Efficacy and safety of insulin glargine/lixisenatide fixed combination versus insulin glargine alone on top of metformin in type 2 diabetic patients

• Conditions: Type II Diabetes Mellitus; MedDRA version: 14.0Level: 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: EUCTR2011-002090-36-SK
• Lead Sponsor: sanofi-aventis Recherche et Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-08
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

- Patient with type 2 diabetes mellitus diagnosed for at least 1 year.
- Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening
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 248
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

- Age < legal age of adulthood
- Screening HbA1c < 7% or > 10%
- Screening FPG > 250 mg/dL (> 13.9 mmol/L)
- Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
- Type 1 diabetes mellitus
- Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening
- Use of insulin within the last 6 months
- Previous use of insulin, except for episode(s) of short-term treatment (= 15 consecutive days) due to intercurrent illness
- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN) at screening
- Calcitonin = 20 pg/ml (5.9 pmol/l) at screening
- Alanine Transferase (ALT)> 3ULN at screening
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g multiple endocrine neoplasia syndromes)
- Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively
- Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures
- Body Mass Index (BMI) = 20 or > 40 kg/m²
- Any previous treatment with lixisenatide

Study & Design

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