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AzTrials

Type 2 Diabetes MellitusPhase 3GetGoal-Duo1NCT00975286

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

A Phase 3 study testing Lixisenatide (AVE0010), Insulin glargine and Pen auto-injector in people with Type 2 Diabetes Mellitus, run by Sanofi at 140 sites in 26 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 the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Lixisenatide (AVE0010), Insulin glargine and Pen auto-injector
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
446 participants
Where
140 sitesin 26 countries
Study dates
Oct 2009to Aug 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 before screening visit, insufficiently controlled with insulin glargine and metformin

Who cannot join

  • HbA1c <7% or greater than (>)10% at screening
  • At the time of screening age < legal age of majority
  • Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
  • Type 1 diabetes mellitus
  • Metformin not at a stable dose of at least 1.5 gram per day for at least 3 months prior to the screening visit
  • Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea (SU) and TZDs (for example, alpha glucosidase inhibitor, other glucagon like peptide-1 [GLP-1] receptor agonists, dipeptidyl peptidase-IV [DPP-IV] inhibitors, insulin etc.) within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit
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  • History of hypoglycemia unawareness
  • Body Mass Index (BMI) less than or equal to (<=) 20 kilogram per square meter (kg/m^2)
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for example, multiple endocrine neoplasia syndromes)
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
  • Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion within 3 months prior to the time of screening
  • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
  • Known history of drug or alcohol abuse within 6 months prior to the time of screening
  • Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram 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 such as active malignant tumor or other major systemic diseases, presence of clinically significant diabetic retinopathy 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 or diastolic blood pressure >180 millimeter of mercury (mmHg) or >110 mmHg, respectively
  • Laboratory findings at the time of screening: amylase and/or lipase, alanine aminotransferase >3 times upper limit of the normal (ULN) laboratory range; 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 and/or Hepatitis C antibody, positive serum pregnancy test in females of childbearing potential; and calcitonin >=20 picogram per milliliter (pg/mL) (5.9 picomole per milliliter [pmol/L])
  • 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, patient being investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol etc.)
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
  • Use of any investigational drug within 3 months prior to screening
  • Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
  • History of hypersensitivity to insulin glargine or to any of the excipients
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
  • Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)
  • Allergic reaction to any GLP-1 receptor agonist in the past (for example, exenatide, liraglutide) or to metacresol
  • Additional exclusion criteria during or at the end of the run-in phase before randomization: informed consent withdrawal (patient who was not willing to continue or failed to return), mean fasting SMPG calculated from the self-measurements for the 7 days prior to Visit 12 (Week -1) was >140 mg/dL (7.8 mmol/L) and HbA1c measured at Visit 12 (Week -1) is <7% or >9%, amylase and/or lipase > 3 times the ULN at Visit 12 (Week -1), patients with fasting plasma glucose (FPG) above the threshold value described for rescue (that is, FPG >240 mg/dL [13.3 mmol/L]), patients with any adverse event, which, by the judgment of the Investigator precludes the inclusion in the double-blind randomized treatment phase, and lack of compliance to protocol or to insulin glargine treatment during the run-in phase

Trial locations and contacts

140 sites in 26 countries.

140 sites in 26 countries

United States23 sites

  • Sanofi-Aventis Investigational Site Number 840211

    Baton Rouge, Louisiana, 70808

  • Sanofi-Aventis Investigational Site Number 840219

    Brighton, Michigan, 48114

  • Sanofi-Aventis Investigational Site Number 840229

    Bristol, Tennessee, 37620

  • Sanofi-Aventis Investigational Site Number 840215

    Concord, California, 94520

  • Sanofi-Aventis Investigational Site Number 840210

    Dallas, Texas, 75230

  • Sanofi-Aventis Investigational Site Number 840208

    Fargo, North Dakota, 58103

  • Sanofi-Aventis Investigational Site Number 840205

    Germantown, Tennessee, 38138

  • Sanofi-Aventis Investigational Site Number 840214

    Greenbrae, California, 94904

  • Sanofi-Aventis Investigational Site Number 840206

    Hot Springs, Arkansas, 71913

  • Sanofi-Aventis Investigational Site Number 840217

    Houston, Texas, 77081

  • Sanofi-Aventis Investigational Site Number 840228

    Houston, Texas, 77081

  • Sanofi-Aventis Investigational Site Number 840230

    Hyattsville, Maryland, 20781

  • Sanofi-Aventis Investigational Site Number 840201

    Little Rock, Arkansas, 72205

  • Sanofi-Aventis Investigational Site Number 840225

    Mentor, Ohio, 44060

  • Sanofi-Aventis Investigational Site Number 840223

    Mesa, Arizona, 85206

  • Sanofi-Aventis Investigational Site Number 840212

    Mountain Home, Arkansas, 72653

  • Sanofi-Aventis Investigational Site Number 840227

    Norfolk, Virginia, 23502

  • Sanofi-Aventis Investigational Site Number 840221

    Orlando, Florida, 32835

  • Sanofi-Aventis Investigational Site Number 840202

    Philadelphia, Pennsylvania, 19146

  • Sanofi-Aventis Investigational Site Number 840213

    Plano, Texas, 75093

  • Sanofi-Aventis Investigational Site Number 840222

    Portland, Oregon, 97201-3098

  • Sanofi-Aventis Investigational Site Number 840209

    Rockville, Maryland, 20852

  • Sanofi-Aventis Investigational Site Number 840231

    Sea Girt, New Jersey, 08750

Other trials in United States

Canada11 sites

  • Sanofi-Aventis Investigational Site Number 124219

    Brampton, L6R 3J5

  • Sanofi-Aventis Investigational Site Number 124213

    Chatham, N7L 1C1

  • Sanofi-Aventis Investigational Site Number 124208

    Chilliwack, V2P 4M9

  • Sanofi-Aventis Investigational Site Number 124215

    Etobicoke, M9R 4E1

  • Sanofi-Aventis Investigational Site Number 124205

    Québec, G1V 4G5

  • Sanofi-Aventis Investigational Site Number 124202

    Red Deer, T4N 6V7

  • Sanofi-Aventis Investigational Site Number 124218

    Thornhill, L4J 8L7

  • Sanofi-Aventis Investigational Site Number 124201

    Toronto, M4R 2G4

  • Sanofi-Aventis Investigational Site Number 124207

    Toronto, M9V 4B4

  • Sanofi-Aventis Investigational Site Number 124209

    Victoria, V8V 4A1

  • Sanofi-Aventis Investigational Site Number 124217

    Winnipeg, R3E 3P4

Other trials in Canada

India10 sites

  • Sanofi-Aventis Investigational Site Number 356210

    Ahmedabad, 380015

  • Sanofi-Aventis Investigational Site Number 356206

    Bangalore, 560043

  • Sanofi-Aventis Investigational Site Number 356204

    Bangalore, 560052

  • Sanofi-Aventis Investigational Site Number 356202

    Bangalore

  • Sanofi-Aventis Investigational Site Number 356201

    Belagavi, 590001

  • Sanofi-Aventis Investigational Site Number 356205

    Chennai, 600086

  • Sanofi-Aventis Investigational Site Number 356208

    Indore, 452010

  • Sanofi-Aventis Investigational Site Number 356203

    Karnāl, 132001

  • Sanofi-Aventis Investigational Site Number 356207

    Kochi

  • Sanofi-Aventis Investigational Site Number 356209

    Nagpur, 440012

Other trials in India

Romania8 sites

  • Sanofi-Aventis Investigational Site Number 642204

    Brasov, 500326

  • Sanofi-Aventis Investigational Site Number 642208

    Bucharest, 020725

  • Sanofi-Aventis Investigational Site Number 642205

    Deva, 330084

  • Sanofi-Aventis Investigational Site Number 642203

    Iași, 700515

  • Sanofi-Aventis Investigational Site Number 642202

    Oradea, 410598

  • Sanofi-Aventis Investigational Site Number 642206

    Târgu Mureş, 540061

  • Sanofi-Aventis Investigational Site Number 642207

    Timișoara, 300456

  • Sanofi-Aventis Investigational Site Number 642201

    Timișoara, 300593

Other trials in Romania

Argentina7 sites

  • Sanofi-Aventis Investigational Site Number 032204

    Buenos Aires

  • Sanofi-Aventis Investigational Site Number 032205

    Capital Federal, 1012

  • Sanofi-Aventis Investigational Site Number 032201

    Capital Federal, 1425

  • Sanofi-Aventis Investigational Site Number 032209

    Capital Federal, C1056ABJ

  • Sanofi-Aventis Investigational Site Number 032211

    Corrientes

  • Sanofi-Aventis Investigational Site Number 032202

    Paraná, (E3100BBJ)

  • Sanofi-Aventis Investigational Site Number 032203

    Rosario, 2000

Other trials in Argentina

Hungary7 sites

  • Sanofi-Aventis Investigational Site Number 348205

    Balatonfüred, 8230

  • Sanofi-Aventis Investigational Site Number 348202

    Budapest, 1036

  • Sanofi-Aventis Investigational Site Number 348207

    Budapest

  • Sanofi-Aventis Investigational Site Number 348204

    Debrecen, 4031

  • Sanofi-Aventis Investigational Site Number 348206

    Gyula, 5700

  • Sanofi-Aventis Investigational Site Number 348203

    Szeged, 6722

  • Sanofi-Aventis Investigational Site Number 348201

    Zalaegerszeg, 8900

Other trials in Hungary

Poland7 sites

  • Sanofi-Aventis Investigational Site Number 616202

    Krakow, 31-548

  • Sanofi-Aventis Investigational Site Number 616208

    Lubin, 59-300

  • Sanofi-Aventis Investigational Site Number 616206

    Płock, 09-400

  • Sanofi-Aventis Investigational Site Number 616207

    Puławy, 24-100

  • Sanofi-Aventis Investigational Site Number 616205

    Sopot, 81-756

  • Sanofi-Aventis Investigational Site Number 616201

    Szczecin, 70-506

  • Sanofi-Aventis Investigational Site Number 616203

    Zabrze, 41-8--

Other trials in Poland

Chile6 sites

  • Sanofi-Aventis Investigational Site Number 152202

    Santiago, 7500010

  • Sanofi-Aventis Investigational Site Number 152203

    Santiago, 7980378

  • Sanofi-Aventis Investigational Site Number 152206

    Santiago, 8053095

  • Sanofi-Aventis Investigational Site Number 152204

    Santiago, 8360156

  • Sanofi-Aventis Investigational Site Number 152205

    Santiago, 8930211

  • Sanofi-Aventis Investigational Site Number 152201

    Santiago

Other trials in Chile

France5 sites

  • Sanofi-Aventis Investigational Site Number 250204

    Amiens, 80054

  • Sanofi-Aventis Investigational Site Number 250206

    La Rochelle, 17019

  • Sanofi-Aventis Investigational Site Number 250203

    Le Creusot, 71200

  • Sanofi-Aventis Investigational Site Number 250201

    Nantes, 44093

  • Sanofi-Aventis Investigational Site Number 250202

    Pierre-Bénite, 69310

Other trials in France

Mexico5 sites

  • Sanofi-Aventis Investigational Site Number 484201

    Cuernavaca, 62250

  • Sanofi-Aventis Investigational Site Number 484204

    Durango, 34270

  • Sanofi-Aventis Investigational Site Number 484203

    Guadalajara, 44600

  • Sanofi-Aventis Investigational Site Number 484206

    México, 14050

  • Sanofi-Aventis Investigational Site Number 484205

    Tlalnepantla, 53160

Other trials in Mexico

Sweden5 sites

  • Sanofi-Aventis Investigational Site Number 752204

    Gothenburg, 413 45

  • Sanofi-Aventis Investigational Site Number 752203

    Härnösand, 871 82

  • Sanofi-Aventis Investigational Site Number 752205

    Luleå, 972 33

  • Sanofi-Aventis Investigational Site Number 752202

    Malmö, 211 52

  • Sanofi-Aventis Investigational Site Number 752201

    Stockholm, 111 57

Other trials in Sweden

Ukraine5 sites

  • Sanofi-Aventis Investigational Site Number 804203

    Chernivtsi, 58022

  • Sanofi-Aventis Investigational Site Number 804201

    Kiev, 2091

  • Sanofi-Aventis Investigational Site Number 804205

    Kyiv, 31156

  • Sanofi-Aventis Investigational Site Number 804202

    Kyiv

  • Sanofi-Aventis Investigational Site Number 804204

    Vinnytsia, 21010

Other trials in Ukraine

Brazil4 sites

  • Sanofi-Aventis Investigational Site Number 076207

    Belém, 66073-000

  • Sanofi-Aventis Investigational Site Number 076202

    Brasília, 71625-009

  • Sanofi-Aventis Investigational Site Number 076205

    Porto Alegre, 90035001

  • Sanofi-Aventis Investigational Site Number 076204

    São Paulo, 04024-002

Other trials in Brazil

Estonia4 sites

  • Sanofi-Aventis Investigational Site Number 233201

    Pärnu, 80018

  • Sanofi-Aventis Investigational Site Number 233203

    Tallinn, 13415

  • Sanofi-Aventis Investigational Site Number 233204

    Tartu, 50410

  • Sanofi-Aventis Investigational Site Number 233202

    Viljandimaa, 71024

Other trials in Estonia

Israel4 sites

  • Sanofi-Aventis Investigational Site Number 376202

    Haifa, 31096

  • Sanofi-Aventis Investigational Site Number 376201

    Holon, 58100

  • Sanofi-Aventis Investigational Site Number 376204

    Kfar Saba, 44281

  • Sanofi-Aventis Investigational Site Number 376203

    Tel HaShomer, 52621

Other trials in Israel

Taiwan4 sites

  • Sanofi-Aventis Investigational Site Number 158204

    Changhua, 500

  • Sanofi-Aventis Investigational Site Number 158203

    Taichung, 433

  • Sanofi-Aventis Investigational Site Number 158201

    Taichung R.o.c., 407

  • Sanofi-Aventis Investigational Site Number 158202

    Tainan Hsien, 710

Other trials in Taiwan

Colombia3 sites

  • Sanofi-Aventis Investigational Site Number 170204

    Barranquilla

  • Sanofi-Aventis Investigational Site Number 170201

    Bogotá

  • Sanofi-Aventis Investigational Site Number 170202

    Bogotá

Other trials in Colombia

Denmark3 sites

  • Sanofi-Aventis Investigational Site Number 208202

    Frederiksberg, 2000

  • Sanofi-Aventis Investigational Site Number 208201

    København NV, 2400

  • Sanofi-Aventis Investigational Site Number 208205

    Slagelse, 4200

Other trials in Denmark

Germany3 sites

  • Sanofi-Aventis Investigational Site Number 276201

    Dresden, 01307

  • Sanofi-Aventis Investigational Site Number 276202

    Mainz, 55116

  • Sanofi-Aventis Investigational Site Number 276204

    Saint Ingbert-Oberwürzbach, 66386

Other trials in Germany

Netherlands3 sites

  • Sanofi-Aventis Investigational Site Number 528203

    Amsterdam, 1066 EC

  • Sanofi-Aventis Investigational Site Number 528202

    Groningen, 9728 NT

  • Sanofi-Aventis Investigational Site Number 528204

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

South Africa3 sites

  • Sanofi-Aventis Investigational Site Number 710202

    Cape Town, 7708

  • Sanofi-Aventis Investigational Site Number 710201

    Durban, 4092

  • Sanofi-Aventis Investigational Site Number 710203

    Pretoria

Other trials in South Africa

Czechia2 sites

  • Sanofi-Aventis Investigational Site Number 203202

    Hradec Králové, 50005

  • Sanofi-Aventis Investigational Site Number 203204

    Prague, 15006

Other trials in Czechia

Italy2 sites

  • Sanofi-Aventis Investigational Site Number 380201

    Milan, 20132

  • Sanofi-Aventis Investigational Site Number 380202

    Perugia, 61260

Other trials in Italy

Malaysia2 sites

  • Sanofi-Aventis Investigational Site Number 458203

    Kelantan, 16150

  • Sanofi-Aventis Investigational Site Number 458202

    Kuala Lumpur, 56000

Other trials in Malaysia

Puerto Rico2 sites

  • Sanofi-Aventis Investigational Site Number 840226

    Ponce, 00717

  • Sanofi-Aventis Investigational Site Number 840216

    San Juan, 00917

Other trials in Puerto Rico

Russia2 sites

  • Sanofi-Aventis Investigational Site Number 643202

    Saint Petersburg, 194358

  • Sanofi-Aventis Investigational Site Number 643203

    Saratov, 410030

Other trials in Russia

About this study

Official title: A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment.

The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

Read the detailed description

The study comprises 3 periods:

  • An up to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs.
  • At the end of the run-in phase, patients whose HbA1c (centralized assay) is greater than or equal to (>=) 7% and less than or equal to (<=) 9% and whose mean fasting self-monitored plasma glucose (SMPG) calculated from the self measurements for the 7 days prior to Visit 12 (Week -1) is <=140 milligram per deciliter (mg/dL) (7.8 millimole per liter [mmol/L]), would enter a 24-week double-blind randomized treatment period comparing lixisenatide to placebo (on top of insulin glargine + metformin +/- TZDs).
  • A 3-day safety follow up period.

Maximum duration is of 39 weeks +/- 7 days.

Being tested
Lixisenatide (AVE0010), Placebo, Insulin glargine, Pen auto-injector, Metformin
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.

  • Insulin glargineDrug

    Also called Lantus®

    Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.

  • Pen auto-injectorDevice

    Lantus® SoloStar® OptiClik®

  • MetforminDrug

    Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

  • Thiazolidinedione (TZD)Drug

    TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

Study groups in NCT00975286
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 Week 24.
Receives: Drug: Lixisenatide (AVE0010); Drug: Insulin glargine; Device: Pen auto-injector; Drug: Metformin; Drug: Thiazolidinedione (TZD)
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 Week 24.
Receives: Drug: Placebo; Drug: Insulin glargine; Device: Pen auto-injector; Drug: Metformin; Drug: Thiazolidinedione (TZD)

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 the time from the first dose of study drug up to 14 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: Baseline, Week 24

Secondary outcomes (10)

  1. Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24

    The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day 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: Baseline, Week 24

  2. Change From Baseline in Glucose Excursion at Week 24

    Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day 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: Baseline, Week 24

  3. Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24

    Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day 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: Baseline, Week 24

  4. 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 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: Baseline, Week 24

  5. Change From Baseline in Average Insulin Glargine Daily Dose at Week 24

    Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day 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: Baseline, Week 24

  6. 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 the time from the first dose of study drug up to 1 day 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: Baseline, Week 24

  7. 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 14 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

  8. Percentage of Patients With Glycosylated Hemoglobin (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 14 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

  9. Percentage of Patients Requiring Rescue Therapy During the Double-blind Period

    Routine fasting SMPG, central laboratory FPG and HbA1c 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 were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c >9%, from Week 8 to Week 24: fasting SMPG/FPG >180 mg/dL (10.0 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

  10. Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24

    Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. 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: Baseline, 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 posted11 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionAug 2011
  4. Study completionAug 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
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00975286
Sponsor's protocol ID
EFC10781
Other IDs
EudraCT : 2008-007335-40
Acronym
GetGoal-Duo1
Status last verified
Aug 2016
First submitted
10 Sep 2009
Last updated
11 Oct 2016
Data monitoring committee
Yes

Publications

  • Riddle MC, Forst T, Aronson R, Sauque-Reyna L, Souhami E, Silvestre L, Ping L, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013 Sep;36(9):2497-503. doi: 10.2337/dc12-2462. Epub 2013 Apr 5.

    PubMed 23564915

  • Yao J, Zhang M, Zhang X, Zhang J. Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Diabetes Ther. 2023 Apr;14(4):653-669. doi: 10.1007/s13300-023-01369-6. Epub 2023 Feb 21.

    PubMed 36809495

  • Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Clin Diabetes Endocrinol. 2020 Jan 14;6:2. doi: 10.1186/s40842-019-0088-5. eCollection 2020.

    PubMed 31956422

  • 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.

    PubMed 29974618

  • Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. J Diabetes Complications. 2014 Nov-Dec;28(6):880-6. doi: 10.1016/j.jdiacomp.2014.07.007. Epub 2014 Jul 18.

    PubMed 25130920

  • Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013 Sep;36(9):2489-96. doi: 10.2337/dc12-2454. Epub 2013 Apr 29.

    PubMed 23628617

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lixisenatide (AVE0010), Insulin glargine and Pen auto-injector in people with Type 2 Diabetes Mellitus, run by Sanofi at 140 sites in 26 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 25 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 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Canada, India, Romania, Argentina and 21 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 NCT00975286, which also lists 6 linked publications.

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 11 Oct 2016.

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