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Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents (LixiLan-D)

Primary Purpose

Type 2 Diabetes Mellitus

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Insulin glargine/Lixisenatide

Insulin glargine (HOE901)

Background therapy

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion criteria :

Participants with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to the screening visit (signing of informed consent).
Uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin A1c (HbA1c) between 7.5% and 10% (inclusive).
Participants who were Hispanics of any race, non-Hispanic black/African Americans or non-Hispanic Asians. Note: Decision for ethnic/racial inclusion was made based on the participant's self-identification. Mixed-race participants must select 1 of the above-mentioned categories. If such selection could not be made, the candidate would be ineligible to participate in the study.
Participants who had been treated with any basal insulin (ie, glargine - U100 or U300, detemir, degludec, intermediate-acting [human Neutral Protamine Hagedorn (NPH]) for at least 6 months prior to Visit 1.
The basal insulin regimen (ie, type of insulin and time/frequency of the injection) had been stable for at least 3 months prior to Visit 1.
The basal insulin dose had been stable (defined as up to ±20% [1/5 of the dose] variability) for at least 2 months prior to Visit 1 within the following dose ranges:
15 to 50 units/day if HbA1c at Visit 1 is less than or equal to (<=)8.5%, and
15 to 40 units/day if HbA1c at Visit 1 is greater than (>)8.5%.
Participants receiving 1 or 2 of the following OAD drugs: metformin, pioglitazone/rosiglitazone, an sodium-glucose transport protein 2 (SGLT-2) inhibitor or a sulfonylurea (SU), at stable doses for at least 12 weeks prior to Visit 1.

Exclusion criteria:

Age <18 years of age at Visit 1.
A body mass index (BMI) <=20 or >40 kg/m^2 at Visit 1.
Fasting plasma glucose (FPG) >200 mg/dL (by central lab measurement) at Visit 1 (1-time repeat measurement before Visit 2 is permitted).
Type 1 DM or any diabetes other than T2DM.
Any use of OAD drugs other than those described in the inclusion criteria (e.g., but not limited to, glucagon like peptide-1 receptor agonist (GLP-1 RA), dipeptidyl peptidase 4 (DPP4) inhibitors) within 12 weeks prior Visit 1.
Use of any other type of insulin except for basal insulin (e.g., prandial or premixed insulin, insulin pump) within 6 months prior to Visit 1. Note: History of short-term treatment (i.e, <=10 days) with other insulin types due to intercurrent illness was permitted at the discretion of the Investigator.
Known history of discontinuation of treatment with a GLP-1 RA due to safety/tolerability reasons.
Use of systemic glucocorticoids for a total duration of >7 days within 12 weeks prior to Visit 1.
Initiation/change in type or dose of a weight loss drug within 12 weeks prior to Visit 1.

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Soliqua 100/33

Lantus

Arm Description

Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.

Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

Change in HbA1c was calculated by subtracting baseline value from Week 26 value.

Secondary Outcome Measures

Percentage of Participants Achieving HbA1c Target of <7% at Week 26

Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.

Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26

The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.

Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26

Change From Baseline in Daily Insulin Glargine Dose at Week 26

Change in daily dose was calculated by subtracting baseline value from Week 26 value.

Change From Baseline in Body Weight at Week 26

Change in body weight was calculated by subtracting baseline value from Week 26 value.

Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period

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 hypoglycemia with plasma glucose cut-off of <=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose <=70 mg/dL (3.9 mmol/L) and excluding plasma glucose <54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of <54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose <54 mg/dL (3.0 mmol/L) regardless of symptoms.

Full Information

NCT ID

NCT03434119

First Posted

February 9, 2018

Last Updated

March 21, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03434119

Brief Title

Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

Acronym

LixiLan-D

Official Title

A 26-week Randomized, Open-label, Active-controlled, 2-treatment Arm, Parallel Group Multi-center Study, Comparing the Efficacy and Safety of Soliqua™100/33 Versus Lantus® in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

("Trial terminated (recruitment delays)")

Study Start Date

February 20, 2018 (Actual)

Primary Completion Date

January 7, 2019 (Actual)

Study Completion Date

January 7, 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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c (HbA1c) change within the overall population. To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African Americans and non-Hispanic Asians). Secondary Objective: To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated. To assess the change in daily insulin glargine dose within each ethnic/racial subgroup. To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua 100/33 versus Lantus within each ethnic/racial subgroup.

Detailed Description

The study duration was approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days follow-up period.

6. Conditions and Keywords

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

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

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Soliqua 100/33

Arm Type

Experimental

Arm Description

Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.

Arm Title

Lantus

Arm Type

Active Comparator

Arm Description

Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.

Intervention Type

Drug

Intervention Name(s)

Insulin glargine/Lixisenatide

Other Intervention Name(s)

Soliqua 100/33, HOE901/AVE0010

Intervention Description

Insulin glargine (100 units per milliliter [U/mL]) and lixisenatide (33 micrograms per milliliter [mcg/mL]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter [mmol/L]) while avoiding hypoglycemia.

Intervention Type

Drug

Intervention Name(s)

Insulin glargine (HOE901)

Other Intervention Name(s)

Lantus, HOE901

Intervention Description

Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.

Intervention Type

Drug

Intervention Name(s)

Background therapy

Intervention Description

Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.

Primary Outcome Measure Information:

Title

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

Description

Change in HbA1c was calculated by subtracting baseline value from Week 26 value.

Time Frame

Baseline, Week 26

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving HbA1c Target of <7% at Week 26

Description

Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.

Time Frame

Week 26

Title

Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26

Description

The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.

Time Frame

Baseline, Week 26

Title

Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26

Time Frame

Baseline, Week 26

Title

Change From Baseline in Daily Insulin Glargine Dose at Week 26

Description

Change in daily dose was calculated by subtracting baseline value from Week 26 value.

Time Frame

Baseline, Week 26

Title

Change From Baseline in Body Weight at Week 26

Description

Change in body weight was calculated by subtracting baseline value from Week 26 value.

Time Frame

Baseline, Week 26

Title

Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period

Description

Time Frame

Baseline to Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Participants with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to the screening visit (signing of informed consent). Uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin A1c (HbA1c) between 7.5% and 10% (inclusive). Participants who were Hispanics of any race, non-Hispanic black/African Americans or non-Hispanic Asians. Note: Decision for ethnic/racial inclusion was made based on the participant's self-identification. Mixed-race participants must select 1 of the above-mentioned categories. If such selection could not be made, the candidate would be ineligible to participate in the study. Participants who had been treated with any basal insulin (ie, glargine - U100 or U300, detemir, degludec, intermediate-acting [human Neutral Protamine Hagedorn (NPH]) for at least 6 months prior to Visit 1. The basal insulin regimen (ie, type of insulin and time/frequency of the injection) had been stable for at least 3 months prior to Visit 1. The basal insulin dose had been stable (defined as up to ±20% [1/5 of the dose] variability) for at least 2 months prior to Visit 1 within the following dose ranges: 15 to 50 units/day if HbA1c at Visit 1 is less than or equal to (<=)8.5%, and 15 to 40 units/day if HbA1c at Visit 1 is greater than (>)8.5%. Participants receiving 1 or 2 of the following OAD drugs: metformin, pioglitazone/rosiglitazone, an sodium-glucose transport protein 2 (SGLT-2) inhibitor or a sulfonylurea (SU), at stable doses for at least 12 weeks prior to Visit 1. Exclusion criteria: Age <18 years of age at Visit 1. A body mass index (BMI) <=20 or >40 kg/m^2 at Visit 1. Fasting plasma glucose (FPG) >200 mg/dL (by central lab measurement) at Visit 1 (1-time repeat measurement before Visit 2 is permitted). Type 1 DM or any diabetes other than T2DM. Any use of OAD drugs other than those described in the inclusion criteria (e.g., but not limited to, glucagon like peptide-1 receptor agonist (GLP-1 RA), dipeptidyl peptidase 4 (DPP4) inhibitors) within 12 weeks prior Visit 1. Use of any other type of insulin except for basal insulin (e.g., prandial or premixed insulin, insulin pump) within 6 months prior to Visit 1. Note: History of short-term treatment (i.e, <=10 days) with other insulin types due to intercurrent illness was permitted at the discretion of the Investigator. Known history of discontinuation of treatment with a GLP-1 RA due to safety/tolerability reasons. Use of systemic glucocorticoids for a total duration of >7 days within 12 weeks prior to Visit 1. Initiation/change in type or dose of a weight loss drug within 12 weeks prior to Visit 1. The above information is not intended to contain all considerations relevant to a participants'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 8400072

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36106

Country

United States

Facility Name

Investigational Site Number 8400077

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72204

Country

United States

Facility Name

Investigational Site Number 8400095

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Investigational Site Number 8400013

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

Investigational Site Number 8400076

City

Anaheim

State/Province

California

ZIP/Postal Code

92801-4123

Country

United States

Facility Name

Investigational Site Number 8400052

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Investigational Site Number 8400069

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Investigational Site Number 8400060

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

Investigational Site Number 8400049

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

Country

United States

Facility Name

Investigational Site Number 8400078

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

Investigational Site Number 8400047

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Investigational Site Number 8400066

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Investigational Site Number 8400050

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Investigational Site Number 8400092

City

Huntington Park

State/Province

California

ZIP/Postal Code

90255

Country

United States

Facility Name

Investigational Site Number 8400015

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Investigational Site Number 8400011

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 8400301

City

Los Angeles

State/Province

California

ZIP/Postal Code

90094

Country

United States

Facility Name

Investigational Site Number 8400302

City

Los Angeles

State/Province

California

ZIP/Postal Code

90094

Country

United States

Facility Name

Investigational Site Number 8400303

City

Los Angeles

State/Province

California

ZIP/Postal Code

90094

Country

United States

Facility Name

Investigational Site Number 8400304

City

Los Angeles

State/Province

California

ZIP/Postal Code

90094

Country

United States

Facility Name

Investigational Site Number 8400006

City

Los Gatos

State/Province

California

ZIP/Postal Code

95032

Country

United States

Facility Name

Investigational Site Number 8400048

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Facility Name

Investigational Site Number 8400053

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Investigational Site Number 8400084

City

Pomona

State/Province

California

ZIP/Postal Code

91766

Country

United States

Facility Name

Investigational Site Number 8400081

City

Pomona

State/Province

California

ZIP/Postal Code

91767

Country

United States

Facility Name

Investigational Site Number 8400042

City

Rancho Cucamonga

State/Province

California

ZIP/Postal Code

91730

Country

United States

Facility Name

Investigational Site Number 8400063

City

San Carlos

State/Province

California

ZIP/Postal Code

94070

Country

United States

Facility Name

Investigational Site Number 8400091

City

San Diego

State/Province

California

ZIP/Postal Code

92114

Country

United States

Facility Name

Investigational Site Number 8400086

City

San Jose

State/Province

California

ZIP/Postal Code

95148

Country

United States

Facility Name

Investigational Site Number 8400074

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Investigational Site Number 8400037

City

Temecula

State/Province

California

ZIP/Postal Code

92591

Country

United States

Facility Name

Investigational Site Number 8400087

City

Vallejo

State/Province

California

ZIP/Postal Code

94592

Country

United States

Facility Name

Investigational Site Number 8400024

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

Investigational Site Number 8400007

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Investigational Site Number 8400054

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Investigational Site Number 8400023

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06517

Country

United States

Facility Name

Investigational Site Number 8400041

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32653

Country

United States

Facility Name

Investigational Site Number 8400075

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Investigational Site Number 8400016

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Investigational Site Number 8400036

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Investigational Site Number 8400017

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Investigational Site Number 8400014

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 8400028

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Investigational Site Number 8400097

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

00000

Country

United States

Facility Name

Investigational Site Number 8400035

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Investigational Site Number 8400094

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Investigational Site Number 8400025

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

Investigational Site Number 8400051

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30310

Country

United States

Facility Name

Investigational Site Number 8400093

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Investigational Site Number 8400005

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406-2675

Country

United States

Facility Name

Investigational Site Number 8400038

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Investigational Site Number 8400088

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Investigational Site Number 8400031

City

Des Plaines

State/Province

Illinois

ZIP/Postal Code

60018

Country

United States

Facility Name

Investigational Site Number 8400064

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Investigational Site Number 8400057

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

Investigational Site Number 8400030

City

Gretna

State/Province

Louisiana

ZIP/Postal Code

70053

Country

United States

Facility Name

Investigational Site Number 8400009

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70124

Country

United States

Facility Name

Investigational Site Number 8400065

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Investigational Site Number 8400061

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Investigational Site Number 8400079

City

Chelsea

State/Province

Michigan

ZIP/Postal Code

48118

Country

United States

Facility Name

Investigational Site Number 8400001

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Investigational Site Number 8400012

City

Flint

State/Province

Michigan

ZIP/Postal Code

48532-3447

Country

United States

Facility Name

Investigational Site Number 8400090

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89117

Country

United States

Facility Name

Investigational Site Number 8400082

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Investigational Site Number 8400018

City

Linden

State/Province

New Jersey

ZIP/Postal Code

07036

Country

United States

Facility Name

Investigational Site Number 8400003

City

Bronx

State/Province

New York

ZIP/Postal Code

10455

Country

United States

Facility Name

Investigational Site Number 8400062

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Investigational Site Number 8400043

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Investigational Site Number 8400021

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 8400040

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76132

Country

United States

Facility Name

Investigational Site Number 8400045

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

Investigational Site Number 8400002

City

Humble

State/Province

Texas

ZIP/Postal Code

77338

Country

United States

Facility Name

Investigational Site Number 8400039

City

Kerrville

State/Province

Texas

ZIP/Postal Code

78028

Country

United States

Facility Name

Investigational Site Number 8400096

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

Investigational Site Number 8400027

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78228

Country

United States

Facility Name

Investigational Site Number 8400083

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78230

Country

United States

Facility Name

Investigational Site Number 8400008

City

Splendora

State/Province

Texas

ZIP/Postal Code

77372

Country

United States

Facility Name

Investigational Site Number 8400055

City

Spring

State/Province

Texas

ZIP/Postal Code

77379

Country

United States

Facility Name

Investigational Site Number 8400070

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

Investigational Site Number 8400085

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Investigational Site Number 8400059

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Investigational Site Number 8400044

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110

Country

United States

Facility Name

Investigational Site Number 8400068

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

Investigational Site Number 8400033

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

Investigational Site Number 8400029

City

Richland

State/Province

Washington

ZIP/Postal Code

99352

Country

United States

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

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Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

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Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents (LixiLan-D)

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

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