Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: lixisenatide AVE0010 (Drug); liraglutide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
International Clinical Development Study Director, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
For site information, send an email with site number to, Email: GV-contact-us@sanofi-aventis.com

Primary Objective:

- To investigate the effects of lixisenatide as compared to liraglutide in reducing

Postprandial Plasma Glucose (PPG) after a standardized breakfast in patients with type 2 diabetes

Secondary Objectives:

- 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 Glycosylated hemoglobin (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

Official title: An Open-label, Randomized 2-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 Metformin

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Postprandial plasma glucose (PPG)

Secondary outcome:

Insulin, pro-insulin, C-peptide and glucagon plasma concentrations

Glycosylated hemoglobin (HbA1c)

Satiety markers: PYY-36, oxyntomodulin and obestatin

Detailed description: The duration of the study for each patient was up to 7 weeks including a screening period up to 2 weeks, a treatment period of 4 weeks (Day 1 to Day 28), and an end-of-study visit 7± 2 days after the last dose.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Patients with type 2 diabetes mellitus as defined by World Health Organization

(fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11. 1 mmol/L (200 mg/dL)), diagnosed 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

- Glycosylated hemoglobin HbA1c ≥ 6. 5% (as recommended by the American Diabetes

Association) and HbA1c ≤ 9% at screening

Exclusion criteria:

- At the time of screening age < 18 years or ≥ 74 years

- Body Mass Index (BMI) : ≤ 20 kg/m² or ≥ 37 kg/m²

- Pregnant women or breast feeding women

- Women of childbearing potential with no effective contraceptive method

- Use of other oral or injectable antidiabetic or hypoglycemic agents other than

metformin (e. g., alpha glucosidase inhibitor, exenatide, Dipeptidyl peptide IV (DPP-IV) inhibitors, insulin, thiazolidinedione (TZD), sulfonylurea (SU) etc.) within 3 months prior to the time of screening

- Allergic reaction to any GLP-1 agonist in the past (e. g. exenatide) or to metacresol

- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,

stomach/gastric surgery, inflammatory bowel disease

- Personal or family history of Medullary Thyroid Cancer (MTC) or a genetic condition

that predisposes to MTC

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

For site information, send an email with site number to, Email: GV-contact-us@sanofi-aventis.com

Sanofi-Aventis Investigational Site Number 276006, Berlin 14050, Germany; Recruiting

Sanofi-Aventis Investigational Site Number 276004, Kiel 24105, Germany; Recruiting

Sanofi-Aventis Investigational Site Number 276002, Mainz 55116, Germany; Recruiting

Sanofi-Aventis Investigational Site Number 276003, Mannheim 68167, Germany; Recruiting

Sanofi-Aventis Investigational Site Number 276005, Mönchengladbach 41061, Germany; Recruiting

Sanofi-Aventis Investigational Site Number 276007, München 80636, Germany; Recruiting

Sanofi-Aventis Investigational Site Number 276001, Neuss 41460, Germany; Recruiting

Starting date: August 2010
Last updated: September 10, 2010