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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002945-12-DE

Enrollment

700

Registered

2014-08-07

Start date

2014-11-12

Completion date

Unknown

Last updated

2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1-Diabetes MedDRA version: 17.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

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: I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: At screening visit, age under legal age of adulthood. HbA1c 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.

Design outcomes

Primary

Measure	Time frame
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. - 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 on: fasting plasma glucose (FPG) and self measured plasma glucose (SMPG) profiles. - 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	—

Measure

Time frame

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. - 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 on: fasting plasma glucose (FPG) and self measured plasma glucose (SMPG) profiles. - 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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

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

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026