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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02273180
First Posted: October 23, 2014
Last Update Posted: December 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

Primary 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 Objectives:

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus Drug: SAR342434 Drug: Humalog Drug: insulin glargine HOE901 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c from baseline [ Time Frame: baseline, 26 weeks ]

Secondary Outcome Measures:
  • Percentage of patients with HbA1c <7% [ Time Frame: 26 weeks ]
  • Change in FPG from baseline [ Time Frame: baseline, 26 weeks ]
  • Change in the mean 24-hour plasma glucose concentration, based on the 7-point self measured plasma glucose profile from baseline [ Time Frame: baseline, 26 weeks ]
  • Change in postprandial plasma glucose excursions (difference between 2 hour postprandial and pre-prandial plasma glucose values at breakfast, lunch, and dinner) from baseline [ Time Frame: baseline, 26 weeks ]
  • Number of patients with hypoglycemia event [ Time Frame: 26 weeks ]
  • Number of hypoglycemia events per patient [ Time Frame: 26 weeks ]

Enrollment: 507
Study Start Date: October 2014
Study Completion Date: July 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR342434
SAR342434 given before all meals and snacks as mealtime rapid acting insulin on top of glargine as the basal insulin
Drug: SAR342434
Pharmaceutical form:solution Route of administration: subcutaneous
Drug: insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: Lantus
Active Comparator: Humalog
Humalog given before all meals and snacks as mealtime rapid acting insulin on top of glargine as the basal insulin
Drug: Humalog
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: Insulin Lispro
Drug: insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: Lantus

Detailed Description:

The study will consist of a:

  • Up to 2 weeks screening period
  • 26-week treatment period
  • 26-week comparative safety extension period
  • 1-day follow-up period.
  • The maximum study duration will then be 54 weeks per patient and a 1-day safety follow-up.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273180


  Show 89 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02273180     History of Changes
Other Study ID Numbers: EFC12619
2013-002945-12 ( EudraCT Number )
U1111-1131-5038 ( Other Identifier: UTN )
First Submitted: October 21, 2014
First Posted: October 23, 2014
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin Lispro
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs