Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2013-002945-12-HU
• Date of registration: 23/09/2014
• Prospective Registration: No
• Primary sponsor: Sanofi-aventis recherche et développement
• Public title: Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
• Scientific title: Six-month, Randomized, Open-label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, with a 6-month Safety Extension Period - SORELLA 1
• Date of first enrolment: 22/09/2014
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002945-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany, Hungary, Japan, Mexico, Poland, Russian Federation, Spain, United States

Contacts

• Name: NA.
• Affiliation: sanofi-aventis Zrt.

• Name: NA.
• Affiliation: sanofi-aventis Zrt.

Key inclusion & exclusion criteria

Inclusion criteria:
- 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

Exclusion criteria:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type1-Diabetes
MedDRA version: 17.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Code: SAR342434
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133 107-64-9
Current Sponsor code: SAR342434
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Humalog
Product Name: Humalog
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: baseline, 26 weeks

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

Primary end point(s): Change in HbA1c from baseline

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.
- To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension.
- 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)
profiles, and insulin dose.
- To assess safety of SAR342434 and Humalog.

Secondary Outcome(s)

Secondary end point(s): 1 - Percentage of patients with HbA1c <7%
2 - Change in FPG from baseline
3 - Change in the mean 24-hour plasma glucose concentration, based on the 7-point self measured plasma glucose profile from baseline
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
5 - Number of patients with hypoglycemia event
6 - Number of hypoglycemia events per patient

Timepoint(s) of evaluation of this end point: 1, 5 and 6 : 26 weeks
2, 3 and 4: baseline, 26 weeks

Secondary ID(s)

2013-002945-12-DE

EFC12619

Source(s) of Monetary Support

Sanofi-aventis recherche et développement