Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

Phase 1

• Conditions: Type2-Diabetes; MedDRA version: 18.1Level: 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: EUCTR2014-002844-42-DE
• Lead Sponsor: Sanofi-aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-11
• Last Update Posted: 19 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

-Patients with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/ Liprolog® or NovoLog® / NovoRapid® (at least 3 times daily, before each meal) in the last 6 months prior to the screening visit.

-Signed Written informed consent.

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 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

-At screening visit, age under legal age of adulthood.
-HbA1c <6.5% or >10.0% at screening.
-Diabetes other than T2DM.
-Pregnancy and lactation.
-Women of childbearing potential not protected by highly effective contraceptive method of birth control.
-Use of insulin pump in the 6 months before screening visit.
-Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an EU approved insulin lispro and is allowed in those countries where it is marketed.
-Use of Humalog or Novolog/NovoRapid less than 3 times daily, before each meal.
-Use of non-injectable peptides (eg, GLP-1-receptor-agonists or other peptides) in the 6 months prior to screening visit.
-Body mass index (BMI) =40kg/m² at screening visit.
-Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
-Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.

Study & Design

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