site Number 840773 — Mission Hills, California, United States
Sanofi-Aventis Investigational Site Number 840707 — Mission Viejo, California, United States
Sanofi-Aventis Investigational Site Number 840733 — Northridge, California, United States
Sanofi-Aventis Investigational Site Number 840864 — Roseville, California, United States
Sanofi-Aventis Investigational Site Number 840772 — San Diego, California, United States
Sanofi-Aventis Investigational Site Number 840743 — San Mateo, California, United States
Sanofi-Aventis Investigational Site Number 840721 — Stockton, California, United States
Sanofi-Aventis Investigational Site Number 840763 — West Hills, California, United States
Sanofi-Aventis Investigational Site Number 840872 — Colorado Springs, Colorado, United States
Sanofi-Aventis Investigational Site Number 840723 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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