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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 (SORELLA1)

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ClinicalTrials.gov Identifier: NCT02273180
Recruitment Status : Completed
First Posted : October 23, 2014
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants 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 participants reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: SAR342434 Drug: Humalog Drug: Insulin glargine HOE901 Phase 3

Detailed Description:

The study consisted 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 would be 54 weeks per participant and a 1-day safety follow-up

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
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
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: SAR342434
SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
Drug: SAR342434
SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by deep subcutaneous (SC) injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour post prandial plasma glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.

Drug: Insulin glargine HOE901
Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.
Other Name: Lantus

Active Comparator: Humalog
Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.
Drug: Humalog
Humalog 100 U/mL (dose range of 1 unit to 60 units) self-administered by deep SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycaemia.
Other Name: Insulin Lispro

Drug: Insulin glargine HOE901
Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.
Other Name: Lantus




Primary Outcome Measures :
  1. Change in HbA1c From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
    Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26.


Secondary Outcome Measures :
  1. Percentage of Participants With HbA1c <7.0% at Week 26 [ Time Frame: Week 26 ]
    Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
    Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26.

  3. Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
    Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.

  4. Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
    Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.

  5. Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year [ Time Frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days) ]
    Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed.

  6. Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions [ Time Frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days) ]
    Percentage of participants with hypersensitivity reactions and injection site reactions were reported.

  7. Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs) [ Time Frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days) ]
    Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).


Other Outcome Measures:
  1. Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 [ Time Frame: Baseline, Week 26, Week 52 ]
    Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively.



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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participants with T1DM diagnosed for at least 12 months and had 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 participant's potential participation in a clinical trial.


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


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Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Publications:
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 Posted: October 23, 2014    Key Record Dates
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018
Last Verified: December 2017

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
Hypoglycemic Agents
Physiological Effects of Drugs