Diabetes MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
sanofi-aventis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: E 01. At the time of screening age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of repeated subcutaneous doses of 20 µg lixisenatide as compared to 1.8 mg liraglutide in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at the end of a 4-week treatment period in patients with type 2 diabetes;Secondary Objective: • To assess the effects of lixisenatide as compared to liraglutide after a 4-week treatment period in patients with type 2 diabetes: - on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast - on the 24-h profile of plasma glucose - on HbA1c - on satiety markers (obestatin, PYY-36 and oxyntomodulin) • To assess the clinical and laboratory safety profile of lixisenatide and liraglutide over a 4-week treatment period in patients with type 2 diabetes ;Primary end point(s): • GLU-AUC0:30-4:30h: area under the plasma glucose concentration time profile calculated using the linear trapezoidal rule from time of standardized breakfast start (30 min after IP injection=T0.5) until 4 hours later (T4.5) | — |
Countries
Germany
Outcome results
None listed