Pharmacodynamic effects of lixisenatide compared to liraglutide in patients with type 2 diabetes not adequately controlled with insulin glargine with or without metformin.

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 15.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-000027-40-DE
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-14
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients with T2DM diagnosed at least 1 year before the screening visit
•Treatment with neutral protamine hagedorn (NPH) or insulin glargine for at least 3 months and at a stable dose (±20%) of at least 10 IU/day (for at least 2 months prior to screening) alone or combined with a stable dose of metformin with without DPP-4 or sulfonylurea
•Glycosylated hemoglobin (HbA1c) =6.5 and =9.5%
• Body mass index (BMI) between 20 and 40 kg/m2
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Pregnant women or breastfeeding women
•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening
•Any previous treatment with lixisenatide or participation in a previous study with lixisenatide (AVE0010), and any previous treatment with liraglutide stopped for safety concern or lack of efficacy
•Allergic reaction to any GLP-1 agonist in the past (eg, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified