Back to results

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients (GetGoal-Duo-2)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Lixisenatide (AVE0010)

Insulin glulisine QD

Insulin glulisine TID

Insulin Glargine (Mandatory background drug)

Metformin (Background drug)

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

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

Inclusion criteria :

Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1).
Participants treated with basal insulin for at least 6 months.
Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1.
Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria:

At screening: age < legal age of majority.
At screening, HbA1c: <7.5% and >10.0% for participants treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide.
Women of childbearing potential with no effective contraceptive method, pregnancy or lactation.
Type 1 diabetes mellitus.
Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.
At screening, Body Mass Index (BMI) ≤20 or >40 kg/m^2.
Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
At screening resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.
Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposed to MTC (e.g. multiple endocrine neoplasia syndromes).
Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
At screening, amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN).
At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
At screening calcitonin ≥20 pg/ml (5.9 pmol/L).

Exclusion Criteria for randomization at the end of the screening period before randomization:

HbA1c <7.0% or >9.0%.
7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).
Amylase and/or lipase >3 times ULN.

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 3

Arm Type

Experimental

Active Comparator

Arm Label

Lixisenatide

Insulin Glulisine QD

Insulin Glulisine TID

Arm Description

Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.

Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.

Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to Week 26

Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.

Change in Body Weight From Baseline to Week 26

Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID. Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.

Secondary Outcome Measures

Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26

The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.

Percentage of Participants With no Weight Gain at Week 26

The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.

Change in Average 7-point SMPG Profiles From Baseline to Week 26

Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.

Change in FPG From Baseline to Week 26

Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.

Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)

The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.

Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)

Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.

Change in Insulin Glargine Dose From Baseline to Week 26

Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.

Insulin Glulisine Dose at Week 26

The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.

Total Insulin Dose at Week 26

The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9.

Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.

Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period

The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.

Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26

Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period

The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.

Full Information

NCT ID

NCT01768559

First Posted

January 11, 2013

Last Updated

November 4, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01768559

Brief Title

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

Acronym

GetGoal-Duo-2

Official Title

A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: - To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: - To compare the treatments/regimens on: The percentage of participants reaching the target of HbA1c <7% or ≤6.5%, Body weight, Self-Monitored Glucose profiles, Fasting Plasma Glucose (FPG), Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants), Daily doses of insulins, Safety and tolerability.

Detailed Description

Approximately 41 weeks including a 26 week treatment period.

6. Conditions and Keywords

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

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

894 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lixisenatide

Arm Type

Experimental

Arm Description

Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.

Arm Title

Insulin Glulisine QD

Arm Type

Active Comparator

Arm Description

Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.

Arm Title

Insulin Glulisine TID

Arm Type

Active Comparator

Arm Description

Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.

Intervention Type

Drug

Intervention Name(s)

Lixisenatide (AVE0010)

Other Intervention Name(s)

Lyxumia®, Device: Disposable self-injector prefilled pen (Delta 14®)

Intervention Description

Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner.

Intervention Type

Drug

Intervention Name(s)

Insulin glulisine QD

Other Intervention Name(s)

HMR1964, Device: Disposable self-injector prefilled pen (Apidra® Solostar®)

Intervention Description

Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value >5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner).

Intervention Type

Drug

Intervention Name(s)

Insulin glulisine TID

Other Intervention Name(s)

HMR1964, Device: Disposable self-injector prefilled pen (Apidra® Solostar®)

Intervention Description

Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value >5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner).

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine (Mandatory background drug)

Other Intervention Name(s)

Device: Disposable self-injector prefilled pen (Lantus® Solostar®)

Intervention Description

Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).

Intervention Type

Drug

Intervention Name(s)

Metformin (Background drug)

Intervention Description

Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.

Primary Outcome Measure Information:

Title

Change in HbA1c From Baseline to Week 26

Description

Time Frame

Baseline, Week 26

Title

Change in Body Weight From Baseline to Week 26

Description

Time Frame

Baseline, Week 26

Secondary Outcome Measure Information:

Title

Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26

Description

The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.

Time Frame

Week 26

Title

Percentage of Participants With no Weight Gain at Week 26

Description

The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.

Time Frame

Week 26

Title

Change in Average 7-point SMPG Profiles From Baseline to Week 26

Description

Time Frame

Baseline, Week 26

Title

Change in FPG From Baseline to Week 26

Description

Time Frame

Baseline, Week 26

Title

Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)

Description

Time Frame

Baseline, Week 26

Title

Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)

Description

Time Frame

Baseline, Week 26

Title

Change in Insulin Glargine Dose From Baseline to Week 26

Description

Time Frame

Baseline, Week 26

Title

Insulin Glulisine Dose at Week 26

Description

The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.

Time Frame

Week 26

Title

Total Insulin Dose at Week 26

Description

Time Frame

Week 26

Title

Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia

Description

Time Frame

First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)

Title

Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period

Description

Time Frame

Week 26

Title

Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26

Description

Time Frame

Week 26

Title

Description

Time Frame

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 diagnosed at least 1 year before screening visit (V1). Participants treated with basal insulin for at least 6 months. Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1. Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1. Exclusion criteria: At screening: age < legal age of majority. At screening, HbA1c: <7.5% and >10.0% for participants treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide. Women of childbearing potential with no effective contraceptive method, pregnancy or lactation. Type 1 diabetes mellitus. Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening. Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness. Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy. At screening, Body Mass Index (BMI) ≤20 or >40 kg/m^2. Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening. Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. At screening resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg. Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposed to MTC (e.g. multiple endocrine neoplasia syndromes). Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide. Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. At screening, amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN). At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN. At screening calcitonin ≥20 pg/ml (5.9 pmol/L). Exclusion Criteria for randomization at the end of the screening period before randomization: HbA1c <7.0% or >9.0%. 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L). Amylase and/or lipase >3 times ULN. 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 840043

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Investigational Site Number 840042

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Investigational Site Number 840003

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Investigational Site Number 840031

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Investigational Site Number 840005

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Investigational Site Number 840057

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Investigational Site Number 840035

City

Santa Ana

State/Province

California

ZIP/Postal Code

92704

Country

United States

Facility Name

Investigational Site Number 840002

City

Temecula

State/Province

California

ZIP/Postal Code

92591

Country

United States

Facility Name

Investigational Site Number 840037

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Investigational Site Number 840023

City

West Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Investigational Site Number 840041

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Investigational Site Number 840012

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Investigational Site Number 840061

City

Miami

State/Province

Florida

ZIP/Postal Code

33142

Country

United States

Facility Name

Investigational Site Number 840045

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30045

Country

United States

Facility Name

Investigational Site Number 840036

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83686

Country

United States

Facility Name

Investigational Site Number 840024

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Investigational Site Number 840009

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Investigational Site Number 840004

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Investigational Site Number 840055

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Investigational Site Number 840027

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Investigational Site Number 840006

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Investigational Site Number 840047

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Investigational Site Number 840056

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Investigational Site Number 840022

City

Marrero

State/Province

Louisiana

ZIP/Postal Code

70072

Country

United States

Facility Name

Investigational Site Number 840016

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Investigational Site Number 840017

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Investigational Site Number 840025

City

Buckley

State/Province

Michigan

ZIP/Postal Code

49620

Country

United States

Facility Name

Investigational Site Number 840048

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48124

Country

United States

Facility Name

Investigational Site Number 840026

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49048

Country

United States

Facility Name

Investigational Site Number 840049

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Investigational Site Number 840029

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Investigational Site Number 840060

City

Smithtown

State/Province

New York

ZIP/Postal Code

11787

Country

United States

Facility Name

Investigational Site Number 840030

City

Staten Island

State/Province

New York

ZIP/Postal Code

10301-3914

Country

United States

Facility Name

Investigational Site Number 840011

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Investigational Site Number 840028

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Investigational Site Number 840007

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Investigational Site Number 840021

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Investigational Site Number 840052

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

Investigational Site Number 840032

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Investigational Site Number 840033

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Investigational Site Number 840034

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Investigational Site Number 840001

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 840020

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Investigational Site Number 840018

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Investigational Site Number 840015

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

Investigational Site Number 840010

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53217

Country

United States

Facility Name

Investigational Site Number 124008

City

Brampton

ZIP/Postal Code

L6R 3J5

Country

Canada

Facility Name

Investigational Site Number 124015

City

Burlington

ZIP/Postal Code

L7M 4Y1

Country

Canada

Facility Name

Investigational Site Number 124018

City

Chatham

ZIP/Postal Code

N7L 1C1

Country

Canada

Facility Name

Investigational Site Number 124004

City

Coquitlam

ZIP/Postal Code

V3K 3P4

Country

Canada

Facility Name

Investigational Site Number 124016

City

Etobicoke

ZIP/Postal Code

M9R 4E1

Country

Canada

Facility Name

Investigational Site Number 124014

City

Hamilton

ZIP/Postal Code

L8L 5G8

Country

Canada

Facility Name

Investigational Site Number 124020

City

Montreal

ZIP/Postal Code

H1Y 3L1

Country

Canada

Facility Name

Investigational Site Number 124011

City

Montreal

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Investigational Site Number 124017

City

Newmarket

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Investigational Site Number 124021

City

Quebec

ZIP/Postal Code

G1N 4V3

Country

Canada

Facility Name

Investigational Site Number 124003

City

Red Deer

ZIP/Postal Code

T4N 6V7

Country

Canada

Facility Name

Investigational Site Number 124002

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Investigational Site Number 124012

City

St-Romuald

ZIP/Postal Code

G6W 5M6

Country

Canada

Facility Name

Investigational Site Number 124001

City

Toronto

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Investigational Site Number 124010

City

Toronto

ZIP/Postal Code

M5C 2T2

Country

Canada

Facility Name

Investigational Site Number 124005

City

Vancouver

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Investigational Site Number 124006

City

Victoria

ZIP/Postal Code

V8V 4A1

Country

Canada

Facility Name

Investigational Site Number 124007

City

Winnipeg

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

Investigational Site Number 152103

City

Santiago

ZIP/Postal Code

7500010

Country

Chile

Facility Name

Investigational Site Number 152107

City

Santiago

ZIP/Postal Code

7500347

Country

Chile

Facility Name

Investigational Site Number 152101

City

Santiago

ZIP/Postal Code

7500710

Country

Chile

Facility Name

Investigational Site Number 152105

City

Santiago

ZIP/Postal Code

7591047

Country

Chile

Facility Name

Investigational Site Number 152102

City

Santiago

ZIP/Postal Code

7980378

Country

Chile

Facility Name

Investigational Site Number 152106

City

Santiago

ZIP/Postal Code

8053095

Country

Chile

Facility Name

Investigational Site Number 152108

City

Santiago

ZIP/Postal Code

8053095

Country

Chile

Facility Name

Investigational Site Number 152109

City

Santiago

Country

Chile

Facility Name

Investigational Site Number 203107

City

Beroun

ZIP/Postal Code

26601

Country

Czech Republic

Facility Name

Investigational Site Number 203103

City

Jilove U Prahy

ZIP/Postal Code

254 01

Country

Czech Republic

Facility Name

Investigational Site Number 203101

City

Ostrava 2

ZIP/Postal Code

702 00

Country

Czech Republic

Facility Name

Investigational Site Number 203110

City

Police Nad Metuji

ZIP/Postal Code

549 54

Country

Czech Republic

Facility Name

Investigational Site Number 203105

City

Praha 4

ZIP/Postal Code

14021

Country

Czech Republic

Facility Name

Investigational Site Number 203102

City

Praha 4

ZIP/Postal Code

148 00

Country

Czech Republic

Facility Name

Investigational Site Number 203108

City

Praha 4

ZIP/Postal Code

14900

Country

Czech Republic

Facility Name

Investigational Site Number 203104

City

Trutnov

ZIP/Postal Code

54101

Country

Czech Republic

Facility Name

Investigational Site Number 233102

City

Pärnu

ZIP/Postal Code

80018

Country

Estonia

Facility Name

Investigational Site Number 233103

City

Tallinn

ZIP/Postal Code

13415

Country

Estonia

Facility Name

Investigational Site Number 233104

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Investigational Site Number 233101

City

Viljandimaa

ZIP/Postal Code

71024

Country

Estonia

Facility Name

Investigational Site Number 250108

City

Bois Guillaume

ZIP/Postal Code

76230

Country

France

Facility Name

Investigational Site Number 250105

City

Corbeil Essonnes

ZIP/Postal Code

91100

Country

France

Facility Name

Investigational Site Number 250104

City

La Rochelle Cedex

ZIP/Postal Code

17019

Country

France

Facility Name

Investigational Site Number 250106

City

Lyon

ZIP/Postal Code

69495

Country

France

Facility Name

Investigational Site Number 250107

City

Lyon

ZIP/Postal Code

69495

Country

France

Facility Name

Investigational Site Number 250109

City

Mantes La Jolie

ZIP/Postal Code

78200

Country

France

Facility Name

Investigational Site Number 250102

City

Paris Cedex 15

ZIP/Postal Code

75908

Country

France

Facility Name

Investigational Site Number 250101

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Investigational Site Number 250103

City

Venissieux

ZIP/Postal Code

69200

Country

France

Facility Name

Investigational Site Number 276112

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Investigational Site Number 276108

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Investigational Site Number 276102

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Investigational Site Number 276120

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

Investigational Site Number 276106

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Investigational Site Number 276117

City

Frankfurt A.M.

ZIP/Postal Code

60596

Country

Germany

Facility Name

Investigational Site Number 276116

City

Görlitz

ZIP/Postal Code

02826

Country

Germany

Facility Name

Investigational Site Number 276113

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

Investigational Site Number 276118

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Investigational Site Number 276119

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Investigational Site Number 276103

City

Neumünster

ZIP/Postal Code

24534

Country

Germany

Facility Name

Investigational Site Number 276115

City

Speyer

ZIP/Postal Code

67346

Country

Germany

Facility Name

Investigational Site Number 276109

City

St. Ingbert-Oberwürzbach

ZIP/Postal Code

66386

Country

Germany

Facility Name

Investigational Site Number 348107

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Investigational Site Number 348108

City

Budapest

ZIP/Postal Code

1138

Country

Hungary

Facility Name

Investigational Site Number 348102

City

Budapest

ZIP/Postal Code

1139

Country

Hungary

Facility Name

Investigational Site Number 348101

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Investigational Site Number 348103

City

Pápa

ZIP/Postal Code

8500

Country

Hungary

Facility Name

Investigational Site Number 348104

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Investigational Site Number 348106

City

Sátoraljaújhely

ZIP/Postal Code

3980

Country

Hungary

Facility Name

Investigational Site Number 348105

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Investigational Site Number 380103

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Investigational Site Number 380102

City

Catania

ZIP/Postal Code

95122

Country

Italy

Facility Name

Investigational Site Number 380101

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 380105

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Investigational Site Number 380104

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Investigational Site Number 428103

City

Jelgava

ZIP/Postal Code

LV-3001

Country

Latvia

Facility Name

Investigational Site Number 428104

City

Ogre

ZIP/Postal Code

LV-5001

Country

Latvia

Facility Name

Investigational Site Number 428102

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Investigational Site Number 428105

City

Riga

ZIP/Postal Code

LV-1006

Country

Latvia

Facility Name

Investigational Site Number 428101

City

Sigulda

ZIP/Postal Code

LV-2150

Country

Latvia

Facility Name

Investigational Site Number 440104

City

Jonava

ZIP/Postal Code

LT-55201

Country

Lithuania

Facility Name

Investigational Site Number 440103

City

Kaunas

ZIP/Postal Code

LT-48259

Country

Lithuania

Facility Name

Investigational Site Number 440102

City

Kaunas

ZIP/Postal Code

LT-49456

Country

Lithuania

Facility Name

Investigational Site Number 440101

City

Kaunas

ZIP/Postal Code

LT-51270

Country

Lithuania

Facility Name

Investigational Site Number 440105

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Investigational Site Number 484108

City

Chihuahua

ZIP/Postal Code

31200

Country

Mexico

Facility Name

Investigational Site Number 484101

City

Cuernavaca

ZIP/Postal Code

62250

Country

Mexico

Facility Name

Investigational Site Number 484111

City

Durango

ZIP/Postal Code

34080

Country

Mexico

Facility Name

Investigational Site Number 484104

City

Guadalajara

ZIP/Postal Code

44150

Country

Mexico

Facility Name

Investigational Site Number 484109

City

Guadalajara

ZIP/Postal Code

44210

Country

Mexico

Facility Name

Investigational Site Number 484107

City

Guadalajara

ZIP/Postal Code

44600

Country

Mexico

Facility Name

Investigational Site Number 484105

City

Guadalajara

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Investigational Site Number 484110

City

Guadalajara

ZIP/Postal Code

44656

Country

Mexico

Facility Name

Investigational Site Number 484103

City

Mexico Df

ZIP/Postal Code

11850

Country

Mexico

Facility Name

Investigational Site Number 484106

City

Monterrey

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Investigational Site Number 484102

City

México

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Investigational Site Number 616101

City

Bialystok

ZIP/Postal Code

15-435

Country

Poland

Facility Name

Investigational Site Number 616103

City

Bydgoszcz

ZIP/Postal Code

85-822

Country

Poland

Facility Name

Investigational Site Number 616102

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Investigational Site Number 616106

City

Krakow

ZIP/Postal Code

31-455

Country

Poland

Facility Name

Investigational Site Number 616104

City

Krakow

ZIP/Postal Code

31-548

Country

Poland

Facility Name

Investigational Site Number 616105

City

Pulawy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

Investigational Site Number 616107

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Investigational Site Number 642105

City

Bacau

ZIP/Postal Code

600114

Country

Romania

Facility Name

Investigational Site Number 642108

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Investigational Site Number 642106

City

Deva

ZIP/Postal Code

330084

Country

Romania

Facility Name

Investigational Site Number 642113

City

Galati

ZIP/Postal Code

800098

Country

Romania

Facility Name

Investigational Site Number 642107

City

Hunedoara

ZIP/Postal Code

331057

Country

Romania

Facility Name

Investigational Site Number 642117

City

Iasi

ZIP/Postal Code

700547

Country

Romania

Facility Name

Investigational Site Number 642103

City

Oradea

ZIP/Postal Code

410169

Country

Romania

Facility Name

Investigational Site Number 642104

City

Oradea

ZIP/Postal Code

410169

Country

Romania

Facility Name

Investigational Site Number 642112

City

Pitesti

ZIP/Postal Code

110084

Country

Romania

Facility Name

Investigational Site Number 642114

City

Ploiesti

ZIP/Postal Code

100342

Country

Romania

Facility Name

Investigational Site Number 642102

City

Resita

ZIP/Postal Code

320076

Country

Romania

Facility Name

Investigational Site Number 642111

City

Sibiu

ZIP/Postal Code

550371

Country

Romania

Facility Name

Investigational Site Number 642109

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Investigational Site Number 642110

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Investigational Site Number 642116

City

Timisoara

ZIP/Postal Code

300133

Country

Romania

Facility Name

Investigational Site Number 642101

City

Timisoara

ZIP/Postal Code

300456

Country

Romania

Facility Name

Investigational Site Number 642115

City

Timisoara

ZIP/Postal Code

300723

Country

Romania

Facility Name

Investigational Site Number 643111

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Investigational Site Number 643107

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Investigational Site Number 643105

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

Investigational Site Number 643110

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

Investigational Site Number 643102

City

Saratov

ZIP/Postal Code

410030

Country

Russian Federation

Facility Name

Investigational Site Number 643101

City

St-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Investigational Site Number 643104

City

St-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Investigational Site Number 643109

City

St-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Investigational Site Number 643108

City

St-Petersburg

ZIP/Postal Code

195112

Country

Russian Federation

Facility Name

Investigational Site Number 643103

City

St-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Investigational Site Number 643106

City

St. Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Investigational Site Number 724102

City

El Ferrol

ZIP/Postal Code

15403

Country

Spain

Facility Name

Investigational Site Number 724105

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 724103

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Investigational Site Number 724104

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Investigational Site Number 804104

City

Chernivtsi

ZIP/Postal Code

58022

Country

Ukraine

Facility Name

Investigational Site Number 804107

City

Donetsk

ZIP/Postal Code

83003

Country

Ukraine

Facility Name

Investigational Site Number 804103

City

Donetsk

ZIP/Postal Code

83059

Country

Ukraine

Facility Name

Investigational Site Number 804108

City

Mykolaiv

ZIP/Postal Code

54003

Country

Ukraine

Facility Name

Investigational Site Number 804110

City

Odessa

ZIP/Postal Code

65059

Country

Ukraine

Facility Name

Investigational Site Number 804105

City

Vinnytsya

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Investigational Site Number 804102

City

Vinnytsya

ZIP/Postal Code

21010

Country

Ukraine

Facility Name

Investigational Site Number 804111

City

Zaporizhia

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Investigational Site Number 826006

City

Ashton-Under-Lyne

ZIP/Postal Code

OL6 9RW

Country

United Kingdom

Facility Name

Investigational Site Number 826002

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Investigational Site Number 826007

City

Carmarthen

ZIP/Postal Code

SA31 2AF

Country

United Kingdom

Facility Name

Investigational Site Number 826005

City

Chester

ZIP/Postal Code

CH2 1UL

Country

United Kingdom

Facility Name

Investigational Site Number 826008

City

Coventry

ZIP/Postal Code

CV1 4FH

Country

United Kingdom

Facility Name

Investigational Site Number 826009

City

Dundee

ZIP/Postal Code

DD1 9SI

Country

United Kingdom

Facility Name

Investigational Site Number 826001

City

Durham

ZIP/Postal Code

DH1 5TW

Country

United Kingdom

Facility Name

Investigational Site Number 826011

City

Haddington

ZIP/Postal Code

EH41 3PF

Country

United Kingdom

Facility Name

Investigational Site Number 826012

City

Leicester

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Facility Name

Investigational Site Number 826010

City

Plymouth

ZIP/Postal Code

PL6 8BX

Country

United Kingdom

Facility Name

Investigational Site Number 826004

City

Sheffield

ZIP/Postal Code

S5 7AU

Country

United Kingdom

Facility Name

Investigational Site Number 826003

City

St Helens

ZIP/Postal Code

WA93DA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27222510

Citation

Rosenstock J, Guerci B, Hanefeld M, Gentile S, Aronson R, Tinahones FJ, Roy-Duval C, Souhami E, Wardecki M, Ye J, Perfetti R, Heller S; GetGoal Duo-2 Trial Investigators. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care. 2016 Aug;39(8):1318-28. doi: 10.2337/dc16-0014. Epub 2016 May 23.

Results Reference

result

PubMed Identifier

31848983

Citation

Tabak AG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.

Results Reference

derived

PubMed Identifier

29974618

Citation

Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

We'll reach out to this number within 24 hrs

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients (GetGoal-Duo-2)

Type 2 Diabetes

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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