AzTrials
AzTrials

Diabetes Mellitus Type 2Phase 3GETGOAL-PNCT00763815

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

A Phase 3 study testing Lixisenatide (AVE0010), Pen auto-injector and Pioglitazone in people with Diabetes Mellitus Type 2, run by Sanofi at 150 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Lixisenatide (AVE0010), Pen auto-injector and Pioglitazone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
484 participants
Where
150 sitesin 13 countries
Study dates
Sep 2008to Jun 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

150 sites in 13 countries.

150 sites in 13 countries

United States85 sites

  • Sanofi-Aventis Investigational Site Number 840795

    Artesia, California, 90701

  • Sanofi-Aventis Investigational Site Number 840777

    Athens, Ohio, 45701

  • Sanofi-Aventis Investigational Site Number 840857

    Augusta, Georgia, 30909

  • Sanofi-Aventis Investigational Site Number 840738

    Avon, Indiana, 46123

  • Sanofi-Aventis Investigational Site Number 840862

    Baton Rouge, Louisiana, 70808

  • Sanofi-Aventis Investigational Site Number 840751

    Beaver, Pennsylvania, 15009

  • Sanofi-Aventis Investigational Site Number 840723

    Birmingham, Alabama, 35205

  • Sanofi-Aventis Investigational Site Number 840744

    Birmingham, Alabama, 35205

  • Sanofi-Aventis Investigational Site Number 840867

    Birmingham, Alabama, 35235

  • Sanofi-Aventis Investigational Site Number 840720

    Birmingham, Alabama, 35242

  • Sanofi-Aventis Investigational Site Number 840780

    Bismarck, North Dakota, 58501

  • Sanofi-Aventis Investigational Site Number 840774

    Bloomington, Minnesota, 55435

  • Sanofi-Aventis Investigational Site Number 840711

    Bristol, Tennessee, 37620

  • Sanofi-Aventis Investigational Site Number 840747

    Burlington, North Carolina, 27215

  • Sanofi-Aventis Investigational Site Number 840775

    Chandler, Arizona, 85224

  • Sanofi-Aventis Investigational Site Number 840791

    Chicago, Illinois, 60611

  • Sanofi-Aventis Investigational Site Number 840782

    Chino, California, 91710

  • Sanofi-Aventis Investigational Site Number 840741

    Cleveland, Ohio, 44122

  • Sanofi-Aventis Investigational Site Number 840796

    Clinton, Utah, 84015

  • Sanofi-Aventis Investigational Site Number 840853

    Colleyville, Texas, 76034

  • Sanofi-Aventis Investigational Site Number 840872

    Colorado Springs, Colorado, 80907

  • Sanofi-Aventis Investigational Site Number 840868

    Colorado Springs, Colorado, 80909

  • Sanofi-Aventis Investigational Site Number 840792

    Columbia, South Carolina, 29201

  • Sanofi-Aventis Investigational Site Number 840728

    Dayton, Ohio, 45458

  • Sanofi-Aventis Investigational Site Number 840704

    Eagan, Minnesota, 55122

  • Sanofi-Aventis Investigational Site Number 840877

    Fargo, North Dakota, 58103

  • Sanofi-Aventis Investigational Site Number 840760

    Greensboro, North Carolina, 27401

  • Sanofi-Aventis Investigational Site Number 840729

    Harrisburg, Arkansas, 72432

  • Sanofi-Aventis Investigational Site Number 840712

    High Point, North Carolina, 27262

  • Sanofi-Aventis Investigational Site Number 840730

    Houston, Texas, 77030

  • Sanofi-Aventis Investigational Site Number 840785

    Huntington Beach, California, 92648

  • Sanofi-Aventis Investigational Site Number 840764

    Hyattsville, Maryland, 20783

  • Sanofi-Aventis Investigational Site Number 840724

    Idaho Falls, Idaho, 83404

  • Sanofi-Aventis Investigational Site Number 840794

    Indianapolis, Indiana, 46260

  • Sanofi-Aventis Investigational Site Number 840727

    Jacksonville, Florida, 32216

  • Sanofi-Aventis Investigational Site Number 840708

    Kalamazoo, Michigan, 49001

  • Sanofi-Aventis Investigational Site Number 840767

    Kansas City, Kansas, 66160-7321

  • Sanofi-Aventis Investigational Site Number 840858

    La Jolla, California, 92037

  • Sanofi-Aventis Investigational Site Number 840779

    Lansing, Kansas, 66043

  • Sanofi-Aventis Investigational Site Number 840875

    Las Vegas, Nevada, 89119

  • Sanofi-Aventis Investigational Site Number 840789

    Lexington, Kentucky, 40503

  • Sanofi-Aventis Investigational Site Number 840850

    Lexington, Kentucky, 40504

  • Sanofi-Aventis Investigational Site Number 840784

    Los Banos, California, 93635

  • Sanofi-Aventis Investigational Site Number 840701

    Medford, Oregon, 97504

  • Sanofi-Aventis Investigational Site Number 840709

    Mentor, Ohio, 44060

  • Sanofi-Aventis Investigational Site Number 840722

    Mesa, Arizona, 85213

  • Sanofi-Aventis Investigational Site Number 840773

    Mission Hills, California, 91345

  • Sanofi-Aventis Investigational Site Number 840707

    Mission Viejo, California, 92691

  • Sanofi-Aventis Investigational Site Number 840855

    Mobile, Alabama, 36608

  • Sanofi-Aventis Investigational Site Number 840863

    Mobile, Alabama, 36608

  • Sanofi-Aventis Investigational Site Number 840776

    Mountain Home, Arkansas, 72653

  • Sanofi-Aventis Investigational Site Number 840745

    New Port Richey, Florida, 34652

  • Sanofi-Aventis Investigational Site Number 840865

    New York, New York, 10010

  • Sanofi-Aventis Investigational Site Number 840766

    New York, New York, 10021

  • Sanofi-Aventis Investigational Site Number 840753

    Norfolk, Virginia, 23510

  • Sanofi-Aventis Investigational Site Number 840770

    Norfolk, Virginia, 23510

  • Sanofi-Aventis Investigational Site Number 840716

    Norman, Oklahoma, 73069

  • Sanofi-Aventis Investigational Site Number 840733

    Northridge, California, 91325

  • Sanofi-Aventis Investigational Site Number 840761

    Oviedo, Florida, 32765

  • Sanofi-Aventis Investigational Site Number 840866

    Pahrump, Nevada, 89048

  • Sanofi-Aventis Investigational Site Number 840769

    Phoenix, Arizona, 85050

  • Sanofi-Aventis Investigational Site Number 840717

    Picayune, Mississippi, 39466

  • Sanofi-Aventis Investigational Site Number 840798

    Red Lion, Pennsylvania, 17356

  • Sanofi-Aventis Investigational Site Number 840752

    Richmond, Virginia, 23220

  • Sanofi-Aventis Investigational Site Number 840871

    Rockville, Maryland, 20850

  • Sanofi-Aventis Investigational Site Number 840864

    Roseville, California, 95661

  • Sanofi-Aventis Investigational Site Number 840851

    Russells Mills, Massachusetts, 2747

  • Sanofi-Aventis Investigational Site Number 840755

    Salt Lake City, Utah, 84102

  • Sanofi-Aventis Investigational Site Number 840756

    Salt Lake City, Utah, 84107

  • Sanofi-Aventis Investigational Site Number 840758

    Salt Lake City, Utah, 84107

  • Sanofi-Aventis Investigational Site Number 840854

    San Antonio, Texas, 78218

  • Sanofi-Aventis Investigational Site Number 840772

    San Diego, California, 92123

  • Sanofi-Aventis Investigational Site Number 840743

    San Mateo, California, 94401

  • Sanofi-Aventis Investigational Site Number 840879

    Shreveport, Louisiana, 71101

  • Sanofi-Aventis Investigational Site Number 840740

    Simpsonville, South Carolina, 29681

  • Sanofi-Aventis Investigational Site Number 840735

    Spokane, Washington, 99209

  • Sanofi-Aventis Investigational Site Number 840765

    St Louis, Missouri, 63104

  • Sanofi-Aventis Investigational Site Number 840874

    Staten Island, New York, 10301

  • Sanofi-Aventis Investigational Site Number 840721

    Stockton, California, 95204

  • Sanofi-Aventis Investigational Site Number 840726

    Taylors, South Carolina, 29687-4105

  • Sanofi-Aventis Investigational Site Number 840757

    Virginia Beach, Virginia, 23502

  • Sanofi-Aventis Investigational Site Number 840799

    Wellington, Florida, 33414

  • Sanofi-Aventis Investigational Site Number 840763

    West Hills, California, 91307

  • Sanofi-Aventis Investigational Site Number 840762

    West Seneca, New York, 14224

  • Sanofi-Aventis Investigational Site Number 840739

    Wichita, Kansas, 67203

Other trials in United States

Romania14 sites

  • Sanofi-Aventis Investigational Site Number 642711

    Alba Iulia, 510 217

  • Sanofi-Aventis Investigational Site Number 642702

    Bacau, 600164

  • Sanofi-Aventis Investigational Site Number 642709

    Baia Mare, 430031

  • Sanofi-Aventis Investigational Site Number 642701

    Brasov, 500326

  • Sanofi-Aventis Investigational Site Number 642712

    Bucharest, 010507

  • Sanofi-Aventis Investigational Site Number 642714

    Bucharest, 20475

  • Sanofi-Aventis Investigational Site Number 642705

    Constanța, 900591

  • Sanofi-Aventis Investigational Site Number 642707

    Galati, 800575

  • Sanofi-Aventis Investigational Site Number 642703

    Ploieşti, 100097

  • Sanofi-Aventis Investigational Site Number 642713

    Reşiţa, 320076

  • Sanofi-Aventis Investigational Site Number 642708

    Satu Mare, 440055

  • Sanofi-Aventis Investigational Site Number 642706

    Târgu Mureş, 540061

  • Sanofi-Aventis Investigational Site Number 642715

    Timișoara, 300456

  • Sanofi-Aventis Investigational Site Number 642710

    Timișoara, 300593

Other trials in Romania

Canada10 sites

  • Sanofi-Aventis Investigational Site Number 124716

    Greater Sudbury, P3E 2P2

  • Sanofi-Aventis Investigational Site Number 124710

    London, N6A 5R8

  • Sanofi-Aventis Investigational Site Number 124712

    Mirabel, J7J 2K8

  • Sanofi-Aventis Investigational Site Number 124705

    Saint Romuald, G6W 5M6

  • Sanofi-Aventis Investigational Site Number 124703

    Saskatoon, S7K 3H3

  • Sanofi-Aventis Investigational Site Number 124713

    Scarborough, M1E 5E9

  • Sanofi-Aventis Investigational Site Number 124711

    Sherbrooke, J1H 5N4

  • Sanofi-Aventis Investigational Site Number 124704

    Smiths Falls, K7A 4W8

  • Sanofi-Aventis Investigational Site Number 124701

    Thornhill, L4J 8L7

  • Sanofi-Aventis Investigational Site Number 124708

    Vancouver, V5Z 1C6

Other trials in Canada

Germany7 sites

  • Sanofi-Aventis Investigational Site Number 276708

    Aßlar, 35614

  • Sanofi-Aventis Investigational Site Number 276704

    Berlin, 10115

  • Sanofi-Aventis Investigational Site Number 276703

    Künzing, 94550

  • Sanofi-Aventis Investigational Site Number 276706

    Leipzig, 04103

  • Sanofi-Aventis Investigational Site Number 276707

    Pirna, 01796

  • Sanofi-Aventis Investigational Site Number 276702

    Sulzbach-Rosenberg, 92237

  • Sanofi-Aventis Investigational Site Number 276701

    Würzburg, 97072

Other trials in Germany

Austria6 sites

  • Sanofi-Aventis Investigational Site Number 040706

    Graz, 8036

  • Sanofi-Aventis Investigational Site Number 040702

    Vienna, 1030

  • Sanofi-Aventis Investigational Site Number 040704

    Vienna, 1060

  • Sanofi-Aventis Investigational Site Number 040701

    Vienna, 1100

  • Sanofi-Aventis Investigational Site Number 040705

    Vienna, 1100

  • Sanofi-Aventis Investigational Site Number 040707

    Wels, 4600

Other trials in Austria

France5 sites

  • Sanofi-Aventis Investigational Site Number 250704

    Armentières, 59427

  • Sanofi-Aventis Investigational Site Number 250707

    La Rochelle, 17019

  • Sanofi-Aventis Investigational Site Number 250705

    Labarthe-sur-Lèze, 31860

  • Sanofi-Aventis Investigational Site Number 250702

    Le Creusot, 71200

  • Sanofi-Aventis Investigational Site Number 250701

    Strasbourg, 67091

Other trials in France

Greece4 sites

  • Sanofi-Aventis Investigational Site Number 300705

    Athens, 10552

  • Sanofi-Aventis Investigational Site Number 300703

    Athens

  • Sanofi-Aventis Investigational Site Number 300704

    Athens

  • Sanofi-Aventis Investigational Site Number 300701

    Thessaloniki, 56429

Other trials in Greece

Guatemala4 sites

  • Sanofi-Aventis Investigational Site Number 320702

    Guatemala City, 01010

  • Sanofi-Aventis Investigational Site Number 320701

    Guatemala City, 01014

  • Sanofi-Aventis Investigational Site Number 320703

    Guatemala City

  • Sanofi-Aventis Investigational Site Number 320704

    Guatemala City

Other trials in Guatemala

India4 sites

  • Sanofi-Aventis Investigational Site Number 356701

    Bangalore, 560010

  • Sanofi-Aventis Investigational Site Number 356703

    Bangalore, 560052

  • Sanofi-Aventis Investigational Site Number 356702

    Hyderabad, 500001

  • Sanofi-Aventis Investigational Site Number 356704

    Nagpur, 440012

Other trials in India

Peru4 sites

  • Sanofi-Aventis Investigational Site Number 604703

    Lima, Lima 27

  • Sanofi-Aventis Investigational Site Number 604701

    Lima, LIMA 31

  • Sanofi-Aventis Investigational Site Number 604702

    Lima

  • Sanofi-Aventis Investigational Site Number 604705

    Lima

Other trials in Peru

Mexico3 sites

  • Sanofi-Aventis Investigational Site Number 484703

    Mérida, 97000

  • Sanofi-Aventis Investigational Site Number 484701

    Tlalnepantla, 53160

  • Sanofi-Aventis Investigational Site Number 484704

    Zapopan, 44030

Other trials in Mexico

Puerto Rico2 sites

  • Sanofi-Aventis Investigational Site Number 630714

    Carolina, 00983

  • Sanofi-Aventis Investigational Site Number 630715

    Carolina, 00983

Other trials in Puerto Rico

Turkey (Türkiye)2 sites

  • Sanofi-Aventis Investigational Site Number 792702

    Erzurum

  • Sanofi-Aventis Investigational Site Number 792705

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Lixisenatide (AVE0010), Placebo, Pen auto-injector, Pioglitazone, Metformin
Keywords
hyperglycemia GLP-1 pioglitazone
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lixisenatide (AVE0010)Drug

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

  • PlaceboDrug

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

  • Pen auto-injectorDevice

    Also called OptiClik®

  • PioglitazoneDrug

    Dose to be kept stable.

  • MetforminDrug

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

Study groups in NCT00763815
Study groupRoleWhat they receive
LixisenatideExperimental2-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.
Receives: Drug: Lixisenatide (AVE0010); Device: Pen auto-injector; Drug: Pioglitazone; Drug: Metformin
PlaceboPlacebo comparator2-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.
Receives: Drug: Placebo; Device: Pen auto-injector; Drug: Pioglitazone; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 24

Secondary outcomes (7)

  1. 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.

    Measured: Baseline, Week 24

  2. 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.

    Measured: Baseline, Week 24

  3. Change From Baseline in Fasting Plasma Insulin (FPI) 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.

    Measured: Baseline, Week 24

  4. 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.

    Measured: Week 24

  5. Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% 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.

    Measured: Week 24

  6. 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.

    Measured: Baseline, Week 24

  7. 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.

    Measured: Baseline up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
484 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00763815
Sponsor's protocol ID
EFC6017
Other IDs
EudraCT: 2007-005884-92
Acronym
GETGOAL-P
Status last verified
Oct 2016
First submitted
30 Sep 2008
Last updated
28 Nov 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23627775

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lixisenatide (AVE0010), Pen auto-injector and Pioglitazone in people with Diabetes Mellitus Type 2, run by Sanofi at 150 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Romania, Canada, Germany, Austria and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00763815, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.

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