A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin - ND
- Conditions
- Type II DiabetesMedDRA version: 9.1Level: LLTClassification code 10049746
- Registration Number
- EUCTR2008-007335-40-IT
- Lead Sponsor
- Sanofi-Aventis Recherche & De`veloppement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
Patients meeting all of the following inclusion criteria will be screened: I 01. Patients with type 2 diabetes mellitus, as defined by WHO, diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit. In addition to metformin, patients may receive sulfonylureas (that must be discontinued at visit 1) and/or thiazolidinediones (that can be continued). I 02. Written informed consent obtained At the end of the screening period (screening phase + run-in phase), patients with insufficient glycemic control (see E 27 and E 28) will enter the double-blind randomized treatment period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
E 01.At screening age < legal age of majority E 02.At screening: HbA1c < 7.0 or HbA1c >10% E 03.Pregnancy or lactation E 04.Women of childbearing potential with no effective contraceptive method.Women of childbearing potential (pre-menopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative serum pregnancy test at screening visit.They must use an effective contraceptive method throughout the study, and agree to repeat pregnancy tests at designated visits.The applied methods of contraception have to meet the criteria for a highly effective method of birth control according to the Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95, modification) E 05.Type 1 diabetes mellitus E 06.Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit.E 07.Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea and thiazolidinediones (e.g., alpha glucosidase inhibitor, other GPL-1 receptor agonists, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening E 08.History of hypoglycemia unawareness.E 09.Body Mass Index (BMI) ≤20 kg/m? E 10.History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease E 11.History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening E 12.Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening E 13.Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization E 14.Known history of drug or alcohol abuse within 6 months prior to the time of screening E 15.Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator or any sub investigator would preclude safe completion of the study or constrains efficacy assessment such as major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period.E 16.Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively E 17.Laboratory findings at the time of screening: Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ALT > 3 ULN Total bilirubin: > 1.5 times the upper limit of the normal laboratory range (except in case of Gilberts syndrome) Hemoglobin < 11 g/dL and/or neutrophils < 1,500/mm3 and/or platelets < 100,000/mm3 Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody Positive serum pregnancy test in females of childbearing potential E 19.Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening E 20.Use of any investigational drug within 3 months prior to screening E 21.Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men E 22.History of hypersensitivity to insulin glargine or to any of the excipients E 23.Clinically relevant history of gastrointestinal disease associated with prolonged nausea and
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method