Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine (SORELLA2)

December 20, 2017 updated by: Sanofi

Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) 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. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c <7.0% and <=6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period.

The maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.

Study Type

Interventional

Enrollment (Actual)

505

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, C1425AGC
        • Investigational Site Number 032201
      • Capital Federal, Argentina, C1056ABJ
        • Investigational Site Number 032206
      • Capital Federal, Argentina, C1179AAB
        • Investigational Site Number 032202
      • Ciudad Autonoma De Buenos Aire, Argentina
        • Investigational Site Number 032205
      • Salta, Argentina, 4400
        • Investigational Site Number 032203
  • Chile
      • Santiago, Chile, 7500347
        • Investigational Site Number 152202
      • Santiago, Chile, 7500347
        • Investigational Site Number 152204
      • Santiago, Chile, 7500710
        • Investigational Site Number 152201
  • Colombia
      • Armenia, Colombia, 630004
        • Investigational Site Number 170203
  • Germany
      • Berlin, Germany, 10115
        • Investigational Site Number 276201
      • Heidelberg, Germany, 69115
        • Investigational Site Number 276204
      • Neumünster, Germany, 24534
        • Investigational Site Number 276202
      • Potsdam, Germany, 14469
        • Investigational Site Number 276206
      • Stuttgart, Germany, 70378
        • Investigational Site Number 276205
      • Sulzbach-Rosenberg, Germany, 92237
        • Investigational Site Number 276203
  • Hungary
      • Budapest, Hungary, 1036
        • Investigational Site Number 348205
      • Budapest, Hungary, 1135
        • Investigational Site Number 348202
      • Debrecen, Hungary, 4032
        • Investigational Site Number 348204
      • Komárom, Hungary, 2900
        • Investigational Site Number 348208
      • Nagykanizsa, Hungary, 8800
        • Investigational Site Number 348210
      • Szolnok, Hungary, 5004
        • Investigational Site Number 348203
      • Sátoraljaújhely, Hungary, 3980
        • Investigational Site Number 348209
  • Italy
      • Bologna, Italy, 40138
        • Investigational Site Number 380203
      • Milano, Italy, 20132
        • Investigational Site Number 380201
      • Roma, Italy, 00133
        • Investigational Site Number 380204
      • Sesto San Giovanni, Italy, 20099
        • Investigational Site Number 380202
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-746
        • Investigational Site Number 410202
      • Seoul, Korea, Republic of, 130-872
        • Investigational Site Number 410204
      • Seoul, Korea, Republic of, 139-872
        • Investigational Site Number 410205
      • Wonju, Korea, Republic of, 220-701
        • Investigational Site Number 410201
  • Romania
      • Bacau, Romania, 600154
        • Investigational Site Number 642210
      • Bucuresti, Romania, 020042
        • Investigational Site Number 642201
      • Bucuresti, Romania, 020042
        • Investigational Site Number 642202
      • Cluj Napoca, Romania, 400006
        • Investigational Site Number 642206
      • Deva, Romania, 330084
        • Investigational Site Number 642204
      • Oradea, Romania, 410159
        • Investigational Site Number 642205
      • Sibiu, Romania, 550371
        • Investigational Site Number 642209
      • Targu Mures, Romania, 540142
        • Investigational Site Number 642207
      • Targu Mures, Romania, 540142
        • Investigational Site Number 642208
      • Timisoara, Romania, 300456
        • Investigational Site Number 642203
  • Russian Federation
      • Saint-Petersburg, Russian Federation, 190013
        • Investigational Site Number 643201
      • Saratov, Russian Federation, 410030
        • Investigational Site Number 643205
      • St-Petersburg, Russian Federation, 194354
        • Investigational Site Number 643203
      • St-Petersburg, Russian Federation, 195257
        • Investigational Site Number 643202
      • St. Petersburg, Russian Federation, 194358
        • Investigational Site Number 643204
  • Spain
      • Barcelona, Spain, 08035
        • Investigational Site Number 724201
      • Málaga, Spain, 29010
        • Investigational Site Number 724203
      • Palma De Mallorca, Spain, 07010
        • Investigational Site Number 724202
  • Turkey
      • Istanbul, Turkey, 34303
        • Investigational Site Number 792201
      • Istanbul, Turkey, 34890
        • Investigational Site Number 792202
      • Izmir, Turkey, 35100
        • Investigational Site Number 792204
      • Izmir, Turkey, 35340
        • Investigational Site Number 792203
  • United States
    • Alabama
      • Foley, Alabama, United States, 36535
        • Investigational Site Number 840217
      • Muscle Shoals, Alabama, United States, 35661
        • Investigational Site Number 840237
    • Arizona
      • Chandler, Arizona, United States
        • Investigational Site Number 840245
      • Phoenix, Arizona, United States, 85028
        • Investigational Site Number 840219
      • Phoenix, Arizona, United States, 85050
        • Investigational Site Number 840227
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Investigational Site Number 840212
    • California
      • El Cajon, California, United States, 92020
        • Investigational Site Number 840241
      • Fresno, California, United States, 93720
        • Investigational Site Number 840238
      • Greenbrae, California, United States, 94904
        • Investigational Site Number 840229
      • Huntington Beach, California, United States, 92648
        • Investigational Site Number 840231
      • Long Beach, California, United States, 90807
        • Investigational Site Number 840247
      • Los Angeles, California, United States, 90057
        • Investigational Site Number 840234
      • Northridge, California, United States, 91325
        • Investigational Site Number 840235
      • Palm Springs, California, United States, 92262
        • Investigational Site Number 840251
      • Santa Ana, California, United States, 92704
        • Investigational Site Number 840249
      • Temecula, California, United States, 92591
        • Investigational Site Number 840223
      • Tustin, California, United States, 92780
        • Investigational Site Number 840259
      • Walnut Creek, California, United States, 94598
        • Investigational Site Number 840240
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Investigational Site Number 840214
      • Miami, Florida, United States, 33176
        • Investigational Site Number 840246
      • New Port Richey, Florida, United States, 34652
        • Investigational Site Number 840226
      • Ocoee, Florida, United States, 34761
        • Investigational Site Number 840205
      • Palm Harbor, Florida, United States, 34684
        • Investigational Site Number 840206
      • Port Charlotte, Florida, United States, 33952
        • Investigational Site Number 840242
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Investigational Site Number 840253
      • Stockbridge, Georgia, United States, 30281
        • Investigational Site Number 840207
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Investigational Site Number 840248
    • Indiana
      • Avon, Indiana, United States, 46123
        • Investigational Site Number 840204
      • Evansville, Indiana, United States, 47714
        • Investigational Site Number 840257
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Investigational Site Number 840230
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Investigational Site Number 840239
    • Michigan
      • Troy, Michigan, United States, 48085
        • Investigational Site Number 840236
    • Nebraska
      • Lincoln, Nebraska, United States, 68521
        • Investigational Site Number 840216
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Investigational Site Number 840220
      • Las Vegas, Nevada, United States, 89148
        • Investigational Site Number 840233
    • New Jersey
      • Linden, New Jersey, United States
        • Investigational Site Number 840224
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Investigational Site Number 840232
      • Morehead City, North Carolina, United States, 28557
        • Investigational Site Number 840211
      • Morganton, North Carolina, United States, 28655
        • Investigational Site Number 840228
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Investigational Site Number 840225
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Investigational Site Number 840221
      • Dayton, Ohio, United States, 45439
        • Investigational Site Number 840255
    • Pennsylvania
      • Tipton, Pennsylvania, United States, 16684
        • Investigational Site Number 840250
      • Uniontown, Pennsylvania, United States, 15401
        • Investigational Site Number 840243
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Investigational Site Number 840208
      • Jackson, Tennessee, United States, 38305
        • Investigational Site Number 840215
    • Texas
      • Austin, Texas, United States, 78731
        • Investigational Site Number 840203
      • Dallas, Texas, United States, 75231
        • Investigational Site Number 840258
      • Dallas, Texas, United States, 75246
        • Investigational Site Number 840201
    • Washington
      • Renton, Washington, United States, 98055
        • Investigational Site Number 840222
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209-0996
        • Investigational Site Number 840209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Participants with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit.
  • Signed written informed consent.

Exclusion criteria:

  • At screening visit, age under legal age of adulthood.
  • HbA1c <6.5% or >10.0% at screening.
  • Diabetes other than T2DM.
  • Pregnancy and lactation.
  • Women of childbearing potential not protected by highly effective contraceptive method of birth control.
  • Use of insulin pump in the 6 months before screening visit.
  • Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an European Union (EU) approved insulin lispro and is allowed in those countries where it is marketed.
  • Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal.
  • Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists or other peptides) in the 6 months prior to screening visit.
  • Body mass index (BMI) >=40kg/m² at 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.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SAR342434
SAR342434 100 Unit/mL (U/mL) before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.
Drug: SAR342434
SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by subcutaneous (SC) injection, immediately (within 5 -10 minutes) before meals intake. Dose adjusted to achieve 2 hour post prandial 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 Names:
  • Lantus®
ACTIVE_COMPARATOR: Humalog
Humalog 100 U/mL before meals intake on top of QD Insulin Glargine, up to Week 26.
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 Names:
  • Lantus®
Drug: Humalog
Humalog 100 U/ml (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meals 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 hypoglycemia.
Other Names:
  • Insulin Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 6-month period and adequate contrasts at Week 26.
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26
Time Frame: Week 26
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Week 26
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 6-month period and adequate contrasts at Week 26.
Baseline, Week 26
Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
Time Frame: Baseline, Week 26
The 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. 7-point SMPGs were performed at least two times in a week before baseline, before visit Week 12 and before visit Week 26. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the 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 6-month period and adequate contrasts at Week 26.
Baseline, Week 26
Change in Post Prandial 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 postprandial glucose (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 6-month period and adequate contrasts at Week 26.
Baseline, Week 26
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)
Time Frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)
Percentage of participants with at least one treatment emergent hypoglycemia reported at any time of the day 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.
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)
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: 210 days)
Percentage of participants with hypersensitivity reactions and injection site reactions were reported.
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)
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: 210 days)
Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were participants 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 participants 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).
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Daily Insulin Dose From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 value.
Baseline, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (ESTIMATE)

November 19, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2018

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC13403
  • 2014-002844-42 (EUDRACT_NUMBER)
  • U1111-1156-4296 (UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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