Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
- Conditions
- Type1-DiabetesMedDRA version: 17.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-002945-12-HU
- Lead Sponsor
- Sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
- Patients with T1DM diagnosed for at least 12 months and have been treated with insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit.
- 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 <7.0% or >10% at screening.
- Diabetes other than T1DM.
- Status post pancreatectomy.
- Status post pancreas and/or islet cell transplantation.
- Pregnancy and lactation.
- Women of childbearing potential not protected by highly effective contraceptive method of birth control.
- Less than 1 year on continuous insulin treatment.
- Use of insulin pump in the last 6 months before screening visit.
- Use of glucose lowering treatments other than insulin including non-insulin injectable peptides in the last 6 months prior to screening visit.
- Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before screening visit. Liprolog® is a European Union approved insulin lispro and is allowed in those countries where it is marketed.
- 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 HbA1c change in patients with type 1 diabetes mellitus (T1DM) 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 including during the safety extension.<br>- To assess the efficacy of SAR342434 and Humalog in terms of proportion of patients reaching target HbA1c (<7%) and on fasting plasma glucose (FPG), self-measured plasma glucose (SMPG)<br>profiles, and insulin dose.<br>- To assess safety of SAR342434 and Humalog.;Primary end point(s): Change in HbA1c from baseline ;Timepoint(s) of evaluation of this end point: baseline, 26 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1 - Percentage of patients with HbA1c <7% <br>2 - Change in FPG from baseline <br>3 - Change in the mean 24-hour plasma glucose concentration, based on the 7-point self measured plasma glucose profile from baseline <br>4 - Change in postprandial plasma glucose excursions (difference between 2 hour postprandial and pre-prandial plasma glucose values at breakfast, lunch, and dinner) from baseline<br>5 - Number of patients with hypoglycemia event <br>6 - Number of hypoglycemia events per patient;Timepoint(s) of evaluation of this end point: 1, 5 and 6 : 26 weeks<br>2, 3 and 4: baseline, 26 weeks