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 (LixiLan-G)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin glargine/lixisenatide fixed ratio combination; Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor); Drug: liraglutide; Drug: exenatide; Drug: exenatide extended-release; Drug: albiglutide; Drug: dulaglutide

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.

• Study Type: Interventional
• Enrollment (Actual): 514
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Burlington, Canada, L7M 4Y1
    • Investigational Site Number 1240003
  • Corunna, Canada, N0N 1G0
    • Investigational Site Number 1240006
  • Red Deer, Canada, T4N 6V7
    • Investigational Site Number 1240002
  • Vancouver, Canada, V5Y 3W2
    • Investigational Site Number 1240001
• Estonia
  • Pärnu, Estonia, 80018
    • Investigational Site Number 2330002
  • Tallinn, Estonia, 13419
    • Investigational Site Number 2330001
  • Tallinn, Estonia, 10138
    • Investigational Site Number 2330003
  • Viljandi, Estonia, 71024
    • Investigational Site Number 2330004
• Germany
  • Dresden, Germany, 01307
    • Investigational Site Number 2760001
  • Oldenburg In Holstein, Germany, 23758
    • Investigational Site Number 2760003
• Israel
  • Haifa, Israel, 31096
    • Investigational Site Number 3760001
  • Haifa, Israel, 35152
    • Investigational Site Number 3760002
  • Jerusalem, Israel, 91120
    • Investigational Site Number 3760005
  • Jerusalem, Israel, 93106
    • Investigational Site Number 3760006
  • Tel Aviv, Israel, 6203854
    • Investigational Site Number 3760004
• Italy
  • Bergamo, Italy, 24127
    • Investigational Site Number 3800008
  • Bologna, Italy, 40138
    • Investigational Site Number 3800002
  • Milano, Italy, 20132
    • Investigational Site Number 3800001
  • Milano, Italy, 20142
    • Investigational Site Number 3800006
  • Napoli, Italy, 80131
    • Investigational Site Number 3800005
  • Roma, Italy, 00128
    • Investigational Site Number 3800004
  • Roma, Italy, 00133
    • Investigational Site Number 3800003
• Romania
  • Bacau, Romania, 600154
    • Investigational Site Number 6420004
  • Brasov, Romania, 500097
    • Investigational Site Number 6420006
  • Bucuresti, Romania, 020045
    • Investigational Site Number 6420001
  • Buzau, Romania, 120203
    • Investigational Site Number 6420008
  • Cluj Napoca, Romania, 400006
    • Investigational Site Number 6420003
  • Oradea, Romania, 410159
    • Investigational Site Number 6420002
  • Targoviste, Romania, 130083
    • Investigational Site Number 6420009
  • Timisoara, Romania, 300125
    • Investigational Site Number 6420005
  • Târgu-Mureş, Romania, 540098
    • Investigational Site Number 6420007
• Slovakia
  • Bratislava, Slovakia, 85101
    • Investigational Site Number 7030006
  • Lubochna, Slovakia, 034 91
    • Investigational Site Number 7030009
  • Lucenec, Slovakia, 98401
    • Investigational Site Number 7030002
  • Malacky, Slovakia, 90101
    • Investigational Site Number 7030005
  • Presov, Slovakia, 08001
    • Investigational Site Number 7030007
  • Roznava, Slovakia, 04801
    • Investigational Site Number 7030001
  • Sabinov, Slovakia, 083 01
    • Investigational Site Number 7030008
  • Trencin, Slovakia, 91101
    • Investigational Site Number 7030004
  • Zilina, Slovakia, 010 01
    • Investigational Site Number 7030003
• Spain
  • Alzira, Spain, 46600
    • Investigational Site Number 7240012
  • Barcelona, Spain, 08035
    • Investigational Site Number 7240005
  • Ferrol, Spain, 15405
    • Investigational Site Number 7240002
  • Málaga, Spain, 29010
    • Investigational Site Number 7240008
  • Pozuelo De Alarcón, Spain, 28223
    • Investigational Site Number 7240011
  • Quart De Poblet, Spain, 46930
    • Investigational Site Number 7240003
  • Sabadell, Spain, 08208
    • Investigational Site Number 7240006
  • Sevilla, Spain, 41003
    • Investigational Site Number 7240007
  • Sevilla, Spain, 41071
    • Investigational Site Number 7240004
  • sEVILLA, Spain, 41010
    • Investigational Site Number 7240009
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Investigational Site Number 8400064
  • Arizona
    • Fountain Hills, Arizona, United States, 85268
      • Investigational Site Number 8400073
    • Phoenix, Arizona, United States, 85028
      • Investigational Site Number 8400047
  • California
    • Bakersfield, California, United States, 93309
      • Investigational Site Number 8400103
    • Fresno, California, United States, 93720
      • Investigational Site Number 8400137
    • Huntington Park, California, United States, 90255
      • Investigational Site Number 8400043
    • Lamont, California, United States, 93241
      • Investigational Site Number 8400124
    • Lancaster, California, United States, 93534
      • Investigational Site Number 8400027
    • Los Angeles, California, United States, 90017
      • Investigational Site Number 8400098
    • Los Angeles, California, United States, 90057
      • Investigational Site Number 8400013
    • Mission Hills, California, United States, 91345
      • Investigational Site Number 8400042
    • Northridge, California, United States, 91325
      • Investigational Site Number 8400006
    • Orange, California, United States, 92868
      • Investigational Site Number 8400021
    • Rialto, California, United States, 92377
      • Investigational Site Number 8400126
    • Santa Ana, California, United States, 92704
      • Investigational Site Number 8400094
    • Ventura, California, United States, 93003
      • Investigational Site Number 8400009
  • Colorado
    • Denver, Colorado, United States, 80209
      • Investigational Site Number 8400071
    • Denver, Colorado, United States, 80246
      • Investigational Site Number 8400036
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Investigational Site Number 8400114
    • Miami, Florida, United States, 33165
      • Investigational Site Number 8400133
    • Port Charlotte, Florida, United States, 33952
      • Investigational Site Number 8400058
    • Tampa, Florida, United States, 33612
      • Investigational Site Number 8400084
    • West Palm Beach, Florida, United States, 33401
      • Investigational Site Number 8400112
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Investigational Site Number 8400045
    • Snellville, Georgia, United States, 30078
      • Investigational Site Number 8400096
  • Illinois
    • Springfield, Illinois, United States, 62711
      • Investigational Site Number 8400023
  • Indiana
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 8400049
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 8400053
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 8400085
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 8400120
    • Evansville, Indiana, United States, 47714
      • Investigational Site Number 8400041
    • Indianapolis, Indiana, United States, 46254-5469
      • Investigational Site Number 8400038
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • Investigational Site Number 8400130
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Investigational Site Number 8400034
    • Lexington, Kentucky, United States, 40503
      • Investigational Site Number 8400091
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Investigational Site Number 8400078
    • Metairie, Louisiana, United States, 70006
      • Investigational Site Number 8400032
    • New Orleans, Louisiana, United States, 70121
      • Investigational Site Number 8400088
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Investigational Site Number 8400033
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Investigational Site Number 8400051
  • Nebraska
    • Papillion, Nebraska, United States, 68046-3136
      • Investigational Site Number 8400083
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Investigational Site Number 8400044
  • New York
    • Albany, New York, United States, 12206
      • Investigational Site Number 8400079
    • New York, New York, United States, 10001
      • Investigational Site Number 8400061
    • North Massapequa, New York, United States, 11758
      • Investigational Site Number 8400123
    • Staten Island, New York, United States, 10301
      • Investigational Site Number 8400095
    • West Seneca, New York, United States, 14224
      • Investigational Site Number 8400067
    • Yonkers, New York, United States, 10704
      • Investigational Site Number 8400111
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Investigational Site Number 8400020
    • Wilmington, North Carolina, United States, 28401
      • Investigational Site Number 8400065
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Investigational Site Number 8400018
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Investigational Site Number 8400019
    • Dayton, Ohio, United States, 45439
      • Investigational Site Number 8400056
    • Mentor, Ohio, United States, 44060
      • Investigational Site Number 8400125
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Investigational Site Number 8400099
  • Pennsylvania
    • Scottdale, Pennsylvania, United States, 15683
      • Investigational Site Number 8400129
    • Smithfield, Pennsylvania, United States, 15478
      • Investigational Site Number 8400076
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Investigational Site Number 8400104
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Investigational Site Number 8400090
  • Texas
    • Austin, Texas, United States, 78749
      • Investigational Site Number 8400139
    • Dallas, Texas, United States, 75230-6885
      • Investigational Site Number 8400001
    • Edinburg, Texas, United States, 78539
      • Investigational Site Number 8400118
    • Houston, Texas, United States, 77004
      • Investigational Site Number 8400008
    • Houston, Texas, United States, 77040
      • Investigational Site Number 8400109
    • Houston, Texas, United States, 77061
      • Investigational Site Number 8400063
    • Houston, Texas, United States, 77081
      • Investigational Site Number 8400106
    • North Richland Hills, Texas, United States, 76180
      • Investigational Site Number 8400014
    • San Antonio, Texas, United States, 78240
      • Investigational Site Number 8400089
    • Schertz, Texas, United States, 78154
      • Investigational Site Number 8400135
    • Shavano Park, Texas, United States, 78231
      • Investigational Site Number 8400075
    • Sugar Land, Texas, United States, 77478
      • Investigational Site Number 8400107
  • Utah
    • Orem, Utah, United States, 84058
      • Investigational Site Number 8400054
    • Salt Lake City, Utah, United States, 84102
      • Investigational Site Number 8400025
  • Virginia
    • Weber City, Virginia, United States, 24290
      • Investigational Site Number 8400092

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• 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

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.

Exclusion criteria:

• 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:
• 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.

Exclusion criteria for the extension period:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC); Core 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.	Drug: Insulin glargine/lixisenatide fixed ratio combination; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: HOE901/AVE0010; Soliqua; Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor); Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.
Active Comparator: GLP-1 Receptor Agonist; Core 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.	Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor); Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.; Drug: liraglutide; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: Victoza; Drug: exenatide; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: Byetta; Drug: exenatide extended-release; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: Bydureon; Drug: albiglutide; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: Tanzeum; Drug: dulaglutide; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: Trulicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 26
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.	Baseline, Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 26
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.	Week 52
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.	Baseline, Week 26
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.	Baseline, Week 52
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.	Baseline, Week 26
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.	Baseline, Week 52
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).	Baseline, Week 26
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.	Baseline, Week 52
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.	Baseline, Week 26
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.	Baseline, Week 52
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%.	From Baseline to Week 26
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%.	From Week 26 to Week 52
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.	Baseline, Week 26
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.	Baseline, Week 52
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.	From Baseline to Week 26
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.	From Baseline to Week 52

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2016
• Primary Completion (Actual): May 25, 2018
• Study Completion (Actual): November 17, 2018

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Liraglutide; Dulaglutide; Hypoglycemic Agents; Metformin; Insulin Glargine; Pioglitazone; Exenatide; Lixisenatide; Sodium-Glucose Transporter 2 Inhibitors; rGLP-1 protein
• Other Study ID Numbers: EFC13794; 2014-004850-32; U1111-1168-4639 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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