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AzTrials

Type 2 Diabetes MellitusPhase 3LixiLan-GNCT02787551

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

A Phase 3 study testing Insulin glargine/lixisenatide fixed ratio combination, liraglutide and exenatide in people with Type 2 Diabetes Mellitus, run by Sanofi at 124 sites in 9 countries.

Completed

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

Official record
Search all trials

Trial summary

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. 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?
Insulin glargine/lixisenatide fixed ratio combination, liraglutide and exenatide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
514 participants
Where
124 sitesin 9 countries
Study dates
6 Jul 2016to 17 Nov 2018
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 prior to screening visit.
  • Participants who were treated with one of the following GLP-1 receptor agonists for at least 4 months prior to screening visit 1 (V1), and with stable dose for at least 3 months prior to screening visit (V1):
  • Liraglutide (Victoza®) 1.8 milligram (mg) QD or 1.2 mg QD, if the 1.8 mg QD dose was not well tolerated according to the Investigator's judgment or
  • Exenatide (Byetta®) 10 microgram (µg) BID or of 5 µg BID, if 10 µg BID dose was not well tolerated according to the Investigator's judgment
  • in combination with metformin (daily dose greater than equal to [>=] 1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening.
  • or
Show all 12Show fewer
  • Participants who were treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):
  • Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator's judgment,
  • Albiglutide (Tanzeum®) 50 mg QW or 30 mg QW, if 50 mg QW was not well tolerated according to Investigator's judgment,
  • Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW was not well tolerated according to Investigator's judgment
  • in combination with metformin (daily dose ≥1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening;
  • -Signed written informed consent.

Who cannot join

  • At screening visit, age <18.
  • Screening HbA1c <7% and >9%.
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Any use of antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria.
  • Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin [<=10 days] due to intercurrent illness including gestational diabetes was allowed at the discretion of the study physician).
  • Laboratory findings at the time of screening, including:
Show all 23Show fewer
  • Fasting plasma glucose (FPG) >250 mg/dL (13.9 millimoles per litre [mmol/L]),
  • Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),
  • Alanine transaminase or aspartate transaminase >3 ULN,
  • Calcitonin >=20 pg/mL (5.9 pmol/L),
  • Positive pregnancy test.
  • Participant who had renal function impairment with estimated glomerular filtration rate <30mL/min/1.73m^2 (using the Modification of Diet in Renal Disease formula) or end-stage renal disease.
  • Contraindication to use of insulin glargine, or lixisenatide or GLP-1 receptor agonist (Victoza®, Byetta®, Bydureon®, Tanzeum® or Trulicity®) according to local labeling.
  • Any contraindication to metformin or pioglitazone or SGLT2 inhibitor use, according to local labeling.
  • History of hypersensitivity to insulin glargine, or to any of the excipients.
  • History of allergic reaction to any GLP-1 receptor agonist or to meta-cresol.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia type 2 syndromes).
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy.
  • Body mass index <=20 or >40 kg/m^2.
  • Participants in the FRC arm with a rescue therapy and HbA1c >8% at week 22.
  • Participants in the FRC arm who discontinued prematurely from FRC treatment before week 26.
  • Participants in the GLP-1 RA treatment arm after randomization.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

124 sites in 9 countries.

124 sites in 9 countries

United States74 sites

  • Investigational Site Number 8400079

    Albany, New York, 12206

  • Investigational Site Number 8400139

    Austin, Texas, 78749

  • Investigational Site Number 8400049

    Avon, Indiana, 46123

  • Investigational Site Number 8400053

    Avon, Indiana, 46123

  • Investigational Site Number 8400085

    Avon, Indiana, 46123

  • Investigational Site Number 8400120

    Avon, Indiana, 46123

  • Investigational Site Number 8400103

    Bakersfield, California, 93309

  • Investigational Site Number 8400033

    Baltimore, Maryland, 21237

  • Investigational Site Number 8400064

    Birmingham, Alabama, 35205

  • Investigational Site Number 8400090

    Columbia, South Carolina, 29204

  • Investigational Site Number 8400019

    Columbus, Ohio, 43201

  • Investigational Site Number 8400130

    Council Bluffs, Iowa, 51501

  • Investigational Site Number 8400001

    Dallas, Texas, 75230-6885

  • Investigational Site Number 8400056

    Dayton, Ohio, 45439

  • Investigational Site Number 8400071

    Denver, Colorado, 80209

  • Investigational Site Number 8400036

    Denver, Colorado, 80246

  • Investigational Site Number 8400118

    Edinburg, Texas, 78539

  • Investigational Site Number 8400041

    Evansville, Indiana, 47714

  • Investigational Site Number 8400018

    Fargo, North Dakota, 58104

  • Investigational Site Number 8400073

    Fountain Hills, Arizona, 85268

  • Investigational Site Number 8400137

    Fresno, California, 93720

  • Investigational Site Number 8400044

    Henderson, Nevada, 89052

  • Investigational Site Number 8400008

    Houston, Texas, 77004

  • Investigational Site Number 8400109

    Houston, Texas, 77040

  • Investigational Site Number 8400063

    Houston, Texas, 77061

  • Investigational Site Number 8400106

    Houston, Texas, 77081

  • Investigational Site Number 8400043

    Huntington Park, California, 90255

  • Investigational Site Number 8400038

    Indianapolis, Indiana, 46254-5469

  • Investigational Site Number 8400114

    Jacksonville, Florida, 32216

  • Investigational Site Number 8400051

    Jefferson City, Missouri, 65109

  • Investigational Site Number 8400124

    Lamont, California, 93241

  • Investigational Site Number 8400027

    Lancaster, California, 93534

  • Investigational Site Number 8400045

    Lawrenceville, Georgia, 30046

  • Investigational Site Number 8400034

    Lexington, Kentucky, 40503

  • Investigational Site Number 8400091

    Lexington, Kentucky, 40503

  • Investigational Site Number 8400098

    Los Angeles, California, 90017

  • Investigational Site Number 8400013

    Los Angeles, California, 90057

  • Investigational Site Number 8400078

    Marrero, Louisiana, 70072

  • Investigational Site Number 8400125

    Mentor, Ohio, 44060

  • Investigational Site Number 8400032

    Metairie, Louisiana, 70006

  • Investigational Site Number 8400133

    Miami, Florida, 33165

  • Investigational Site Number 8400042

    Mission Hills, California, 91345

  • Investigational Site Number 8400020

    Morehead City, North Carolina, 28557

  • Investigational Site Number 8400088

    New Orleans, Louisiana, 70121

  • Investigational Site Number 8400061

    New York, New York, 10001

  • Investigational Site Number 8400123

    North Massapequa, New York, 11758

  • Investigational Site Number 8400014

    North Richland Hills, Texas, 76180

  • Investigational Site Number 8400006

    Northridge, California, 91325

  • Investigational Site Number 8400099

    Oklahoma City, Oklahoma, 73112

  • Investigational Site Number 8400021

    Orange, California, 92868

  • Investigational Site Number 8400054

    Orem, Utah, 84058

  • Investigational Site Number 8400083

    Papillion, Nebraska, 68046-3136

  • Investigational Site Number 8400047

    Phoenix, Arizona, 85028

  • Investigational Site Number 8400058

    Port Charlotte, Florida, 33952

  • Investigational Site Number 8400126

    Rialto, California, 92377

  • Investigational Site Number 8400025

    Salt Lake City, Utah, 84102

  • Investigational Site Number 8400089

    San Antonio, Texas, 78240

  • Investigational Site Number 8400094

    Santa Ana, California, 92704

  • Investigational Site Number 8400135

    Schertz, Texas, 78154

  • Investigational Site Number 8400129

    Scottdale, Pennsylvania, 15683

  • Investigational Site Number 8400075

    Shavano Park, Texas, 78231

  • Investigational Site Number 8400076

    Smithfield, Pennsylvania, 15478

  • Investigational Site Number 8400096

    Snellville, Georgia, 30078

  • Investigational Site Number 8400023

    Springfield, Illinois, 62711

  • Investigational Site Number 8400095

    Staten Island, New York, 10301

  • Investigational Site Number 8400107

    Sugar Land, Texas, 77478

  • Investigational Site Number 8400084

    Tampa, Florida, 33612

  • Investigational Site Number 8400009

    Ventura, California, 93003

  • Investigational Site Number 8400104

    Warwick, Rhode Island, 02886

  • Investigational Site Number 8400092

    Weber City, Virginia, 24290

  • Investigational Site Number 8400112

    West Palm Beach, Florida, 33401

  • Investigational Site Number 8400067

    West Seneca, New York, 14224

  • Investigational Site Number 8400065

    Wilmington, North Carolina, 28401

  • Investigational Site Number 8400111

    Yonkers, New York, 10704

Other trials in United States

Spain10 sites

  • Investigational Site Number 7240012

    Alzira, 46600

  • Investigational Site Number 7240005

    Barcelona, 08035

  • Investigational Site Number 7240002

    Ferrol, 15405

  • Investigational Site Number 7240008

    Málaga, 29010

  • Investigational Site Number 7240011

    Pozuelo de Alarcón, 28223

  • Investigational Site Number 7240003

    Quart de Poblet, 46930

  • Investigational Site Number 7240006

    Sabadell, 08208

  • Investigational Site Number 7240007

    Seville, 41003

  • Investigational Site Number 7240009

    Seville, 41010

  • Investigational Site Number 7240004

    Seville, 41071

Other trials in Spain

Romania9 sites

  • Investigational Site Number 6420004

    Bacau, 600154

  • Investigational Site Number 6420006

    Brasov, 500097

  • Investigational Site Number 6420001

    Bucharest, 020045

  • Investigational Site Number 6420008

    Buzău, 120203

  • Investigational Site Number 6420003

    Cluj-Napoca, 400006

  • Investigational Site Number 6420002

    Oradea, 410159

  • Investigational Site Number 6420009

    Targoviste, 130083

  • Investigational Site Number 6420007

    Târgu Mureş, 540098

  • Investigational Site Number 6420005

    Timișoara, 300125

Other trials in Romania

Slovakia9 sites

  • Investigational Site Number 7030006

    Bratislava, 85101

  • Investigational Site Number 7030009

    Ľubochňa, 034 91

  • Investigational Site Number 7030002

    Lučenec, 98401

  • Investigational Site Number 7030005

    Malacky, 90101

  • Investigational Site Number 7030007

    Prešov, 08001

  • Investigational Site Number 7030001

    Rožňava, 04801

  • Investigational Site Number 7030008

    Sabinov, 083 01

  • Investigational Site Number 7030004

    Trenčín, 91101

  • Investigational Site Number 7030003

    Žilina, 010 01

Other trials in Slovakia

Italy7 sites

  • Investigational Site Number 3800008

    Bergamo, 24127

  • Investigational Site Number 3800002

    Bologna, 40138

  • Investigational Site Number 3800001

    Milan, 20132

  • Investigational Site Number 3800006

    Milan, 20142

  • Investigational Site Number 3800005

    Naples, 80131

  • Investigational Site Number 3800004

    Roma, 00128

  • Investigational Site Number 3800003

    Roma, 00133

Other trials in Italy

Israel5 sites

  • Investigational Site Number 3760001

    Haifa, 31096

  • Investigational Site Number 3760002

    Haifa, 35152

  • Investigational Site Number 3760005

    Jerusalem, 91120

  • Investigational Site Number 3760006

    Jerusalem, 93106

  • Investigational Site Number 3760004

    Tel Aviv, 6203854

Other trials in Israel

Canada4 sites

  • Investigational Site Number 1240003

    Burlington, L7M 4Y1

  • Investigational Site Number 1240006

    Corunna, N0N 1G0

  • Investigational Site Number 1240002

    Red Deer, T4N 6V7

  • Investigational Site Number 1240001

    Vancouver, V5Y 3W2

Other trials in Canada

Estonia4 sites

  • Investigational Site Number 2330002

    Pärnu, 80018

  • Investigational Site Number 2330003

    Tallinn, 10138

  • Investigational Site Number 2330001

    Tallinn, 13419

  • Investigational Site Number 2330004

    Viljandi, 71024

Other trials in Estonia

Germany2 sites

  • Investigational Site Number 2760001

    Dresden, 01307

  • Investigational Site Number 2760003

    Oldenburg in Holstein, 23758

Other trials in Germany

About this study

Official title: A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.

Secondary Objectives:

To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes.

To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

Read the detailed description

The maximum duration for GLP1-RA participants was approximately 29 weeks: up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety follow-up period.

Maximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period.

All primary and secondary efficacy, safety and other outcome measures were assessed at the end of the extension period.

Being tested
Insulin glargine/lixisenatide fixed ratio combination, liraglutide, exenatide, exenatide extended-release, albiglutide
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.

  • Insulin glargine/lixisenatide fixed ratio combinationDrug

    Also called HOE901/AVE0010, Soliqua

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • liraglutideDrug

    Also called Victoza

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • exenatideDrug

    Also called Byetta

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • exenatide extended-releaseDrug

    Also called Bydureon

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • albiglutideDrug

    Also called Tanzeum

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • dulaglutideDrug

    Also called Trulicity

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)Drug

    Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.

Study groups in NCT02787551
Study groupRoleWhat they receive
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)ExperimentalCore period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted. Single arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.
Receives: Drug: Insulin glargine/lixisenatide fixed ratio combination; Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
GLP-1 Receptor AgonistActive comparatorCore period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily [BID], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
Receives: Drug: liraglutide; Drug: exenatide; Drug: exenatide extended-release; Drug: albiglutide; Drug: dulaglutide; Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)

What is being measured

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

  1. Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period

    Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.

    Measured: Baseline, Week 26

  2. Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period

    Change in HbA1c was calculated by subtracting baseline value from Week 52 value.

    Measured: Baseline, Week 52

Secondary outcomes (16)

  1. Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period

    Participants without any available HbA1c assessment at Week 26 were considered as non-responders.

    Measured: Week 26

  2. Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period

    Participants without any available HbA1c assessment at Week 52 were considered as non-responders.

    Measured: Week 52

  3. Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period

    Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.

    Measured: Baseline, Week 26

  4. Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period

    Change in FPG was calculated by subtracting baseline value from Week 52 value.

    Measured: Baseline, Week 52

  5. Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period

    The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.

    Measured: Baseline, Week 26

  6. Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period

    The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal.

    Measured: Baseline, Week 52

  7. Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period

    The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF).

    Measured: Baseline, Week 26

  8. Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period

    The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.

    Measured: Baseline, Week 52

  9. Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period

    2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF.

    Measured: Baseline, Week 26

  10. Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period

    2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.

    Measured: Baseline, Week 52

  11. Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period

    Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%.

    Measured: From Baseline to Week 26

  12. Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period

    Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%.

    Measured: From Week 26 to Week 52

  13. Change From Baseline in Body Weight at Week 26: Core Period

    Change in body weight was calculated by subtracting baseline value from Week 26 value.

    Measured: Baseline, Week 26

  14. Change From Baseline in Body Weight to Week 52: Single Arm Extension Period

    Change in body weight was calculated by subtracting baseline value from Week 52 value.

    Measured: Baseline, Week 52

  15. Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period

    Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed.

    Measured: From Baseline to Week 26

  16. Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period

    Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed.

    Measured: From Baseline to Week 52

Timeline

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

  1. First posted1 Jun 2016 (estimated)
  2. Study start6 Jul 2016
  3. Primary completion25 May 2018
  4. Study completion17 Nov 2018

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
514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02787551
Sponsor's protocol ID
EFC13794
Other IDs
2014-004850-32, U1111-1168-4639, 2014
Acronym
LixiLan-G
Status last verified
Mar 2022
First submitted
26 May 2016
Last updated
25 Mar 2022
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6.

    PubMed 35332216

  • Ferrannini E, Niemoeller E, Dex T, Servera S, Mari A. Fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) improves ss-cell function in people with type 2 diabetes. Diabetes Obes Metab. 2022 Jun;24(6):1159-1165. doi: 10.1111/dom.14688. Epub 2022 Mar 28.

    PubMed 35257461

  • Guja C, Giorgino F, Blonde L, Ali A, Prazny M, Meier JJ, Souhami E, Lubwama R, Ji C, Rosenstock J. Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results. Diabetes Ther. 2022 Jan;13(1):205-215. doi: 10.1007/s13300-021-01180-1. Epub 2021 Dec 11.

    PubMed 34894329

  • Blonde L, Rosenstock J, Frias J, Birkenfeld AL, Niemoeller E, Souhami E, Ji C, Del Prato S, Aroda VR. Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study. Diabetes Care. 2021 Mar;44(3):774-780. doi: 10.2337/dc20-2023. Epub 2021 Jan 19.

    PubMed 33468520

  • Blonde L, Rosenstock J, Del Prato S, Henry R, Shehadeh N, Frias J, Niemoeller E, Souhami E, Ji C, Aroda VR. Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial. Diabetes Care. 2019 Nov;42(11):2108-2116. doi: 10.2337/dc19-1357. Epub 2019 Sep 17.

    PubMed 31530665

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine/lixisenatide fixed ratio combination, liraglutide and exenatide in people with Type 2 Diabetes Mellitus, run by Sanofi at 124 sites in 9 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 12 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Spain, Romania, Slovakia, Italy and 4 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 12 Jun 2019). 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 From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period (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 NCT02787551, which also lists 5 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 25 Mar 2022.

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