LivingGLP1
Study S001409

A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

Registration

Registration
NCT02058160
Acronym
LixiLan-L
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
736
Start
2014-01
Primary completion
2015-07
Lead sponsor
Sanofi
Conditions
Type 2 Diabetes
Interventions
DRUG:Insulin glargine/lixisenatide (HOE901/AVE0010); DRUG:Insulin glargine (HOE901); DRUG:Metformin (Background Drug)
Results posted
TRUE
Secondary identifiers
EUDRACT_NUMBER:2013-003132-79; OTHER:U1111-1148-4351

Registered primary outcomes

  • Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30 [Baseline, Week 30]

Linked records (17)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0048087Vergleich von iGlarLixi mit einem Basal-Bolusregime bei Patienten mit Typ-2-Diabetes mittels Propensity-Score-Matching (PSM)
JJ Meier, Diabetologie und Stoffwechsel
2021Nonrandomized studyDOIcites ClinicalTrials.gov:NCT02058160
R0048976Einfluss der Typ-2-Diabetesdauer auf die Wirkung von iGlarLixi gegenüber Insulin glargin 100 E / ml bei einer basalunterstützten oralen Therapie (BOT): Eine Subanalyse der LixiLan-L-Studie
Jochen Seufert, Diabetologie und Stoffwechsel
2021OtherDOIcites ClinicalTrials.gov:NCT02058160
R0011584Glycaemic target attainment in people with Type 2 diabetes treated with insulin glargine/lixisenatide fixed-ratio combination: a post hoc analysis of the LixiLan-O and LixiLan-L trials.
Davidson JA, Diabetic medicine : a journal of the British Diabetic Association
2020Other trialPMID 31365765DOIcites ClinicalTrials.gov:NCT02058160
R0015456Efficacy 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.
Tabák ÁG, Diabetes therapy : research, treatment and education of diabetes and related disorders
2020Randomized trialPMID 31848983DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:31848983
R0007277EFFICACY AND SAFETY OF IGLARLIXI IN HISPANICS AND NON-HISPANIC WHITES WITH TYPE 2 DIABETES.
Mora PF, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
2019Randomized trialPMID 31241362DOIcites ClinicalTrials.gov:NCT02058160
R0009425Clinical Characteristics and Glycemic Outcomes of Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial.
Blonde L, Advances in therapy
2019Other trialPMID 31359368DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:31359368
R0012646Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes.
Schmider W, Current medical research and opinion
2019OtherPMID 30550345DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:30550345
R0012665Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world.
Dailey G, BMJ open diabetes research & care
2019Nonrandomized studyPMID 31114694DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:31114694
R0009175Propensity-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.
Rosenstock J, Diabetes, obesity & metabolism
2018Nonrandomized studyPMID 29974618DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:29974618
R0014102Bedtime-to-Morning Glucose Difference and iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of LixiLan-L.
Zisman A, Diabetes therapy : research, treatment and education of diabetes and related disorders
2018Randomized trialPMID 30218434DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:30218434
R0014110Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone.
Trujillo JM, Diabetes, obesity & metabolism
2018Other trialPMID 29923298DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:29923298
R0017480iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L.
Niemoeller E, Diabetes therapy : research, treatment and education of diabetes and related disorders
2018Other trialPMID 29143919DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:29143919
R0047494A1C Target Attainment in Patients with T2D Receiving iGlarLixi Who Reach PPG and FPG Targets in the Lixilan-L Trial
Lawrence A. Leiter, Diabetes
2018Other trialDOIcites ClinicalTrials.gov:NCT02058160
R0049204Relationship of Ethnicity to Clinical Outcomes in iGlarLixi-Treated Patients with Type 2 Diabetes
Pablo Mora, Diabetes
2018Other trialDOIcites ClinicalTrials.gov:NCT02058160
R0013638Consistent findings in glycaemic control, body weight and hypoglycaemia with iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) vs insulin glargine across baseline HbA1c, BMI and diabetes duration categories in the LixiLan-L trial.
Wysham C, Diabetes, obesity & metabolism
2017Randomized trialPMID 28386990DOIcites ClinicalTrials.gov:NCT02058160; registry reference DERIVED:28386990
R0044406Low incidence of gastrointestinal adverse events over time with a combination of insulin glargine and lixisenatide
Bowden Georgina
2017Randomized trialDOIcites ClinicalTrials.gov:NCT02058160
R0018472Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial.
Aroda VR, Diabetes care
2016Randomized trialPMID 27650977DOIcites ClinicalTrials.gov:NCT02058160; registry reference RESULT:27650977