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GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone (GETGOAL-P)

Primary Purpose

Diabetes Mellitus Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Lixisenatide (AVE0010)

Placebo

Pen auto-injector

Pioglitazone

Metformin

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring hyperglycemia GLP-1 pioglitazone

Eligibility Criteria

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

Inclusion Criteria:

Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone

Exclusion Criteria:

HbA1c less than (<) 7 percent (%) or greater than (>) 10% at screening
At the time of screening age <legal age of majority
Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
Type 1 diabetes mellitus
Pioglitazone not at a stable dose of at least 30 milligram per day (mg/day) for at least 3 months prior to screening
If treatment with metformin, no stable dose of at least 1.5 gram per day (g/day) for at least 3 months prior to screening visit
FPG at screening >250 milligram per deciliter (mg/dL) (>13.9 millimole per liter [mmol/L])
Body mass index less than or equal to (<=) 20 kilogram per square meter (kg/m^2)
Weight change of more than 5 kg during the 3 months preceding the screening visit
History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease
History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
Hemoglobinopathy or hemolytic anemia, or receipt of blood or plasma products within3 months prior to the time of screening
History of myocardial infarction or stroke within the last 6 months prior to screening
Known history of drug or alcohol abuse within 6 months prior to the time of screening
Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively
Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): >2 times upper limit of normal (ULN) laboratory range; amylase and/or lipase: >3 times ULN; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); Hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb); positive serum pregnancy test in females of childbearing potential
Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG), or vital signs at the time of screening that, in the judgment of the investigator or any sub-investigator, precludes safe completion of the study or constrains efficacy assessment
Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements [such as scheduled visits, being able to do self-injections]; likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)
Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin or pioglitazone (for example, sulfonylurea, alpha-glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, dipeptidyl peptidase-4 [DPP-4] inhibitors, insulin) within 3 months prior to the time of screening
Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening
Use of any investigational drug within 3 months prior to study
Any previous treatment with lixisenatide or participation in a previous study with lixisenatide
Renal impairment defined with creatinine >1.4 mg/dL in women and creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment)
Patients with cardiac failure or history of cardiac failure (New York Heart Association class I to IV)
End-stage renal disease defined by a serum creatinine clearance of <15 milliliter per minute (mL/min) (calculated by the Cockcroft and Gault formula) and/or patients on dialysis, if no treatment with metformin
Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example,exenatide, liraglutide) or to metacresol
Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lixisenatide

Placebo

Arm Description

2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.

2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Change From Baseline in Body Weight at Week 24

Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24

The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24

Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24

Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period

Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Full Information

NCT ID

NCT00763815

First Posted

September 30, 2008

Last Updated

October 14, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00763815

Brief Title

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

Acronym

GETGOAL-P

Official Title

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed Description

Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the schedule date of Week 76 visit (Visit 25) for the last randomized patients.

6. Conditions and Keywords

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

Diabetes Mellitus Type 2

Keywords

hyperglycemia GLP-1 pioglitazone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

484 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lixisenatide

Arm Type

Experimental

Arm Description

2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.

Intervention Type

Drug

Intervention Name(s)

Lixisenatide (AVE0010)

Intervention Description

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Intervention Type

Device

Intervention Name(s)

Pen auto-injector

Other Intervention Name(s)

OptiClik®

Intervention Type

Drug

Intervention Name(s)

Pioglitazone

Intervention Description

Dose to be kept stable.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Primary Outcome Measure Information:

Title

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Description

Time Frame

Baseline, Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Body Weight at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24

Description

Time Frame

Week 24

Title

Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24

Description

Time Frame

Week 24

Title

Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period

Description

Time Frame

Baseline up to Week 24

Other Pre-specified Outcome Measures:

Title

Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24

Description

The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Time Frame

Baseline, Week 24

Title

Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia

Description

Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient 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.

Time Frame

First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone Exclusion Criteria: HbA1c less than (<) 7 percent (%) or greater than (>) 10% at screening At the time of screening age <legal age of majority Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control Type 1 diabetes mellitus Pioglitazone not at a stable dose of at least 30 milligram per day (mg/day) for at least 3 months prior to screening If treatment with metformin, no stable dose of at least 1.5 gram per day (g/day) for at least 3 months prior to screening visit FPG at screening >250 milligram per deciliter (mg/dL) (>13.9 millimole per liter [mmol/L]) Body mass index less than or equal to (<=) 20 kilogram per square meter (kg/m^2) Weight change of more than 5 kg during the 3 months preceding the screening visit History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening Hemoglobinopathy or hemolytic anemia, or receipt of blood or plasma products within3 months prior to the time of screening History of myocardial infarction or stroke within the last 6 months prior to screening Known history of drug or alcohol abuse within 6 months prior to the time of screening Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): >2 times upper limit of normal (ULN) laboratory range; amylase and/or lipase: >3 times ULN; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); Hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb); positive serum pregnancy test in females of childbearing potential Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG), or vital signs at the time of screening that, in the judgment of the investigator or any sub-investigator, precludes safe completion of the study or constrains efficacy assessment Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements [such as scheduled visits, being able to do self-injections]; likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol) Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin or pioglitazone (for example, sulfonylurea, alpha-glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, dipeptidyl peptidase-4 [DPP-4] inhibitors, insulin) within 3 months prior to the time of screening Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening Use of any investigational drug within 3 months prior to study Any previous treatment with lixisenatide or participation in a previous study with lixisenatide Renal impairment defined with creatinine >1.4 mg/dL in women and creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment) Patients with cardiac failure or history of cardiac failure (New York Heart Association class I to IV) End-stage renal disease defined by a serum creatinine clearance of <15 milliliter per minute (mL/min) (calculated by the Cockcroft and Gault formula) and/or patients on dialysis, if no treatment with metformin Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example,exenatide, liraglutide) or to metacresol Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator

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

Sanofi-Aventis Investigational Site Number 840723

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840744

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840867

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35235

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840720

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35242

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840855

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840863

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840775

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840722

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85213

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840769

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840729

City

Harrisburg

State/Province

Arkansas

ZIP/Postal Code

72432

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840776

City

Mountain Home

State/Province

Arkansas

ZIP/Postal Code

72653

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840795

City

Artesia

State/Province

California

ZIP/Postal Code

90701

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840782

City

Chino

State/Province

California

ZIP/Postal Code

91710

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840785

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840858

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840784

City

Los Banos

State/Province

California

ZIP/Postal Code

93635

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840773

City

Mission Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840707

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840733

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840864

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840772

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840743

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840721

City

Stockton

State/Province

California

ZIP/Postal Code

95204

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840763

City

West Hills

State/Province

California

ZIP/Postal Code

91307

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840872

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840868

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840727

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840745

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840761

City

Oviedo

State/Province

Florida

ZIP/Postal Code

32765

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840799

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840857

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840724

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840791

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840738

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840794

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840767

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160-7321

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840779

City

Lansing

State/Province

Kansas

ZIP/Postal Code

66043

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840739

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840789

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840850

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840862

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840879

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840764

City

Hyattsville

State/Province

Maryland

ZIP/Postal Code

20783

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840871

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840851

City

Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

2747

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840708

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49001

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840774

City

Bloomington

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840704

City

Eagan

State/Province

Minnesota

ZIP/Postal Code

55122

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840717

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840765

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840875

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840866

City

Pahrump

State/Province

Nevada

ZIP/Postal Code

89048

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840766

City

New York City

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840865

City

New York

State/Province

New York

ZIP/Postal Code

10010

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840874

City

Staten Island

State/Province

New York

ZIP/Postal Code

10301

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840762

City

West Seneca

State/Province

New York

ZIP/Postal Code

14224

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840747

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840760

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840712

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840780

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840877

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840777

City

Athens

State/Province

Ohio

ZIP/Postal Code

45701

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840741

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840728

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45458

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840709

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840716

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840701

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840751

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840798

City

Red Lion

State/Province

Pennsylvania

ZIP/Postal Code

17356

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840792

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840740

City

Simpsonville

State/Province

South Carolina

ZIP/Postal Code

29681

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840726

City

Taylors

State/Province

South Carolina

ZIP/Postal Code

29687-4105

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840711

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840853

City

Colleyville

State/Province

Texas

ZIP/Postal Code

76034

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840730

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840854

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840796

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840755

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840756

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840758

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840753

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840770

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840752

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23220

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840757

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840735

City

Spokane

State/Province

Washington

ZIP/Postal Code

99209

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 040706

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 040704

City

Vienna

ZIP/Postal Code

1060

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 040707

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 040702

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 040701

City

Wien

ZIP/Postal Code

1100

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 040705

City

Wien

ZIP/Postal Code

1100

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 124710

City

London

ZIP/Postal Code

N6A 5R8

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124712

City

Mirabel

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124703

City

Saskatoon

ZIP/Postal Code

S7K 3H3

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124713

City

Scarborough

ZIP/Postal Code

M1E 5E9

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124711

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124704

City

Smiths Falls

ZIP/Postal Code

K7A 4W8

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124705

City

St-Romuald

ZIP/Postal Code

G6W 5M6

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124716

City

Sudbury

ZIP/Postal Code

P3E 2P2

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124701

City

Thornhill

ZIP/Postal Code

L4J 8L7

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124708

City

Vancouver

ZIP/Postal Code

V5Z 1C6

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 250704

City

Armentieres

ZIP/Postal Code

59427

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250707

City

La Rochelle Cedex

ZIP/Postal Code

17019

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250705

City

Labarthe Sur Leze

ZIP/Postal Code

31860

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250702

City

Le Creusot

ZIP/Postal Code

71200

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250701

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 276708

City

Asslar

ZIP/Postal Code

35614

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276704

City

Berlin

ZIP/Postal Code

10115

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276703

City

Künzing

ZIP/Postal Code

94550

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276706

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276707

City

Pirna

ZIP/Postal Code

01796

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276702

City

Sulzbach-Rosenberg

ZIP/Postal Code

92237

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276701

City

Würzburg

ZIP/Postal Code

97072

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 300705

City

Athens

ZIP/Postal Code

10552

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 300703

City

Athens

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 300704

City

Athens

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 300701

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 320702

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Sanofi-Aventis Investigational Site Number 320701

City

Guatemala

ZIP/Postal Code

01014

Country

Guatemala

Facility Name

Sanofi-Aventis Investigational Site Number 320703

City

Guatemala

Country

Guatemala

Facility Name

Sanofi-Aventis Investigational Site Number 320704

City

Guatemala

Country

Guatemala

Facility Name

Sanofi-Aventis Investigational Site Number 356701

City

Bangalore

ZIP/Postal Code

560010

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 356703

City

Bangalore

ZIP/Postal Code

560052

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 356702

City

Hyderabad

ZIP/Postal Code

500001

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 356704

City

Nagpur

ZIP/Postal Code

440012

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 484703

City

Merida

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Sanofi-Aventis Investigational Site Number 484701

City

Tlalnepantla

ZIP/Postal Code

53160

Country

Mexico

Facility Name

Sanofi-Aventis Investigational Site Number 484704

City

Zapopan

ZIP/Postal Code

44030

Country

Mexico

Facility Name

Sanofi-Aventis Investigational Site Number 604703

City

Lima

ZIP/Postal Code

Lima 27

Country

Peru

Facility Name

Sanofi-Aventis Investigational Site Number 604701

City

Lima

ZIP/Postal Code

LIMA 31

Country

Peru

Facility Name

Sanofi-Aventis Investigational Site Number 604702

City

Lima

Country

Peru

Facility Name

Sanofi-Aventis Investigational Site Number 604705

City

Lima

Country

Peru

Facility Name

Sanofi-Aventis Investigational Site Number 630714

City

Carolina

ZIP/Postal Code

00983

Country

Puerto Rico

Facility Name

Sanofi-Aventis Investigational Site Number 630715

City

Carolina

ZIP/Postal Code

00983

Country

Puerto Rico

Facility Name

Sanofi-Aventis Investigational Site Number 642711

City

Alba Iulia

ZIP/Postal Code

510 217

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642702

City

Bacau

ZIP/Postal Code

600164

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642709

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642701

City

Brasov

ZIP/Postal Code

500326

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642712

City

Bucuresti

ZIP/Postal Code

010507

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642714

City

Bucuresti

ZIP/Postal Code

20475

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642705

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642707

City

Galati

ZIP/Postal Code

800575

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642703

City

Ploiesti

ZIP/Postal Code

100097

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642713

City

Resita

ZIP/Postal Code

320076

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642708

City

Satu Mare

ZIP/Postal Code

440055

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642706

City

Targu Mures

ZIP/Postal Code

540061

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642715

City

Timisoara

ZIP/Postal Code

300456

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642710

City

Timisoara

ZIP/Postal Code

300593

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 792702

City

Erzurum

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792705

City

Istanbul

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

23627775

Citation

Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013 Nov;15(11):1000-7. doi: 10.1111/dom.12121. Epub 2013 May 26.

Results Reference

result

Learn more about this trial

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

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GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone (GETGOAL-P)

Diabetes Mellitus Type 2

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