An open-label, randomized, two-arm parallel group study to compare the effects of 4-week QD treatment with lixisenatide or liraglutide on the postprandial plasma glucose in patients with type 2 diabetes not adequately controlled with metformi
- Conditions
- DiabetesMedDRA version: 12.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2009-017666-23-DE
- Lead Sponsor
- sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
I 01. Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose = 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose = 11.1 mmol/L (200 mg/dL)), for at least 1 year at the time of screening visit, not adequately controlled by metformin at a dose of at least 1.5 g/day for at least 3 months prior to screening
I 02. HbA1c = 6.5% (as recommended by the American Diabetes Association (11)) and HbA1c = 9% at screening
I 03. Covered by Health Insurance System where applicable, and/or in compliance with the recommendations of the National (German) Law in force relating to biomedical research
I 04. Not under any administrative or legal supervision
I 05. Written informed consent obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
E 01. At the time of screening age < 18 year or =75 years
E 02. Body Mass Index (BMI) : = 20 kg/m² or = 37 kg/m²
E 03. History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
E 04. Hemoglobinopathy or hemolytic anemia
E 05. History of myocardial infarction, stroke, or heart failure requiring hospitalization within 6 months prior to the time of screening, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
E 06. 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 (euthyroid patients on replacement therapy will be included if the dosage of thyroxin is stable for at least three months prior to screening Visit)
E 07. Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 160 mmHg or > 95 mmHg, respectively
E 08. 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 would preclude safe completion of the study
E 09. Receipt of blood or plasma products within 3 months prior to the time of screening
E 10. Investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol
E 11. Patients considered by the investigator or any sub investigator as inappropriate for this study for any reason (e.g. impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, etc)
E 12. Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin, TZD, SU etc.) within 3 months prior to the time of screening
E 13. 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 14. Likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol
E 15. Use of any investigational drug within 3 months prior to screening
E 16. Pregnant women or breast feeding women
E 17. Women of childbearing potential with no effective contraceptive method
Female patients of childbearing potential (pre-menopausal, less than two years post-menopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative blood ß-HCG pregnancy test prior to enrollment and Baseline visit, accept to repeat pregnancy test at designated visits and they must use a highly effective method of birth control during the whole study, which is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, 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) (12) and according to the following double contraception algorithm [(intra-uterine device or hormonal contraception) plus (spermicide-coated condom or diaphragm)].
E 18. Clinically relevant history of gast
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