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AzTrials

Type 2 DiabetesPhase 3GetGoal-Duo-2NCT01768559

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

A Phase 3 study testing Lixisenatide (AVE0010), Insulin glulisine QD and Insulin glulisine TID in people with Type 2 Diabetes, run by Sanofi at 199 sites in 18 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

Primary Objective: To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Lixisenatide (AVE0010), Insulin glulisine QD and Insulin glulisine TID
Could I receive a placebo?
No, everyone receives an active treatment
How many people
894 participants
Where
199 sitesin 18 countries
Study dates
Jan 2013to Dec 2014
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

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

Who cannot join

  • At screening: age < legal age of majority.
  • At screening, HbA1c: <7.5% and >10.0% for participants treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide.
  • Women of childbearing potential with no effective contraceptive method, pregnancy or lactation.
  • Type 1 diabetes mellitus.
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
  • Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
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  • Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.
  • At screening, Body Mass Index (BMI) ≤20 or >40 kg/m^2.
  • Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
  • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
  • At screening resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposed to MTC (e.g. multiple endocrine neoplasia syndromes).
  • Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
  • Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
  • At screening, amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN).
  • At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
  • At screening calcitonin ≥20 pg/ml (5.9 pmol/L).
  • Exclusion Criteria for randomization at the end of the screening period before randomization:
  • HbA1c <7.0% or >9.0%.
  • 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).
  • Amylase and/or lipase >3 times ULN.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

199 sites in 18 countries.

199 sites in 18 countries

United States46 sites

  • Investigational Site Number 840004

    Avon, Indiana, 46123

  • Investigational Site Number 840055

    Avon, Indiana, 46123

  • Investigational Site Number 840016

    Baltimore, Maryland, 21237

  • Investigational Site Number 840025

    Buckley, Michigan, 49620

  • Investigational Site Number 840032

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840024

    Chicago, Illinois, 60611

  • Investigational Site Number 840034

    Corpus Christi, Texas, 78404

  • Investigational Site Number 840001

    Dallas, Texas, 75230

  • Investigational Site Number 840048

    Dearborn, Michigan, 48124

  • Investigational Site Number 840041

    Denver, Colorado, 80246

  • Investigational Site Number 840027

    Des Moines, Iowa, 50314

  • Investigational Site Number 840009

    Evanston, Illinois, 60201

  • Investigational Site Number 840028

    Fargo, North Dakota, 58103

  • Investigational Site Number 840020

    Houston, Texas, 77081

  • Investigational Site Number 840026

    Kalamazoo, Michigan, 49048

  • Investigational Site Number 840031

    La Mesa, California, 91942

  • Investigational Site Number 840049

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840045

    Lawrenceville, Georgia, 30045

  • Investigational Site Number 840047

    Lexington, Kentucky, 40504

  • Investigational Site Number 840003

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840022

    Marrero, Louisiana, 70072

  • Investigational Site Number 840012

    Miami, Florida, 33136

  • Investigational Site Number 840061

    Miami, Florida, 33142

  • Investigational Site Number 840010

    Milwaukee, Wisconsin, 53217

  • Investigational Site Number 840005

    Mission Viejo, California, 92691

  • Investigational Site Number 840052

    Myrtle Beach, South Carolina, 29572

  • Investigational Site Number 840036

    Nampa, Idaho, 83686

  • Investigational Site Number 840033

    Nashville, Tennessee, 37232

  • Investigational Site Number 840029

    New Hyde Park, New York, 11042

  • Investigational Site Number 840018

    Norfolk, Virginia, 23502

  • Investigational Site Number 840057

    Northridge, California, 91325

  • Investigational Site Number 840007

    Oklahoma City, Oklahoma, 73104

  • Investigational Site Number 840056

    Paducah, Kentucky, 42003

  • Investigational Site Number 840021

    Pittsburgh, Pennsylvania, 15212

  • Investigational Site Number 840017

    Rockville, Maryland, 20852

  • Investigational Site Number 840015

    Salem, Virginia, 24153

  • Investigational Site Number 840011

    Salisbury, North Carolina, 28144

  • Investigational Site Number 840035

    Santa Ana, California, 92704

  • Investigational Site Number 840060

    Smithtown, New York, 11787

  • Investigational Site Number 840030

    Staten Island, New York, 10301-3914

  • Investigational Site Number 840043

    Sun City, Arizona, 85351

  • Investigational Site Number 840002

    Temecula, California, 92591

  • Investigational Site Number 840042

    Tempe, Arizona, 85282

  • Investigational Site Number 840037

    Walnut Creek, California, 94598

  • Investigational Site Number 840023

    West Hills, California, 91345

  • Investigational Site Number 840006

    Wichita, Kansas, 67203

Other trials in United States

Canada18 sites

  • Investigational Site Number 124008

    Brampton, L6R 3J5

  • Investigational Site Number 124015

    Burlington, L7M 4Y1

  • Investigational Site Number 124018

    Chatham, N7L 1C1

  • Investigational Site Number 124004

    Coquitlam, V3K 3P4

  • Investigational Site Number 124016

    Etobicoke, M9R 4E1

  • Investigational Site Number 124014

    Hamilton, L8L 5G8

  • Investigational Site Number 124020

    Montreal, H1Y 3L1

  • Investigational Site Number 124011

    Montreal, H3A 1A1

  • Investigational Site Number 124017

    Newmarket, L3Y 5G8

  • Investigational Site Number 124021

    Québec, G1N 4V3

  • Investigational Site Number 124003

    Red Deer, T4N 6V7

  • Investigational Site Number 124012

    Saint Romuald, G6W 5M6

  • Investigational Site Number 124002

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124001

    Toronto, M4G 3E8

  • Investigational Site Number 124010

    Toronto, M5C 2T2

  • Investigational Site Number 124005

    Vancouver, V5Z 1M9

  • Investigational Site Number 124006

    Victoria, V8V 4A1

  • Investigational Site Number 124007

    Winnipeg, R3E 3P4

Other trials in Canada

Romania17 sites

  • Investigational Site Number 642105

    Bacau, 600114

  • Investigational Site Number 642108

    Cluj-Napoca, 400006

  • Investigational Site Number 642106

    Deva, 330084

  • Investigational Site Number 642113

    Galati, 800098

  • Investigational Site Number 642107

    Hunedoara, 331057

  • Investigational Site Number 642117

    Iași, 700547

  • Investigational Site Number 642103

    Oradea, 410169

  • Investigational Site Number 642104

    Oradea, 410169

  • Investigational Site Number 642112

    Piteşti, 110084

  • Investigational Site Number 642114

    Ploieşti, 100342

  • Investigational Site Number 642102

    Reşiţa, 320076

  • Investigational Site Number 642111

    Sibiu, 550371

  • Investigational Site Number 642109

    Târgu Mureş, 540142

  • Investigational Site Number 642110

    Târgu Mureş, 540142

  • Investigational Site Number 642116

    Timișoara, 300133

  • Investigational Site Number 642101

    Timișoara, 300456

  • Investigational Site Number 642115

    Timișoara, 300723

Other trials in Romania

Germany13 sites

  • Investigational Site Number 276112

    Bad Mergentheim, 97980

  • Investigational Site Number 276108

    Berlin, 13125

  • Investigational Site Number 276102

    Dortmund, 44137

  • Investigational Site Number 276120

    Dresden, 01067

  • Investigational Site Number 276106

    Dresden, 01307

  • Investigational Site Number 276117

    Frankfurt A.M., 60596

  • Investigational Site Number 276116

    Görlitz, 02826

  • Investigational Site Number 276113

    Heidelberg, 69115

  • Investigational Site Number 276118

    Leipzig, 04103

  • Investigational Site Number 276119

    Magdeburg, 39104

  • Investigational Site Number 276103

    Neumünster, 24534

  • Investigational Site Number 276109

    Saint Ingbert-Oberwürzbach, 66386

  • Investigational Site Number 276115

    Speyer, 67346

Other trials in Germany

United Kingdom12 sites

  • Investigational Site Number 826006

    Ashton-under-Lyne, OL6 9RW

  • Investigational Site Number 826002

    Birmingham, B9 5SS

  • Investigational Site Number 826007

    Carmarthen, SA31 2AF

  • Investigational Site Number 826005

    Chester, CH2 1UL

  • Investigational Site Number 826008

    Coventry, CV1 4FH

  • Investigational Site Number 826009

    Dundee, DD1 9SI

  • Investigational Site Number 826001

    Durham, DH1 5TW

  • Investigational Site Number 826011

    Haddington, EH41 3PF

  • Investigational Site Number 826012

    Leicester, LE5 4PW

  • Investigational Site Number 826010

    Plymouth, PL6 8BX

  • Investigational Site Number 826004

    Sheffield, S5 7AU

  • Investigational Site Number 826003

    St Helens, WA93DA

Other trials in United Kingdom

Mexico11 sites

  • Investigational Site Number 484108

    Chihuahua City, 31200

  • Investigational Site Number 484101

    Cuernavaca, 62250

  • Investigational Site Number 484111

    Durango, 34080

  • Investigational Site Number 484104

    Guadalajara, 44150

  • Investigational Site Number 484109

    Guadalajara, 44210

  • Investigational Site Number 484107

    Guadalajara, 44600

  • Investigational Site Number 484105

    Guadalajara, 44650

  • Investigational Site Number 484110

    Guadalajara, 44656

  • Investigational Site Number 484102

    México, 06700

  • Investigational Site Number 484103

    Mexico City, 11850

  • Investigational Site Number 484106

    Monterrey, 64000

Other trials in Mexico

Russia11 sites

  • Investigational Site Number 643111

    Moscow, 117036

  • Investigational Site Number 643107

    Moscow, 119991

  • Investigational Site Number 643105

    Moscow, 129110

  • Investigational Site Number 643110

    Penza, 440026

  • Investigational Site Number 643101

    Saint Petersburg, 194044

  • Investigational Site Number 643104

    Saint Petersburg, 194354

  • Investigational Site Number 643109

    Saint Petersburg, 194354

  • Investigational Site Number 643106

    Saint Petersburg, 194358

  • Investigational Site Number 643108

    Saint Petersburg, 195112

  • Investigational Site Number 643103

    Saint Petersburg, 195257

  • Investigational Site Number 643102

    Saratov, 410030

Other trials in Russia

France9 sites

  • Investigational Site Number 250108

    Bois-Guillaume, 76230

  • Investigational Site Number 250105

    Corbeil-Essonnes, 91100

  • Investigational Site Number 250104

    La Rochelle, 17019

  • Investigational Site Number 250106

    Lyon, 69495

  • Investigational Site Number 250107

    Lyon, 69495

  • Investigational Site Number 250109

    Mantes-la-Jolie, 78200

  • Investigational Site Number 250102

    Paris, 75908

  • Investigational Site Number 250101

    Vandœuvre-lès-Nancy, 54511

  • Investigational Site Number 250103

    Vénissieux, 69200

Other trials in France

Chile8 sites

  • Investigational Site Number 152103

    Santiago, 7500010

  • Investigational Site Number 152107

    Santiago, 7500347

  • Investigational Site Number 152101

    Santiago, 7500710

  • Investigational Site Number 152105

    Santiago, 7591047

  • Investigational Site Number 152102

    Santiago, 7980378

  • Investigational Site Number 152106

    Santiago, 8053095

  • Investigational Site Number 152108

    Santiago, 8053095

  • Investigational Site Number 152109

    Santiago

Other trials in Chile

Czechia8 sites

  • Investigational Site Number 203107

    Beroun, 26601

  • Investigational Site Number 203103

    Jílové u Prahy, 254 01

  • Investigational Site Number 203101

    Ostrava, 702 00

  • Investigational Site Number 203110

    Police nad Metují, 549 54

  • Investigational Site Number 203105

    Prague, 14021

  • Investigational Site Number 203102

    Prague, 148 00

  • Investigational Site Number 203108

    Prague, 14900

  • Investigational Site Number 203104

    Trutnov, 54101

Other trials in Czechia

Hungary8 sites

  • Investigational Site Number 348107

    Budapest, 1134

  • Investigational Site Number 348108

    Budapest, 1138

  • Investigational Site Number 348102

    Budapest, 1139

  • Investigational Site Number 348101

    Eger, 3300

  • Investigational Site Number 348103

    Pápa, 8500

  • Investigational Site Number 348106

    Sátoraljaújhely, 3980

  • Investigational Site Number 348104

    Szeged, 6720

  • Investigational Site Number 348105

    Zalaegerszeg, 8900

Other trials in Hungary

Ukraine8 sites

  • Investigational Site Number 804104

    Chernivtsi, 58022

  • Investigational Site Number 804107

    Donetsk, 83003

  • Investigational Site Number 804103

    Donetsk, 83059

  • Investigational Site Number 804108

    Mykolaiv, 54003

  • Investigational Site Number 804110

    Odesa, 65059

  • Investigational Site Number 804105

    Vinnytsia, 21001

  • Investigational Site Number 804102

    Vinnytsia, 21010

  • Investigational Site Number 804111

    Zaporizhia, 69600

Other trials in Ukraine

Poland7 sites

  • Investigational Site Number 616101

    Bialystok, 15-435

  • Investigational Site Number 616103

    Bydgoszcz, 85-822

  • Investigational Site Number 616102

    Bytom, 41-902

  • Investigational Site Number 616106

    Krakow, 31-455

  • Investigational Site Number 616104

    Krakow, 31-548

  • Investigational Site Number 616105

    Puławy, 24-100

  • Investigational Site Number 616107

    Warsaw, 02-507

Other trials in Poland

Italy5 sites

  • Investigational Site Number 380103

    Bologna, 40138

  • Investigational Site Number 380102

    Catania, 95122

  • Investigational Site Number 380101

    Milan, 20132

  • Investigational Site Number 380105

    Naples, 80131

  • Investigational Site Number 380104

    Torino, 10126

Other trials in Italy

Latvia5 sites

  • Investigational Site Number 428103

    Jelgava, LV-3001

  • Investigational Site Number 428104

    Ogre, LV-5001

  • Investigational Site Number 428102

    Riga, LV-1002

  • Investigational Site Number 428105

    Riga, LV-1006

  • Investigational Site Number 428101

    Sigulda, LV-2150

Other trials in Latvia

Lithuania5 sites

  • Investigational Site Number 440104

    Jonava, LT-55201

  • Investigational Site Number 440103

    Kaunas, LT-48259

  • Investigational Site Number 440102

    Kaunas, LT-49456

  • Investigational Site Number 440101

    Kaunas, LT-51270

  • Investigational Site Number 440105

    Klaipėda, LT-92288

Other trials in Lithuania

Estonia4 sites

  • Investigational Site Number 233102

    Pärnu, 80018

  • Investigational Site Number 233103

    Tallinn, 13415

  • Investigational Site Number 233104

    Tallinn, 13419

  • Investigational Site Number 233101

    Viljandimaa, 71024

Other trials in Estonia

Spain4 sites

  • Investigational Site Number 724105

    A Coruña, 15006

  • Investigational Site Number 724102

    Ferrol, 15403

  • Investigational Site Number 724103

    Málaga, 29010

  • Investigational Site Number 724104

    Seville, 41010

Other trials in Spain

About this study

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

Primary Objective:

  • To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

  • To compare the treatments/regimens on:
  • The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,
  • Body weight,
  • Self-Monitored Glucose profiles,
  • Fasting Plasma Glucose (FPG),
  • Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),
  • Daily doses of insulins,
  • Safety and tolerability.
Read the detailed description

Approximately 41 weeks including a 26 week treatment period.

Conditions
Type 2 Diabetes
Being tested
Lixisenatide (AVE0010), Insulin glulisine QD, Insulin glulisine TID, Insulin Glargine (Mandatory background drug), Metformin (Background drug)
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

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

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

  • Insulin glulisine QDDrug

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

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

  • Insulin glulisine TIDDrug

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

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

  • Insulin Glargine (Mandatory background drug)Drug

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

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

  • Metformin (Background drug)Drug

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

Study groups in NCT01768559
Study groupRoleWhat they receive
LixisenatideExperimentalLixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
Receives: Drug: Lixisenatide (AVE0010); Drug: Insulin Glargine (Mandatory background drug); Drug: Metformin (Background drug)
Insulin Glulisine QDActive comparatorInsulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Receives: Drug: Insulin glulisine QD; Drug: Insulin Glargine (Mandatory background drug); Drug: Metformin (Background drug)
Insulin Glulisine TIDActive comparatorInsulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Receives: Drug: Insulin glulisine TID; Drug: Insulin Glargine (Mandatory background drug); Drug: Metformin (Background drug)

What is being measured

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

  1. Change in HbA1c From Baseline to Week 26

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

    Measured: Baseline, Week 26

  2. Change in Body Weight From Baseline to Week 26

    Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.

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

    Measured: Baseline, Week 26

Secondary outcomes (13)

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

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

    Measured: Week 26

  2. Percentage of Participants With no Weight Gain at Week 26

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

    Measured: Week 26

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

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

    Measured: Baseline, Week 26

  4. Change in FPG From Baseline to Week 26

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

    Measured: Baseline, Week 26

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

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

    Measured: Baseline, Week 26

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

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

    Measured: Baseline, Week 26

  7. Change in Insulin Glargine Dose From Baseline to Week 26

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

    Measured: Baseline, Week 26

  8. Insulin Glulisine Dose at Week 26

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

    Measured: Week 26

  9. Total Insulin Dose at Week 26

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

    The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9.

    Measured: Week 26

  10. Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia

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

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

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

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

    Measured: Week 26

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

    The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.

    Measured: Week 26

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

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

    Measured: Week 26

Timeline

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

  1. First posted15 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

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
None (open label)
Enrolment
894 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01768559
Sponsor's protocol ID
EFC12626
Other IDs
2012-004096-38, U1111-1131-4936
Acronym
GetGoal-Duo-2
Status last verified
Nov 2016
First submitted
11 Jan 2013
Last updated
4 Jan 2017
Data monitoring committee
No

Publications

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

    PubMed 27222510

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

    PubMed 31848983

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lixisenatide (AVE0010), Insulin glulisine QD and Insulin glulisine TID in people with Type 2 Diabetes, run by Sanofi at 199 sites in 18 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 4 inclusion and 23 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in United States, Canada, Romania, Germany, United Kingdom and 13 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. 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 4 Jan 2017). 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?

Change in HbA1c From Baseline to Week 26 (time frame: Baseline, Week 26). The study lists 2 primary outcomes in all. 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 NCT01768559, which also lists 3 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 4 Jan 2017.

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