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: 17.0Level: 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-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
- 700
Patients with T1DM diagnosed for at least 12 months, and have been on basal bolus therapy using insulin glargine and Humalog or Novolog®/Novo Rapid® for at least 6 months.
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.
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 change in anti-insulin antibodies.<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 on: fasting plasma glucose (FPG) and self measured plasma glucose (SMPG) profiles.<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