Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02273180
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 507
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR342434 SAR342434 SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52. SAR342434 Insulin glargine HOE901 SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52. Humalog Insulin glargine HOE901 Humalog before meals intake on top of QD Insulin Glargine, up to Week 52. Humalog Humalog Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Week 26 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
Name Time Method Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26 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.
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 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.
Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 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.
Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions 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.
Percentage of Participants With HbA1c <7.0% at Week 26 Week 26 Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year 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.
Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs) 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).
Trial Locations
- Locations (89)
Investigational Site Number 348003
ššŗBudapest, Hungary
Investigational Site Number 348011
ššŗBudapest, Hungary
Investigational Site Number 616002
šµš±Warszawa, Poland
Investigational Site Number 616004
šµš±Zabrze, Poland
Investigational Site Number 724005
šŖšøMĆ”laga, Spain
Investigational Site Number 643002
š·šŗSaratov, Russian Federation
Investigational Site Number 643004
š·šŗSt-Petersburg, Russian Federation
Investigational Site Number 724001
šŖšøCĆ”ceres, Spain
Investigational Site Number 643006
š·šŗSamara, Russian Federation
Investigational Site Number 724003
šŖšøSabadell, Spain
Investigational Site Number 724004
šŖšøLĆ©rida, Spain
Investigational Site Number 643001
š·šŗSt-Petersburg, Russian Federation
Investigational Site Number 724002
šŖšøA CoruƱa, Spain
Investigational Site Number 840039
šŗšøFresno, California, United States
Investigational Site Number 840005
šŗšøBradenton, Florida, United States
Investigational Site Number 840042
šŗšøMiami, Florida, United States
Investigational Site Number 840031
šŗšøPort Charlotte, Florida, United States
Investigational Site Number 840020
šŗšøIdaho Falls, Idaho, United States
Investigational Site Number 840038
šŗšøBaltimore, Maryland, United States
Investigational Site Number 840060
šŗšøGreat Falls, Montana, United States
Investigational Site Number 840051
šŗšøGreenville, North Carolina, United States
Investigational Site Number 840041
šŗšøDallas, Texas, United States
Investigational Site Number 840061
šŗšøMiami Lakes, Florida, United States
Investigational Site Number 840029
šŗšøDallas, Texas, United States
Investigational Site Number 840034
šŗšøDallas, Texas, United States
Investigational Site Number 840049
šŗšøTucson, Arizona, United States
Investigational Site Number 840048
šŗšøChula Vista, California, United States
Investigational Site Number 840016
šŗšøBell Gardens, California, United States
Investigational Site Number 840046
šŗšøConcord, California, United States
Investigational Site Number 840028
šŗšøLa Jolla, California, United States
Investigational Site Number 840022
šŗšøVentura, California, United States
Investigational Site Number 840003
šŗšøDenver, Colorado, United States
Investigational Site Number 840037
šŗšøDenver, Colorado, United States
Investigational Site Number 840057
šŗšøMiami Lakes, Florida, United States
Investigational Site Number 840050
šŗšøMiami, Florida, United States
Investigational Site Number 840036
šŗšøAtlanta, Georgia, United States
Investigational Site Number 840013
šŗšøNorth Miami Beach, Florida, United States
Investigational Site Number 840019
šŗšøChicago, Illinois, United States
Investigational Site Number 840045
šŗšøRoswell, Georgia, United States
Investigational Site Number 840033
šŗšøChicago, Illinois, United States
Investigational Site Number 840004
šŗšøDes Moines, Iowa, United States
Investigational Site Number 840012
šŗšøMcHenry, Illinois, United States
Investigational Site Number 840043
šŗšøMarrero, Louisiana, United States
Investigational Site Number 840021
šŗšøMetairie, Louisiana, United States
Investigational Site Number 840014
šŗšøRockville, Maryland, United States
Investigational Site Number 840026
šŗšøOmaha, Nebraska, United States
Investigational Site Number 840040
šŗšøOmaha, Nebraska, United States
Investigational Site Number 840015
šŗšøAlbuquerque, New Mexico, United States
Investigational Site Number 840059
šŗšøMineola, New York, United States
Investigational Site Number 840054
šŗšøAlbuquerque, New Mexico, United States
Investigational Site Number 840030
šŗšøBurlington, North Carolina, United States
Investigational Site Number 840062
šŗšøWilmington, North Carolina, United States
Investigational Site Number 840007
šŗšøDakota Dunes, South Dakota, United States
Investigational Site Number 840027
šŗšøRapid City, South Dakota, United States
Investigational Site Number 840018
šŗšøGallipolis, Ohio, United States
Investigational Site Number 840002
šŗšøHouston, Texas, United States
Investigational Site Number 840011
šŗšøChesapeake, Virginia, United States
Investigational Site Number 840023
šŗšøTacoma, Washington, United States
Investigational Site Number 250002
š«š·Corbeil Essonnes, France
Investigational Site Number 250003
š«š·Montpellier Cedex 5, France
Investigational Site Number 250001
š«š·Vandoeuvre Les Nancy, France
Investigational Site Number 250005
š«š·Mantes La Jolie, France
Investigational Site Number 276001
š©šŖBerlin, Germany
Investigational Site Number 276006
š©šŖHannover, Germany
Investigational Site Number 276004
š©šŖDortmund, Germany
Investigational Site Number 276002
š©šŖHeidelberg, Germany
Investigational Site Number 276003
š©šŖNeumĆ¼nster, Germany
Investigational Site Number 276007
š©šŖPotsdam, Germany
Investigational Site Number 348002
ššŗBudapest, Hungary
Investigational Site Number 276005
š©šŖSulzbach-Rosenberg, Germany
Investigational Site Number 348005
ššŗBudapest, Hungary
Investigational Site Number 392003
šÆšµHigashiosaka-Shi, Japan
Investigational Site Number 392004
šÆšµIzumisano-Shi, Japan
Investigational Site Number 348007
ššŗDebrecen, Hungary
Investigational Site Number 348010
ššŗBudapest, Hungary
Investigational Site Number 392006
šÆšµChuo-Ku, Japan
Investigational Site Number 392005
šÆšµKamakura-Shi, Japan
Investigational Site Number 348001
ššŗBudapest, Hungary
Investigational Site Number 616001
šµš±Poznan, Poland
Investigational Site Number 392001
šÆšµShinjuku-Ku, Japan
Investigational Site Number 616005
šµš±Krakow, Poland
Investigational Site Number 392002
šÆšµYamato-Shi, Japan
Investigational Site Number 616003
šµš±Szczecin, Poland
Investigational Site Number 643003
š·šŗMoscow, Russian Federation
Investigational Site Number 643005
š·šŗSt-Petersburg, Russian Federation
Investigational Site Number 643007
š·šŗTomsk, Russian Federation
Investigational Site Number 840009
šŗšøMilwaukee, Wisconsin, United States
Investigational Site Number 840006
šŗšøNew Port Richey, Florida, United States
Investigational Site Number 276008
š©šŖPirna, Germany