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Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (GEMELLI1)

Primary Purpose

Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Insulin aspart

NovoLog/NovoRapid

Insulin glargine (HOE901)

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with
NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening visit AND
insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin detemir (Levemir®) in the last 12 months prior to screening visit.

Exclusion criteria:

At screening visit, age under legal age of adulthood.
HbA1c <7.0% or greater than (>) 10% at screening.
Less than 1 year on continuous insulin treatment.
Use of insulin pump in the last 3 months before screening visit.
Participants with incomplete baseline 7-point SMPG profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3.
Participants with T1DM: Use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening.
Participants with T2DM:
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months before screening visit.
- Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months before screening visit (sulfonylureas was discontinued at baseline).
At screening visit, body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter square (kg/m^2) in participants with T1DM and >=40 kg/m^2 in participants with T2DM.
Use of insulin other than:
- insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as part of a multiple injection regimen in the last 6 months before screening visit, OR
- insulin detemir 100 U/mL in the 12 months before screening visit and NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before screening visit as part of a multiple injection regimen.
Status post pancreatectomy.
Status post pancreas and/or islet cell transplantation.
Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before screening visit.
History of severe hypoglycemia requiring Emergency Room admission or hospitalization in the last 3 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.
Pregnant or breastfeeding women.
Women of childbearing potential not protected by highly effective method(s) of birth control.

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAR341402

NovoLog/NovoRapid

Arm Description

SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.

NovoLog/NovoRapid SC, before meals intake on top of QD Insulin Glargine, up to Week 52.

Outcomes

Primary Outcome Measures

Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26

All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae).

Secondary Outcome Measures

Change in HbA1c From Baseline to Week 52

All values up to Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 52 value. Missing changes at Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae).

Percentage of Participants With HbA1c <7% at Week 26 and Week 52

Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders.

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52

All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in FPG at Week 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).

Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52

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 the week before a visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in mean 24-hour plasma glucose concentration at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).

Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52

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 the average across profiles performed in the week before the visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in PPG excursions at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).

Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point

7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 26, and Week 52): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.

Number of Participants With at Least One Hypoglycemic Event

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL).

Number of Hypoglycemia Events Per Participant-Year

Number of hypoglycemia events (any, severe and documented [both thresholds]) 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, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL).

Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions

Participants with at least one treatment-emergent adverse event linked to hypersensitivity reaction and injection site reaction regardless of relationship to IMP during the main 6-month and the 12-month on-treatment periods was assessed and reported.

Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample

Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence).

Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)

AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) 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). 2) 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). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs.

Full Information

NCT ID

NCT03211858

First Posted

July 6, 2017

Last Updated

March 15, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03211858

Brief Title

Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine

Acronym

GEMELLI1

Official Title

Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

August 2, 2017 (Actual)

Primary Completion Date

July 16, 2018 (Actual)

Study Completion Date

January 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®. Secondary Objectives: To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study. To assess the relationship of AIAs with efficacy and safety. To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of participants reaching HbA1c lesser than (<) 7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c). To assess safety of SAR341402 and NovoLog/NovoRapid.

Detailed Description

The study consisted of a 2-week screening period, a 26-week treatment period, a 26-week comparative safety extension period, and a 1-day follow-up period. The maximum study duration was 54 weeks per participant and a 1 day safety follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

597 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR341402

Arm Type

Experimental

Arm Description

SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.

Arm Title

NovoLog/NovoRapid

Arm Type

Active Comparator

Arm Description

NovoLog/NovoRapid SC, before meals intake on top of QD Insulin Glargine, up to Week 52.

Intervention Type

Drug

Intervention Name(s)

Insulin aspart

Intervention Description

SAR341402 100 units per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG <10 millimoles/liter [mmol/L] [<180 milligram/deciliter {mg/dL}]) while avoiding hypoglycemia.

Intervention Type

Drug

Intervention Name(s)

NovoLog/NovoRapid

Other Intervention Name(s)

Insulin aspart

Intervention Description

NovoLog/NovoRapid 100 U/mL (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG <10 mmol/L [<180 mg/dL]) while avoiding hypoglycemia.

Intervention Type

Drug

Intervention Name(s)

Insulin glargine (HOE901)

Other Intervention Name(s)

Lantus

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26

Description

Time Frame

Baseline, Week 26

Secondary Outcome Measure Information:

Title

Change in HbA1c From Baseline to Week 52

Description

Time Frame

Baseline, Week 52

Title

Percentage of Participants With HbA1c <7% at Week 26 and Week 52

Description

Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders.

Time Frame

Week 26 and Week 52

Title

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52

Description

Time Frame

Baseline, Week 26, and Week 52

Title

Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52

Description

Time Frame

Baseline, Week 26, and Week 52

Title

Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52

Description

Time Frame

Baseline, Week 26, and Week 52

Title

Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point

Description

Time Frame

Baseline, Week 26, and Week 52

Title

Number of Participants With at Least One Hypoglycemic Event

Description

Time Frame

From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

Title

Number of Hypoglycemia Events Per Participant-Year

Description

Time Frame

Title

Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions

Description

Time Frame

From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

Title

Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample

Description

Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence).

Time Frame

Title

Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)

Description

Time Frame

Other Pre-specified Outcome Measures:

Title

Change in Glycated Hemoglobin A1c From Baseline to Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

Description

All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c at Week 26 and Week 52 was calculated by subtracting baseline value from Week 26 and Week 52 value, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae).

Time Frame

Baseline, Week 26 and Week 52

Title

Number of Participants With at Least One Hypoglycemic Event: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

Description

Time Frame

Title

Number of Participants With Adverse Events: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

Description

Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during the main 6-month or 12-month on-treatment periods.

Time Frame

From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

Title

Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs): Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

Description

AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) 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. 2) 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). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. Data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog).

Time Frame

Title

Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52

Description

Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit.

Time Frame

Baseline, Day 1, Week 26 and Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening visit AND insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin detemir (Levemir®) in the last 12 months prior to screening visit. Exclusion criteria: At screening visit, age under legal age of adulthood. HbA1c <7.0% or greater than (>) 10% at screening. Less than 1 year on continuous insulin treatment. Use of insulin pump in the last 3 months before screening visit. Participants with incomplete baseline 7-point SMPG profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3. Participants with T1DM: Use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening. Participants with T2DM: Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months before screening visit. Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months before screening visit (sulfonylureas was discontinued at baseline). At screening visit, body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter square (kg/m^2) in participants with T1DM and >=40 kg/m^2 in participants with T2DM. Use of insulin other than: insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as part of a multiple injection regimen in the last 6 months before screening visit, OR insulin detemir 100 U/mL in the 12 months before screening visit and NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before screening visit as part of a multiple injection regimen. Status post pancreatectomy. Status post pancreas and/or islet cell transplantation. Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before screening visit. History of severe hypoglycemia requiring Emergency Room admission or hospitalization in the last 3 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. Pregnant or breastfeeding women. Women of childbearing potential not protected by highly effective method(s) of birth control. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 8400040

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

Investigational Site Number 8400012

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Investigational Site Number 8400002

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Investigational Site Number 8400030

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Investigational Site Number 8400004

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Investigational Site Number 8400014

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Investigational Site Number 8400043

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 8400036

City

Pomona

State/Province

California

ZIP/Postal Code

91766

Country

United States

Facility Name

Investigational Site Number 8400011

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

Investigational Site Number 8400013

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Investigational Site Number 8400037

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Investigational Site Number 8400018

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Investigational Site Number 8400031

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Investigational Site Number 8400027

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 8400007

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Investigational Site Number 8400022

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Investigational Site Number 8400032

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Investigational Site Number 8400038

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Investigational Site Number 8400005

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Investigational Site Number 8400041

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Investigational Site Number 8400015

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852-4267

Country

United States

Facility Name

Investigational Site Number 8400042

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02453

Country

United States

Facility Name

Investigational Site Number 8400019

City

Flint

State/Province

Michigan

ZIP/Postal Code

48532-3447

Country

United States

Facility Name

Investigational Site Number 8400003

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Investigational Site Number 8400024

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Investigational Site Number 8400028

City

New York

State/Province

New York

ZIP/Postal Code

10001

Country

United States

Facility Name

Investigational Site Number 8400025

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Investigational Site Number 8400010

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Investigational Site Number 8400023

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

Facility Name

Investigational Site Number 8400029

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Facility Name

Investigational Site Number 8400033

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Investigational Site Number 8400044

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Investigational Site Number 8400009

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 8400035

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 8400021

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Investigational Site Number 8400017

City

Houston

State/Province

Texas

ZIP/Postal Code

77043

Country

United States

Facility Name

Investigational Site Number 8400001

City

Houston

State/Province

Texas

ZIP/Postal Code

77079

Country

United States

Facility Name

Investigational Site Number 8400020

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

Investigational Site Number 8400016

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75149

Country

United States

Facility Name

Investigational Site Number 8400034

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Investigational Site Number 8400008

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

Investigational Site Number 8400039

City

Bridgeport

State/Province

West Virginia

ZIP/Postal Code

26330

Country

United States

Facility Name

Investigational Site Number 2460006

City

Jyväskylä

ZIP/Postal Code

40100

Country

Finland

Facility Name

Investigational Site Number 2460002

City

Kuopio

ZIP/Postal Code

70100

Country

Finland

Facility Name

Investigational Site Number 2460004

City

Pori

ZIP/Postal Code

28500

Country

Finland

Facility Name

Investigational Site Number 2460003

City

Seinäjoki

ZIP/Postal Code

60100

Country

Finland

Facility Name

Investigational Site Number 2760001

City

Berlin

ZIP/Postal Code

10115

Country

Germany

Facility Name

Investigational Site Number 2760006

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Investigational Site Number 2760004

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

Investigational Site Number 2760005

City

Oldenburg In Holstein

ZIP/Postal Code

23758

Country

Germany

Facility Name

Investigational Site Number 2760002

City

Pirna

ZIP/Postal Code

01796

Country

Germany

Facility Name

Investigational Site Number 3480012

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Investigational Site Number 3480011

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 3480008

City

Budapest

ZIP/Postal Code

1042

Country

Hungary

Facility Name

Investigational Site Number 3480001

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Investigational Site Number 3480005

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Investigational Site Number 3480004

City

Budapest

ZIP/Postal Code

1139

Country

Hungary

Facility Name

Investigational Site Number 3480007

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

Facility Name

Investigational Site Number 3480003

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

Investigational Site Number 3480010

City

Nyíregyháza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Investigational Site Number 3480009

City

Szentendre

ZIP/Postal Code

2000

Country

Hungary

Facility Name

Investigational Site Number 3920009

City

Fukuyama-Shi

Country

Japan

Facility Name

Investigational Site Number 3920008

City

Higashiosaka-Shi

Country

Japan

Facility Name

Investigational Site Number 3920007

City

Kashiwara-Shi

Country

Japan

Facility Name

Investigational Site Number 3920001

City

Koriyama-Shi

Country

Japan

Facility Name

Investigational Site Number 3920005

City

Kumamoto-Shi

Country

Japan

Facility Name

Investigational Site Number 3920003

City

Mito-Shi

Country

Japan

Facility Name

Investigational Site Number 3920010

City

Osaka-Shi

Country

Japan

Facility Name

Investigational Site Number 3920002

City

Sagamihara-Shi

Country

Japan

Facility Name

Investigational Site Number 3920004

City

Shinjuku-Ku

Country

Japan

Facility Name

Investigational Site Number 3920006

City

Ushiku-Shi

Country

Japan

Facility Name

Investigational Site Number 6160004

City

Bialystok

ZIP/Postal Code

15-435

Country

Poland

Facility Name

Investigational Site Number 6160003

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Investigational Site Number 6160005

City

Krakow

ZIP/Postal Code

31-548

Country

Poland

Facility Name

Investigational Site Number 6160007

City

Lublin

ZIP/Postal Code

20-538

Country

Poland

Facility Name

Investigational Site Number 6160006

City

Nowy Sacz

ZIP/Postal Code

33-300

Country

Poland

Facility Name

Investigational Site Number 6160001

City

Poznan

ZIP/Postal Code

60-834

Country

Poland

Facility Name

Investigational Site Number 6160002

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Investigational Site Number 6430002

City

Samara

ZIP/Postal Code

443041

Country

Russian Federation

Facility Name

Investigational Site Number 6430003

City

Saratov

ZIP/Postal Code

410030

Country

Russian Federation

Facility Name

Investigational Site Number 6430001

City

St. Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Investigational Site Number 6430004

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Citations:

PubMed Identifier

31804851

Citation

Garg SK, Wernicke-Panten K, Wardecki M, Kramer D, Delalande F, Franek E, Sadeharju K, Monchamp T, Mukherjee B, Shah VN. Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1). Diabetes Technol Ther. 2020 Feb;22(2):85-95. doi: 10.1089/dia.2019.0382.

Results Reference

background

PubMed Identifier

32068436

Citation

Garg SK, Wernicke-Panten K, Wardecki M, Kramer D, Delalande F, Franek E, Sadeharju K, Monchamp T, Miossec P, Mukherjee B, Shah VN. Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial. Diabetes Technol Ther. 2020 Jul;22(7):516-526. doi: 10.1089/dia.2020.0008. Epub 2020 Mar 31.

Results Reference

background

PubMed Identifier

33432547

Citation

Shah VN, Franek E, Wernicke-Panten K, Pierre S, Mukherjee B, Sadeharju K. Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin. Diabetes Ther. 2021 Feb;12(2):557-568. doi: 10.1007/s13300-020-00992-x. Epub 2021 Jan 11.

Results Reference

derived

Learn more about this trial

Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine

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Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (GEMELLI1)

Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial