Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
- Conditions
- Type2-DiabetesMedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-002844-42-ES
- Lead Sponsor
- Sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
-Patients with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog 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
-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
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus (T2DM) also using insulin glargine;Secondary Objective: -To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study;<br>-To assess the relationship of anti-insulin antibodies with efficacy and safety.<br>-To assess the efficacy of SAR342434 and Humalog on: proportion of patients reaching target HbA1c <7.0% and ?6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose.<br>-To assess safety of SAR342434 and Humalog.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to 26 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1 - Percentage of patients with HbA1c <7.0% and ?6.5%<br>2 - Change in FPG <br>3 - Change in the mean 24-hour plasma glucose concentration, based on the 7-point Self Measured Plasma Glucose profile<br>4 - Change in postprandial plasma glucose excursions (difference between 2 hour postprandial and pre-prandial plasma glucose values at breakfast, lunch, and dinner) <br>5 - Number of patients with hypoglycemia event <br>6 - Number of hypoglycemia events per patient<br>7 - Number of patients with injection site reactions<br>8 - Number of patients with hypersensitivity reactions<br>9 - Number of patients with adverse events;Timepoint(s) of evaluation of this end point: 1 : at 26 weeks<br>2, 3 and 4: from baseline to 26 weeks<br>5, 6, 7, 8 and 9: up to 26 weeks